TOKYO, July 1, 2020 /PRNewswire/ --Hitachi, Ltd.(TSE: 6501, "Hitachi") and ThinkCyte, Inc. ("ThinkCyte") today announced that they have entered into a collaboration focused on developing an artificial intelligence (AI)-driven cell analysis and sorting system. Hitachi provides a broad range of solutions such as automated cell culture technologies to pharmaceutical companies in the value chain*1 of the regenerative medicine and cell therapy industry. Through the addition of this cell analysis and sorting system to the value chain, Hitachi continues contributing to cost reductions in the manufacturing of regenerative medicine and cell therapy products.Further, Hitachi and ThinkCyte are promoting collaboration with pharmaceutical companies and research institutes working in the field of regenerative medicine and cell therapy to expedite the development of the system toward commercialization.

The practical applications of regenerative medicine and cell therapy using cells for treatment have been expanding rapidly with the first regulatory approval of CAR-T*2 therapy for leukemia in 2017 in the United States and 2019 in Japan. The global market for regenerative medicine and cell therapy is expected to grow from US$ 5.9 billion (JPY 630 billion) in 2020 to US$ 35.4 billion (JPY 3.8 trillion) in 2025*3. In order to scale up treatment using regenerative medicine and cell therapy products, it is critical to ensure consistent selection and stable supply of high quality cells in large quantities and at a low costs.

Hitachi has been providing large-scale automated induced pluripotent stem (iPS) cell culture equipment, cell processing facilities (CPFs), manufacturing execution systems(MES), and biosafety cabinets among other products to pharmaceutical companies and research institutes, and has developed a value chain to meet a variety of customer needs in the regenerative medicine and cell therapy industry. Hitachi has also been carrying out collaborative research projects with universities, research institutes, and other companies to develop core technologies for pharmaceutical manufacturing instruments and in vitro diagnostic medical devices, prototyping for mass production, and working on manufacturing cost reduction and the development of stable and reliable instruments.

ThinkCyte has been performing research and development focused on high-throughput single cell analysis and sorting technology to precisely analyze and isolate target cells. While such single cell analysis and sorting technologies are vital to life science and medical research, it has been thought impossible to achieve high-throughput cell sorting based on high-content image information of every single cell. ThinkCyte has developed the world's first Ghost Cytometrytechnology to achieve high-throughput and high-content single cell sorting*4and has been conducting collaborative research projects with multiple pharmaceutical companies and research institutes to utilize this technology in life science and medical fields.

Hitachi and ThinkCyte have initiated a joint development of the AI-driven cell analysis and sorting system based on their respective technologies, expertise, and know-how. By combining ThinkCyte's high-throughput and high-content label-free single cell sorting technology and Hitachi's know-how and capability to producing stably operative instruments on a large scale, the two companies will together develop a novel reliable system to enable high-speed label-free cell isolation with high accuracy, which has been difficult to achieve with the existing cell sorting techniques, and to realize stable, low-cost and large-scale production of cells for regenerative medicine and cell therapy.

Hitachi and ThinkCyte will further advance partnerships with pharmaceutical companies and research institutes that have been developing and manufacturing regenerative medicines and cell therapy products in Japan and other countries where demand is expected to be significant, such as North America, in order to make this technology a platform for the production of regenerative medicines and cell therapy products. At the same time, taking advantage of the high-speed digital processing technologies cultivated through the development of information and communication technology by the Hitachi group, Hitachi will integrate this safe and highly reliable instrument in its value chain for regenerative medicine and contribute to the growth of the regenerative medicine and cell therapy industry.

Note:

*1. Cell manufacturing processes, including cultivation, selection, modification, preservation, product quality control, etc.

*2. Chimeric Antigen Receptor T cells that have been genetically engineered to produce an artificial T-cell receptor for use in immunotherapy.

*3. Division of Regenerative Medicine, Japan Agency for Medical Research and Development, The final report for market research on regenerative medicine and gene therapy (2020).

*4. S, Ota et al., Ghost Cytometry, Science, 360, 1246-1251 (2018).

About the AI-driven cell analysis and cell sorting technologyThinkCyte has developed high-throughput image-based cell sorting technology based on the Ghost Cytometry technology by integrating the principles of advanced imaging technology, machine learning, and microfluidics. By applying structured illumination to cell imaging, structural information of a single cell can be converted to one-dimensional waveforms for high-throughput data analysis. Based on the judgment of a machine-learning (AI) model developed using the waveform data, target cells are isolated in a microfluidic device with high throughput and with minimal damage to the cells.

This data analysis approach eliminates time-consuming image reconstruction processes and allows high-throughput image-based single cell sorting, enabling the discrimination of cells that were previously considered difficult to distinguish by the human eye. Conventional cell sorting methods rely on the use of labels such as cell surface markers for cell sorting; in contrast, ThinkCyte's technology can sort cells without such labels by employing this unique approach. In addition to the field of regenerative medicine and cell therapy, this technology can also revolutionize drug discovery and in vitrodiagnostics fields.

About Hitachi, Ltd.Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, is focused on its Social Innovation Business that combines information technology (IT), operational technology (OT) and products. The company's consolidated revenues for fiscal year 2019 (ended March 31, 2020) totaled 8,767.2 billion yen ($80.4 billion), and it employed approximately 301,000 people worldwide. Hitachi drives digital innovation across five sectors - Mobility, Smart Life, Industry, Energy and IT - through Lumada, Hitachi's advanced digital solutions, services, and technologies for turning data into insights to drive digital innovation. Its purpose is to deliver solutions that increase social, environmental and economic value for its customers. For more information on Hitachi, please visit the company's website at https://www.hitachi.com.

About ThinkCyte, Inc.ThinkCyte, headquartered in Tokyo, Japan, is a biotechnology company, which developsinnovative life science research, diagnostics,and treatmentsusingintegrated multidisciplinary technologies, founded in 2016. The company focuses on the research and development of drug discovery, cell therapy, and diagnostic platforms using its proprietary image-based high-throughput cell sorting technology In June 2019, the company was selected for J-Startup by the Ministry of Economy, Trade and Industry of Japan. For more information on ThinkCyte, please visit the company's website at https://thinkcyte.com.

ContactsHitachi, Ltd.Analytical Systems Division, Healthcare Division, Smart Life Business Management Divisionhttps://www8.hitachi.co.jp/inquiry/healthcare/en/general/form.jsp

ThinkCyte, Inc.https://thinkcyte.com/contact

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Scope of the Report

The report titled Global Regenerative Medicine Market: Size & Forecast with Impact Analysis of COVID-19 (2020-2024), provides an in-depth analysis of the global regenerative medicine market with description of market sizing and growth. The analysis includes market by value, by product, by material and by region. Furthermore, the report also provides detailed product analysis, material analysis and regional analysis.

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Moreover, the report also assesses the key opportunities in the market and outlines the factors that are and would be driving the growth of the industry. Growth of the overall global regenerative medicine market has also been forecasted for the years 2020-2024, taking into consideration the previous growth patterns, the growth drivers and the current and future trends.

Some of the major players operating in the global regenerative medicine market are Novartis AG, Medtronic Plc, Bristol Myers Squibb (Celgene Corporation) and Smith+Nephew (Osiris Therapeutics, Inc.), whose company profiling has been done in the report. Furthermore, in this segment of the report, business overview, financial overview and business strategies of the respective companies are also provided.

Region Coverage

North AmericaEuropeAsia PacificROW

Company Coverage

Novartis AGMedtronic PlcBristol Myers Squibb (Celgene Corporation)Smith+Nephew (Osiris Therapeutics, Inc.)

Executive Summary

Regenerative medicines emphasis on regeneration or replacement of tissues, cells or organs of human body to cure the problem caused by disease or injury. The treatment fortify human cells to heal up or transplant stem cells into the body to regenerate lost tissues or organs or to recover impaired functionality. There are three types of stem cells that can be used in regenerative medicine: somatic stem cells, embryonic stem cells (ES cells) and induced pluripotent stem cells (iPS cells).

The regenerative medicine also has the capability to treat chronic diseases and conditions, including Alzheimers, diabetes, Parkinsons, heart disease, osteoporosis, renal failure, spinal cord injuries, etc. Regenerative medicines can be bifurcated into different product type i.e., cell therapy, tissue engineering, gene therapy and small molecules and biologics. In addition, on the basis of material regenerative medicine can be segmented into biologically derived material, synthetic material, genetically engineered materials and pharmaceuticals.

The global regenerative medicine market has surged at a progressive rate over the years and the market is further anticipated to augment during the forecasted years 2020 to 2024. The market would propel owing to numerous growth drivers like growth in geriatric population, rising global healthcare expenditure, increasing diabetic population, escalating number of cancer patients, rising prevalence of cardiovascular disease and surging obese population.

Though, the market faces some challenges which are hindering the growth of the market. Some of the major challenges faced by the industry are: legal obligation and high cost of treatment. Whereas, the market growth would be further supported by various market trends like three dimensional bioprinting , artificial intelligence to advance regenerative medicine, etc.

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Table of Contents

1. Executive Summary

2. Introduction

2.1 Regenerative Medicine: An Overview2.2 Regeneration in Humans: An Overview2.3 Expansion in Peripheral Industries of Regenerative Medicine2.4 Approval System for Regenerative Medicine Products2.5 Regenerative Medicine Segmentation

3. Global Market Analysis

3.1 Global Regenerative Medicine Market: An Analysis

3.1.1 Global Regenerative Medicine Market by Value3.1.2 Global Regenerative Medicine Market by Products (Cell Therapy, Tissue Engineering, Gene Therapy and Small Molecules and Biologics)3.1.3 Global Regenerative Medicine Market by Material (Biologically Derived Material, Synthetic Material, Genetically Engineered Materials and Pharmaceuticals)3.1.4 Global Regenerative Medicine Market by Region (North America, Europe, Asia Pacific and ROW)

3.2 Global Regenerative Medicine Market: Product Analysis

3.2.1 Global Cell Therapy Regenerative Medicine Market by Value3.2.2 Global Tissue Engineering Regenerative Medicine Market by Value3.2.3 Global Gene Therapy Regenerative Medicine Market by Value3.2.4 Global Small Molecules and Biologics Regenerative Medicine Market by Value

3.3 Global Regenerative Medicine Market: Material Analysis

3.3.1 Global Biologically Derived Material Market by Value3.3.2 Global Synthetic Material Market by Value3.3.3 Global Genetically Engineered Materials Market by Value3.3.4 Global Regenerative Medicine Pharmaceuticals Market by Value

4. Regional Market Analysis

4.1 North America Regenerative Medicine Market: An Analysis4.1.1 North America Regenerative Medicine Market by Value

4.2 Europe Regenerative Medicine Market: An Analysis4.2.1 Europe Regenerative Medicine Market by Value

4.3 Asia Pacific Regenerative Medicine Market: An Analysis4.3.1 Asia Pacific Regenerative Medicine Market by Value

4.4 ROW Regenerative Medicine Market: An Analysis4.4.1 ROW Regenerative Medicine Market by Value

5. COVID-19

5.1 Impact of Covid-195.2 Response of Industry to Covid-195.3 Variation in Organic Traffic5.4 Regional Impact of COVID-19

6. Market Dynamics

6.1 Growth Drivers6.1.1 Growth in Geriatric Population6.1.2 Rising Global Healthcare Expenditure6.1.3 Increasing Diabetic Population6.1.4 Escalating Number of Cancer Patients6.1.5 Rising Prevalence of Cardiovascular Disease6.1.6 Surging Obese Population

6.2 Challenges6.2.1 Legal Obligation6.2.2 High Cost of Treatment

6.3 Market Trends6.3.1 3D Bio-Printing6.3.2 Artificial Intelligence to Advance Regenerative Medicine

7. Competitive Landscape

7.1 Global Regenerative Medicine Market Players: A Financial Comparison7.2 Global Regenerative Medicine Market Players by Research & Development Expenditure

8. Company Profiles

8.1 Bristol Myers Squibb (Celgene Corporation)8.1.1 Business Overview8.1.2 Financial Overview8.1.3 Business Strategy

8.2 Medtronic Plc8.2.1 Business Overview8.2.2 Financial Overview8.2.3 Business Strategy

8.3 Smith+Nephew (Osiris Therapeutics, Inc.)8.3.1 Business Overview8.3.2 Financial Overview8.3.3 Business Strategy

8.4 Novartis AG8.4.1 Business Overview8.4.2 Financial Overview8.4.3 Business Strategy

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2020-2024 Global Regenerative Medicine Market with Impact Analysis of COVID-19, Production, Revenue, Demand & Applications - Apsters News

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SAN FRANCISCO, June 29, 2020 /PRNewswire/ --Entitled "Randomized, Double Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction: rationale, design and first interim analysis", the presentation provides an initial insight into patient outcomes of the trial that is currently ongoing in multiple centers. Patients included in this trial experienced a severe form of Myocardial Infarction known as STEMI. Soon after the initial intervention to re-establish adequate blood flow to the coronary arteries, patients begin a two-week treatment with Recardio's dutogliptin, a small molecule that enables sustained homing of mobilised stem cells to the site of cardiac injury. By releasing paracrine factors, stem cells have been shown to have significant repair and regenerative effects that improve healing and recovery of cardiac function after the infarction.

More information about the clinical program is available by visiting the "clinicaltrials.gov" website at the following link:https://clinicaltrials.gov/ct2/show/NCT03486080

About Recardio

Recardio Inc. is a clinical-stage life science company focusing ontherapies for cardiovascular, oncology and infectious diseases. The company is located in San Francisco, California, and hasoperations in the USA and Europe.The company's lead drug candidate, dutogliptin, is a DPP-IV inhibitor that has demonstrated significant effects in activating various chemokines like SDF-1, a protein that is critical for cardiac regeneration. In addition to its current Phase 2 cardiovascular clinical program, Recardio will fully develop the therapeutic platform as a regenerative medication for patients with various cardiovascular diseases including acute myocardial infarction and chronic heart failure, with the potential of improving heart function, quality of life and survival.

For more information, visit:http://www.recardio.eu/or contact[emailprotected]

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Interim Analysis of Recardio's Phase II Clinical Trial to Be Presented at the 2020 Congress of the European Society of Cardiology - PRNewswire

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Pune, Maharashtra, India, June 29 2020 (Wiredrelease) Data Bridge Market Research A New Business Intelligence Report released by Data Bridge Market Research with title Global Exosome Therapeutic Market size, share, growth, Industry Trends and Forecast 2027 has abilities to raise as the most significant market worldwide as it has remained playing a remarkable role in establishing progressive impacts on the universal economy. The Global Exosome Therapeutic Market Report offers energetic visions to conclude and study the market size, market hopes, and competitive surroundings. The research is derived through primary and secondary statistics sources and it comprises both qualitative and quantitative detailing. This report has been crafted as the result of persistent efforts lead by knowledgeable forecasters, innovative analysts and brilliant researchers who indulge in detailed and diligent research on different markets, trends and emerging opportunities in the successive direction for the business needs.

Download Exclusive Sample Report (350 Pages PDF with All Related Graphs & Charts) For Free@:https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-exosome-therapeutic-market

DBMR Analyses that the Exosome Therapeutic Market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

Increased number of exosome therapeutics as compared to the past few years will accelerate market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

KNOW YOUR OPTIONS IN THE FIGHT AGAINST COVID-19

The COVID-19 Pandemic has created bottlenecks across industry pipelines, sales funnels, and supply chain activities. This has created unprecedented budget pressure on company spending for industry leaders. This has increased requirement for opportunity analysis, price trend knowledge and competitive outcomes. Use the DBMR team to create new sales channels and capture new markets previously unknown. DBMR helps its clients to grow in these uncertain markets.

To Understand How COVID-19 Impact is covered in This Report. Get Sample Copy of the Report@https://www.databridgemarketresearch.com/request-covid-19/global-exosome-therapeutic-market

The Global Exosome Therapeutic market 2020 research provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Global Exosome Therapeutic Market Share analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins. For each manufacturer covered, this report analyzes their Exosome Therapeutic manufacturing sites, capacity, production, ex-factory price, revenue and market share in global market.

Major Players in Global Exosome Therapeutic Market Include

evox THERAPEUTICSEXOCOBIOExopharmAEGLE TherapeuticsUnited Therapeutics CorporationCodiak BioSciencesJazz Pharmaceuticals, Inc.Boehringer Ingelheim International GmbHReNeuron Group plcCapricor TherapeuticsAvalon Globocare Corp.CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC.Stem Cells Group..

Complete Report is Available (Including Full TOC, List of Tables & Figures, Graphs, and Chart)@https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market

New Exosome Therapeutic Market Developments in 2019

In January 2019, Codiak BioSciences has collaborated with Jazz Pharmaceuticals, Inc. to develop and commercialize exosome therapeutics to treat cancer. The collaboration will help the company to address issues which have been often implicated in solid tumors and hematological malignancies.

In October 2018, Avalon GloboCare Corp. has collaborated with Weill Cornell Medicine to form standards in cGMP-grade for human endothelial cells sourced exosome which is significant for organ regeneration and vascular health and isolation and identification of exosomes sourced from tissue for liquid biopsy and clinical use. The collaboration will help the company to lead market as exosome isolation system as will be first in the world for standardization processing of cGMP-grade exosomes for clinical studies.

In July 2018, Capricor Therapeutics has formed collaboration with the U.S. Army Institute of Surgical Research (USAISR) to discover potential for CAP-2003 (exosomes) in order to address trauma-related conditions and injuries. The collaboration will help to test CAP-2003 as a tool for preservation of life.

This research is categorized differently considering the various aspects of this market. It also evaluates the current situation and the future of the market by using the forecast horizon. The forecast is analyzed based on the volume and revenue of this market. The tools used for analyzing the Global Exosome Therapeutic Market research report include SWOT analysis.

The Global Exosome Therapeutic segments and Market Data Break Down are illuminated below:

By Type (Natural Exosomes, Hybrid Exosomes

By Source (Dendritic Cells, Mesenchymal Stem Cells, Blood, Milk, Body Fluids, Saliva, Urine Others)

By Therapy (Immunotherapy, Gene Therapy, Chemotherapy)

By Transporting Capacity (Bio Macromolecules, Small Molecules

By Application (Oncology, Neurology, Metabolic Disorders, Cardiac Disorders, Blood Disorders, Inflammatory Disorders, Gynecology Disorders, Organ Transplantation, Others)

By Route of administration (Oral, Parenteral)

By End User (Hospitals, Diagnostic Centers, Research & Academic Institutes)

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The Global Exosome Therapeutic Market in terms of investment potential in various segments of the market and illustrate the feasibility of explaining the feasibility of a new project to be successful in the near future. The core segmentation of the global market is based on product types, SMEs and large corporations. The report also collects data for each major player in the market based on current company profiles, gross margins, sales prices, sales revenue, sales volume, photos, product specifications and up-to-date contact information.

What are the strengths and weaknesses of the key vendors?

Definitively, this report will give you an unmistakable perspective on every single reality of the market without a need to allude to some other research report or an information source. Our report will give all of you the realities about the past, present, and eventual fate of the concerned Market.

Scope of the Exosome Therapeutic Market

The global exosome therapeutic market is segmented on the basis of countries into U.S., Mexico, Turkey, Hong Kong, Australia, South Korea, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua and Uruguay.

All country based analysis of the exosome therapeutic market is further analyzed based on maximum granularity into further segmentation. On the basis of type, the market is segmented into natural exosomes and hybrid exosomes. Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. On the basis of therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. On the basis of transporting capacity, the market is segmented into bio macromolecules and small molecules. On the basis of application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. On the basis of route of administration, the market is segmented into pa oral and parenteral. On the basis of end user, the market is segmented into hospitals, diagnostic centers and research & academic institutes and others.

Some Points from Table of Content:

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Regulatory Scenario by Region/Country1.4 Market Investment Scenario Strategic1.5 Market Analysis by Type1.5.1 Global Exosome Therapeutic Market Share by Type (2020-2027)1.5.2 Type 11.5.3 Type 21.5.4 Other1.6 Market by Application1.6.1 Global Exosome Therapeutic Market Share by Application (2020-2027)1.6.2 Application 11.6.3 Application 21.6.4 Other1.7 Exosome Therapeutic Industry Development Trends under COVID-19 Outbreak1.7.1 Region COVID-19 Status Overview1.7.2 Influence of COVID-19 Outbreak on Exosome Therapeutic Industry Development

Global Market Growth Trends2.1 Industry Trends2.1.1 SWOT Analysis2.1.2 Porters Five Forces Analysis2.2 Potential Market and Growth Potential Analysis2.3 Industry News and Policies by Regions2.3.1 Industry News2.3.2 Industry Policies3 Value Chain of Exosome Therapeutic Market3.1 Value Chain Status3.2 Exosome Therapeutic Manufacturing Cost Structure Analysis3.2.1 Production Process Analysis3.2.2 Manufacturing Cost Structure of Exosome Therapeutic3.2.3 Labor Cost of Exosome Therapeutic3.3 Sales and Marketing Model Analysis3.4 Downstream Major Customer Analysis (by Region)

4 Players Profiles4.1 Player 14.1.1 Player 1 Basic Information4.1.2 Exosome Therapeutic Product Profiles, Application and Specification4.1.3 Player 1 Exosome Therapeutic Market Performance (2015-2020)4.1.4 Player 1 Business Overview4.2 Player 24.2.1 Player 2 Basic Information4.2.2 Exosome Therapeutic Product Profiles, Application and Specification4.2.3 Player 2 Exosome Therapeutic Market Performance (2015-2020)4.2.4 Player 2 Business Overview4.3 Player 34.3.1 Player 3 Basic Information4.3.2 Exosome Therapeutic Product Profiles, Application and Specification4.3.3 Player 3 Exosome Therapeutic Market Performance (2015-2020)4.3.4 Player 3 Business Overview4.4 Player 44.4.1 Player 4 Basic Information4.4.2 Exosome Therapeutic Product Profiles, Application and Specification4.4.3 Player 4 Exosome Therapeutic Market Performance (2015-2020)4.4.4 Player 4 Business Overview4.5 Player 54.5.1 Player 5 Basic Information4.5.2 Exosome Therapeutic Product Profiles, Application and Specification4.5.3 Player 5 Exosome Therapeutic Market Performance (2015-2020)

4.5.4 Player 5 Business Overview5 Global Exosome Therapeutic Market Analysis by Regions5.1 Global Exosome Therapeutic Sales, Revenue and Market Share by Regions5.1.1 Global Exosome Therapeutic Sales by Regions (2015-2020)5.1.2 Global Exosome Therapeutic Revenue by Regions (2015-2020)5.2 North America Exosome Therapeutic Sales and Growth Rate (2015-2020)5.3 Europe Exosome Therapeutic Sales and Growth Rate (2015-2020)5.4 Asia-Pacific Exosome Therapeutic Sales and Growth Rate (2015-2020)5.5 Middle East and Africa Exosome Therapeutic Sales and Growth Rate (2015-2020)5.6 South America Exosome Therapeutic Sales and Growth Rate (2015-2020)

11 Global Exosome Therapeutic Market Segment byTypes12 Global Exosome Therapeutic Market Segment by Applications13 Exosome Therapeutic Market Forecast by Regions (2020-2027)ContinuedComplete Report Is Available| Get Free TOC @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market

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KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. The approval is based on results from the Phase 3 KEYNOTE-177 trial, in which KEYTRUDA significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0004]) compared with chemotherapy, the current standard of care. In the study, treatment with KEYTRUDA also more than doubled median progression-free survival (PFS) compared with chemotherapy (16.5 months [95% CI, 5.4-32.4] versus 8.2 months [95% CI, 6.1-10.2]).

Todays approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on the important findings from KEYNOTE-177 that showed KEYTRUDA monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Our commitment to pursuing biomarker research continues to help us bring new treatments to patients, particularly for those who have few available options.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

This approval was granted less than one month following the submission of a new supplemental Biologics License Application (sBLA), which was reviewed under the FDAs Real-Time Oncology Review (RTOR) pilot program. This review also was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. For this application, a modified Project Orbis was undertaken, and the FDA is collaborating with the Australian Therapeutic Goods Administration, Health Canada and Swissmedic on their ongoing review of the application.

Patients with unresectable or metastatic MSI-H colorectal cancer have historically faced poor outcomes, and until today, chemotherapy-containing regimens were the only FDA-approved first-line treatment options, said Luis A. Diaz, M.D., head of the division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center. In patients who were treated with KEYTRUDA and responded (n=67) in the KEYNOTE-177 trial, 43% of patients experienced a duration of response lasting two years or longer. This approval helps address the unmet need to provide a new monotherapy treatment option for patients.

Data Supporting the Approval

The approval was based on data from KEYNOTE-177 (NCT02563002), a multi-center, randomized, open-label, active-controlled trial that enrolled 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer. Microsatellite instability (MSI) or mismatch repair (MMR) tumor status was determined locally using polymerase chain reaction or immunohistochemistry, respectively. Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible.

Patients were randomized 1:1 to receive KEYTRUDA 200 mg intravenously every three weeks or investigators choice of the following chemotherapy regimens given intravenously every two weeks:

Treatment with KEYTRUDA or chemotherapy continued until Response Evaluation Criteria in Solid Tumors (RECIST) v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. Patients treated with KEYTRUDA without disease progression could be treated for up to 24 months. Assessment of tumor status was performed every nine weeks. Patients randomized to chemotherapy were offered KEYTRUDA at the time of disease progression. The main efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, and overall survival (OS). Additional efficacy outcome measures were objective response rate (ORR) and duration of response (DOR).

Patients were enrolled and randomized to KEYTRUDA (n=153) or chemotherapy (n=154). The baseline characteristics of these 307 patients were: median age of 63 years (range, 24 to 93), 47% age 65 or older; 50% male; 75% White and 16% Asian; 52% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, and 48% had an ECOG PS of 1; and 27% received prior adjuvant or neoadjuvant chemotherapy. Among the 154 patients randomized to receive chemotherapy, 143 received chemotherapy per the protocol. Of these 143 patients, 56% received mFOLFOX6, 44% received FOLFIRI, 70% received bevacizumab plus mFOLFOX6 or FOLFIRI, and 11% received cetuximab plus mFOLFOX6 or FOLFIRI. The median follow-up time was 27.6 months (range, 0.2 to 48.3 months).

In this study, KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0004]) and showed a median PFS of 16.5 months (95% CI, 5.4-32.4) compared with 8.2 months (95% CI, 6.1-10.2) for patients treated with chemotherapy. For PFS, in the KEYTRUDA arm, there were 82 patients (54%) with an event versus 113 patients (73%) in the chemotherapy arm. At the time of the PFS analysis, the OS data were not mature (66% of the required number of events for the OS final analysis). For patients treated with KEYTRUDA, the ORR was 44% (95% CI, 35.8-52.0), with a complete response rate of 11% and a partial response rate of 33%, and for patients treated with chemotherapy, the ORR was 33% (95% CI, 25.8-41.1), with a complete response rate of 4% and a partial response rate of 29%. Median DOR was not reached (range, 2.3+ to 41.4+) with KEYTRUDA versus 10.6 months (range, 2.8 to 37.5+) with chemotherapy. Based on 67 patients with a response in the KEYTRUDA arm and 51 patients with a response in the chemotherapy arm, 75% in the KEYTRUDA arm had a duration of response greater than or equal to 12 months versus 37% in the chemotherapy arm, and 43% in the KEYTRUDA arm had a duration of response greater than or equal to 24 months versus 18% in the chemotherapy arm.

Among the 153 patients with MSI-H or dMMR colorectal cancer treated with KEYTRUDA, the median duration of exposure to KEYTRUDA was 11.1 months (range, 1 day to 30.6 months). Adverse reactions occurring in patients with MSI-H or dMMR colorectal cancer were similar to those occurring in 2,799 patients with melanoma or non-small cell lung cancer treated with KEYTRUDA as a single agent.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High (TMB-H)

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

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FDA Approves Merck's KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer -...

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New York, July 1 : A team of US scientists, led by an Indian-origin researcher revealed that SARS-CoV-2 (coronavirus), the virus behind Covid-19, can infect heart cells in a lab dish.

This suggests it may be possible for heart cells in Covid-19 patients to be directly infected by the virus.

The discovery, published today in the journal Cell Reports Medicine, was made using heart muscle cells that were produced by stem cell technology.

We not only uncovered that these stem cell-derived heart cells are susceptible to infection by a novel coronavirus, but that the virus can also quickly divide within the heart muscle cells, said study researcher Arun Sharma from the Cedars-Sinai Board of Governors Regenerative Medicine Institute in the US.

Even more significant, the infected heart cells showed changes in their ability to beat after 72 hours of infection, Sharma added.Although many COVID-19 patients experience heart problems, the reasons remain unclear. Pre-existing cardiac conditions or inflammation and oxygen deprivation resulting from the infection have all been implicated.

But there has until now been only limited evidence the SARS-CoV-2 virus directly infects the individual muscle cells of the heart.The study also demonstrated human stem cell-derived heart cells infected by SARS-CoV-2 change their gene expression profile.This offers further confirmation the cells can be actively infected by the virus and activate innate cellular defence mechanisms in an effort to help clear-out the virus.

This viral pandemic is predominately defined by respiratory symptoms, but there are also cardiac complications, including arrhythmia, heart failure and viral myocarditis, said study co-author Clive Svendsen.

While this could be the result of massive inflammation in response to the virus, our data suggest that the heart could also be directly affected by the virus in Covid-19, Svendsen added.

Researchers also found that treatment with an ACE2 antibody was able to blunt viral replication on stem cell-derived heart cells, suggesting that the ACE2 receptor could be used by SARS-CoV-2 to enter human heart muscle cells.

By blocking the ACE2 protein with an antibody, the virus is not as easily able to bind to the ACE2 protein, and thus cannot easily enter the cell, said Sharma. This not only helps us understand the mechanisms of how this virus functions, but also suggests therapeutic approaches that could be used as a potential treatment for SARS-CoV-2 infection, he explained.

The study used human induced pluripotent stem cells (iPSCs), a type of stem cell that is created in the lab from a persons blood or skin cells. IPSCs can make any cell type found in the body, each one carrying the DNA of the individual. This work illustrates the power of being able to study human tissue in a dish, the authors wrote.

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Rahul Gandhi to interact with nurses on July 1 - WeForNews

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The bones of the skeletal system serve many important functions for the body, from giving your body support to allowing you to move. They also play an important role in blood cell production and fat storage.

Bone marrow is the spongy or viscous tissue that fills the inside of your bones. There are actually two types of bone marrow:

Read on to learn more about different functions of red and yellow bone marrow as well as the conditions that affect bone marrow.

Red bone marrow is involved in hematopoiesis. This is another name for blood cell production. Hematopoietic stem cells that are found in red bone marrow can develop into a variety of different blood cells, including:

Newly produced blood cells enter your bloodstream through vessels called sinusoids.

As you age, your red bone marrow is gradually replaced with yellow bone marrow. And by adulthood, red bone marrow can be found only in a handful of bones, including the:

Yellow bone marrow is involved in the storage of fats. The fats in yellow bone marrow are stored in cells called adipocytes. This fat can be used as an energy source as needed.

Yellow bone marrow also contains mesenchymal stem cells. These are cells that can develop into bone, fat, cartilage, or muscle cells.

Remember, over time, yellow bone marrow starts to replace red bone marrow. So, most bones in an adult body contain yellow bone marrow.

Bone marrow is crucial for producing blood cells. Therefore, a range of blood-related conditions involve issues with bone marrow.

Many of these conditions affect the numbers of blood cells produced in bone marrow. This causes them to share many common symptoms, including:

Heres a look at some specific conditions involving bone marrow issues.

Leukemia is a type of cancer that can affect both your bone marrow and lymphatic system.

It happens when blood cells get mutations in their DNA. This causes them to grow and divide more rapidly than healthy blood cells. Over time, these cells start to crowd out the healthy cells in your bone marrow.

Leukemia is classified as either acute or chronic, depending on how fast it progresses. Its further broken down by the type of white blood cells it involves.

Myelogenous leukemia involves red blood cells, white blood cells, and platelets. Lymphocytic leukemia involves lymphocytes, a specific type of white blood cell.

Some of the major types of leukemia include:

Theres no clear cause of leukemia, but certain things can increase your risk, including:

Aplastic anemia occurs when bone marrow doesnt produce enough new blood cells. It occurs from damage to the stem cells of bone marrow. This makes it harder from them to grow and develop into new blood cells.

This damage can be either:

Myeloproliferative disorders happen when the stem cells in bone marrow grow abnormally. This can lead to increased numbers of a specific type of blood cell.

There are several types of myeloproliferative disorders, including:

Bone marrow is found in the bones throughout your body. There are two types of bone marrow. Red bone marrow is involved in production of blood cells, while yellow marrow is important for fat storage. As you age, yellow bone marrow replaces red bone marrow.

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Function of Bone Marrow: What Is Bone Marrow, and What ...

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Patients with cancer often incur bone marrow damage, resulting in the destruction of stem cells. Stem cell transplants are used to replenish lost or damaged cells that have been affected by cancer and depending on where the stem cells come from these, the procedure may be a bone marrow transplant (BMT), peripheral blood stem cell transplant, or a cord blood transplant.

Typically, in a stem cell transplant, physicians administer high doses of chemotherapy, occasionally in conjunction with radiation therapy, to kill all cancer cells. This is known as myeloablative therapy.

Here are the two main types of transplants, as outline by the American Cancer Society:

In an autologous stem cell transplant, the patient serves as their own donor. Auto means self, therefore this procedure means harvesting your own stem cells from either your blood or bone marrow, then freezing them for preservation. Following high-dose chemo and radiation therapy, the frozen cells are thawed and returned to the (self) donor. Autologous transplants are sometimes used for testicular cancer and brain tumors, but are mainly utilized to treat leukemia, lymphoma, and multiple myeloma. For the latter, autologous stem cell procedures offers patients a chance for achieving sustained remission. One advantage of autologous stem cell transplant is that youre getting your own cells back. When you getyour own stem cells back, you dont have to worry about them (called the engrafted cells or the graft) being rejected by your body, says the American Cancer Society.

Despite the benefits, as with all procedures, there are risks involved, including graft failure which occurs when the transplanted stem cells dont go into bone marrow fail to properly produce blood cells. A possible disadvantage of an autologous transplant is that cancer cells might be collected along with the stem cells and then later put back into your body, the ACS says, adding that another disadvantage of a autologous stem cell transplants is that your immune system is the same as it was before your transplant. This means the cancer cells were able to escape attack from your immune system before, and may be able to do so again.

But how exactly do physicians prevent any residual cancer cells from being transplanted with healthy cells? In a process known as purging, stem cells are treated before being infused back into the patients blood. Although purging carries its benefits, a potential downside, according to the ACS, is that normal cells may be lost during this process, which in turn could lead to unsafe levels of white blood cells as your body takes longer to produce normal blood cells. Cancer centers will also sometimes use in vivopurging, which involves not treating the stem cells, and instead administering anti-cancer drugs to patients post-transplant. The ACS notes, however, that the need to remove cancer cells from transplanted stem cells or transplant patients and the best way to do it continues to be researched.

Whereas autologous procedures infuse stem cells from your own body, allogeneic stem cell transplants use cells from a donor with a very similar tissue type (in many cases a relative, usually a sibling). In cases where the ideal donor is not a relative, physicians may opt to perform a matched unrelated donor (MUD) transplant, which as the ACS notes, are usually riskier than those with a relative who is a good match.

Allogeneic transplants comprise of the same process as autologous stem cell transplants where stem cells are harvested, frozen, and subsequently thawed and put back following high-dose chemo and/or radiation therapy. In some cases, the procedures involve the infusion of blood extracted from the placenta and umbilical cord of a newborn because the cord contains a high number of stem cells that quickly multiple. By 2017, an estimated 700,000 units (batches) of cord blood had been donated for public use. And, even more have been collected for private use. In some studies, the risk of a cancer not going away or coming back after a cord blood transplant was less than after an unrelated donor transplant, writes the ACS.

A benefit of an allogeneic transplant is that donor stem cells create their own immune cells, which may eliminate any residual cancer cells that remain after high-dose treatment, which is known as the graft-versus-cancer effect. Moreover, because the donor stem cells are free of cancer, donors can be asked to donate stem cells or white blood cells multiple times.

As with autologous stem cell procedures, this donor dependent transplant also carries risk. The transplant, or graft, might be destroyed by the patients body before reaching the bone marrow. Allogeneic stem cell transplants also augment the risk of graft-versus-host-disease, where cells from the donor attack healthy cells in the recipients body. Furthermore, despite the healthy cells being tested before transplant, allogeneic procedures still carry a certain risk of infections because, as the ACS writes, your immune system is held in check (suppressed) by medicines calledimmunosuppressivedrugs. Such infections can cause serious problems and even death.

Because theres a plethora of human leukocyte antigen (HLA) combinations, which are inherited from both parents, finding an exact donor match can often be an arduous task. The search usually starts at siblings, and theres a 25% chance of a sibling being a perfect match. In the event that a sibling does not match, the search moves onto extended family (and parents) who are less likely to match.

The ACS writes: As unlikely as it seems, its possible to find a good match with a stranger. To help with this process, the team will use transplant registries, like those listed here. Registries serve as matchmakers between patients and volunteer donors. They can search for and access millions of possible donors and hundreds of thousands of cord blood units.

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The Two Types of Stem Cell Transplants for Cancer Treatment - DocWire News

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Stem cell characterization is the study of tissue-specific differentiation. Thera are various type of stem cell such as embryonic stem cell, epithelial stem cell and others. Further, various techniques are used to characterized stem cells such as immunological techniques, used for depiction of different population of stem cells. These techniques are generally based on immunochemistry using staining technique or florescent microscopy. Besides, stem cells characterization and analysis tools are used against target chronic diseases. In 2014, the San Diego (UCSD) Health System and Sanford Stem Cell Clinical Center at the University of California announced the launch of a clinical trial, in order to assess the safety of neural stem cellbased therapy in patients with chronic spinal cord injury.

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The factors driving the growth of stem cell characterization and analysis tools market due to increasing chronic disorders such as cancer, a diabetes and others. In addition, increasing awareness about among people about the therapeutic potency of stem cells characterization in the management of effective diseases is anticipated to increase the demand for stem cell characterization and analysis tools. Further, there are various technologies such as flow cytometry which is used to characterize the cell surface profiling of human-bone marrow and other related purposes are expected to increase the growth of stem cell characterization and analysis tools market. In addition, increasing investment by private and public organization for research activities are likely to supplement the market growth in near future.

On the other hand, the unclear guidelines and the technical limitation for the development of the product are expected to hamper the growth of stem cell characterization and analysis tools market.

Rapid increase in corona virus all around the world is expected to hamper the growth of stem cell characterization and analysis tools market. The virus outburst has become one of the threats to the global economy and financial markets. The impact has made immense decrease in revenue generation in the field of all healthcare industry growth for the market in terms of compatibility and it has led in huge financial losses and human life which has hit very hard to the core of developing as well as emerging economies in healthcare sector. It further anticipated that such gloomy epidemiological pandemic environment is going to remain in next for at least some months, and this is going to also affect the life-science market which also include the market of stem cell characterization and analysis tools market.

Based on the Products and Service Type, stem cell characterization and analysis tools market are segmented into:

Based on the Technology, stem cell characterization and analysis tools market are segmented into:

Based on the Applications, stem cell characterization and analysis tools market are segmented into:

Based on the End User, stem cell characterization and analysis tools market are segmented into:

Based on the segmentation, human embryonic stem cell is expected to dominate the market due to their indefinite life span and higher totipotency as compared to other stem cells. Further, on the basis of technology segmentations, cell production is anticipated to increase the demand for stem cell characterization and analysis tools due to their emerging applications for stem cells in drug testing in the management of the effective diseases. Furthermore, on the basis of application segmentations, oncology is expected to show significant growth rate due to increase in the number of pipelines products for the treatment of cancers or tumors. Based on the end user, pharmaceutical and biotechnology companies are expected to dominate the market due to rising global awareness about the therapeutics research activities.

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Geographically, the global stem cell characterization and analysis tools market is segmented into regions such as Latin America, Europe, North America, South Asia, East Asia Middle East & Africa and Oceania. North America is projected to emerge as prominent market in the global stem cell characterization and analysis tools market due to growing cases of target chronic diseases and increasing investments for research activities. Europe is the second leading region to dominate the market due to technological advancement and also surge in therapeutic activities, funded by government across the world. Asia-pacific is likely to witness maximum growth in near future due to increasing disposable income and with the development of infrastructure.

Some of the major key players competing in the global stem cell characterization and analysis tools market are Osiris Therapeutics, Inc., Caladrius Biosciences, Inc., U.S. Stem Cell, Inc., Astellas Pharma Inc., TEMCELL Technologies Inc., BioTime Inc., Cellular Engineering Technologies Inc., Cytori Therapeutics, Inc., and BrainStorm Cell Therapeutics Inc.

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Impact of COVID 19 pandemic on Stem Cell Characterization and Analysis Tools Market Structure and Its Segmentation - 3rd Watch News

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When you compare pictures of presidents who do not alter their hair color, they all leave office considerably grayer than when they started, which some link to the stress of the office.

Marie Antoinette syndrome is a condition in which scalp hair suddenly turns white. The name comes from the story that Marie Antoinettes hair turned white the night before she was to face the guillotine during the French Revolution.

The same thing happened to survivors of atomic bomb attacks during World War II. It has long been thought that genetics, aging and stress all contribute to developing gray hair.

New research has revealed how stress contributes to graying.

On average, humans have 100,000 hair follicles in their scalp, which produce hairs of one color or another. Hair color is determined by the types of melanin produced by cells called melanocytes. Melanocytes grow from melanocyte stem cells (MeSCs) inside the hair follicle.

With age, the number of MeSCs declines, leading to hair graying in stages from the occasional gray one, to salt and pepper, to gray and then white when all the MeSCs are gone. But how stress leads to gray hair has been a mystery.

It had been thought that stress-induced graying involved hormones such as corticosterone or autoimmune reactions. Scientists did experiments in mice and found that neither of those was the cause.

However, when they blocked the receptor for the fight-or-flight hormone, noradrenaline, they stopped hair graying in response to stress in mice. Finally, they had a clue.

The main source of noradrenaline is the adrenal glands. However, when the scientists removed the adrenal glands in mice, their hair still turned gray in response to stress. Another source of the hormone is the sympathetic nervous system (SNS), which is part of the autonomic nervous system that works to regulate many functions and parts of the body without us thinking about it.

The SNS controls the fight-or-flight response to stress to prepare the whole body for physical activity. SNS nerves and MeSCs are close together in the hair follicle, and blocking those SNS nerves prevented the hairs from turning gray in response to stress. Conversely, when the SNS nerves were over-activated, the mice went gray even without stress.

Normally, MeSCs are dormant unless hair is regrowing. In response to extreme stress, MeSCs reproduce and mature into melanocytes quickly. Large numbers of melanocytes then migrate from the follicle, leaving no MeSCs in the follicles and no melanocytes to provide the pigments that give hair its color. Once they are all gone, hair will never be its original color again.

This brings up the added question about other effects of stress, including a decline in immunity and the ability to fight off infections.

The SNS system also stimulates stem cells in the bone marrow to mature into the blood cells required to protect us from infections. Nearly every organ in the body contains stem cells, and stress could have an impact on those as well.

Medical Discovery News is hosted by professors Norbert Herzog at Quinnipiac University, and David Niesel of the University of Texas Medical Branch. Learn more at http://www.medicaldiscoverynews.com.

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How stress contributes to the graying of hair - Galveston County Daily News

Recommendation and review posted by Bethany Smith

- Partnership leverages Boehringer Ingelheims oncology expertise to lead trilaciclib SCLC launch sales engagements- G1 to retain full development and commercialization rights and book revenue for trilaciclib-New Drug Application (NDA) for trilaciclib submitted in June 2020

RESEARCH TRIANGLE PARK, N.C. and RIDGEFIELD, Conn., June 30, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX) and Boehringer Ingelheim today announced that the companies have entered into a co-promotion agreement for trilaciclib in the United States and Puerto Rico. Under the terms of the three-year agreement, G1 and Boehringer Ingelheim will collaborate on the commercialization of trilaciclib for its first potential indication in small cell lung cancer (SCLC), with the Boehringer Ingelheim oncology commercial team, well-established in lung cancer, leading sales force engagement initiatives. Discovered and developed by G1, trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy.

We believe that trilaciclib has the potential to benefit patients with cancer being treated with chemotherapy across a broad range of solid tumors, said Mark Velleca, M.D., Ph.D., Chief Executive Officer of G1. Our clinical trials of trilaciclib in small cell lung cancer have demonstrated significant myelopreservation benefits, and we are excited to collaborate with Boehringer Ingelheims experienced commercial oncology team to bring this innovative therapy to patients with SCLC. In addition, this capital efficient launch structure provides us with the ability to make investments in a robust development program to assess trilaciclib in other solid tumors, including colorectal cancer and breast cancer.

Under the terms of the agreement, G1 will book revenue in the United States and Puerto Rico and retain global development and commercialization rights to trilaciclib. In the U.S. and Puerto Rico, G1 will lead marketing, market access and medical engagement initiatives; Boehringer Ingelheim will lead sales force engagements. G1 will make initial payments to Boehringer Ingelheim to cover start-up expenses and pre-approval initiatives to support a successful commercial launch. G1 will pay a promotion fee of a mid-twenties percentage of net sales in the first year of commercialization, which decreases to a low double-digit/high single-digit percentage in the second and third years of commercialization, respectively (subject to certain adjustments for sales above pre-specified levels to reward out-performance). There are no payments due by either party beyond the expiration of the three-year term of the agreement. The agreement does not extend to additional indications that G1 may pursue for trilaciclib.

Boehringer Ingelheims commitment to transform treatment expectations for the oncology community extends beyond research and drives us to explore innovative solutions for patients. We are pleased to be collaborating with G1 Therapeutics and applying our commercial strengths focused on lung cancer to support a new therapy for patients with clear synergies across customer audiences, said Kelli Moran, Senior Vice President, Specialty Care, Boehringer Ingelheim. This strategic agreement builds on Boehringer Ingelheims achievements in oncology and contributes to our long-term vision to give patients new hopeby taking cancer on.

G1 received Breakthrough Therapy Designation for trilaciclib from the U.S. Food and Drug Administration (FDA) in 2019 and submitted a New Drug Application (NDA) in June 2020. More than 25,000 people in the U.S. and Puerto Rico are diagnosed with SCLC each year. Approximately 90% of SCLC patients receive first-line chemotherapy treatment, and approximately 60% of those patients receive subsequent second-line chemotherapy treatment. Chemotherapy is an effective and important weapon against cancer. However,chemotherapy does not differentiate between healthy cells and cancer cells and kills both. One of the most common side effects of chemotherapy is myelosuppression the result of damage to stem cells in the bone marrow that produce white blood cells, red blood cells and platelets. Myelosuppression often requires the administration of rescue interventions such as growth factors and blood or platelet transfusions, and may also result in chemotherapy dose delays and reductions. Immune cell damage may decrease the ability of the immune system to fight the cancer, as well as infection. Trilaciclib has the potential to be the first proactively administered myelopreservation therapy that can make chemotherapy safer and improve the patient experience.

Additional information regarding this agreement is disclosed in a Current Report on Form 8-K filed by G1 with the U.S. Securities and Exchange Commission (available here).

About TrilaciclibTrilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Trilaciclib has received Breakthrough Therapy Designation based on positive myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patients with small cell lung cancer (SCLC). In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered prior to chemotherapy. In June 2020, G1 submitted a New Drug Application (NDA) for trilaciclib for myelopreservation in SCLC and began a study in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL. The company expects to initiate a Phase 3 trial in colorectal cancer in the fourth quarter of 2020.

About G1 TherapeuticsG1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class FDA-designated Breakthrough Therapy designed to improve outcomes for patients being treated with chemotherapy. Rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit http://www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

About Boehringer Ingelheim in OncologyCancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hopeby taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science.Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approachesto help combat many cancers.

About Boehringer IngelheimMaking new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities.Please visit http://www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives. For more information, please visit http://www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

G1 Therapeutics Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in theU.S. for trilaciclib in SCLC, trilaciclibs possibility to improve patient outcomes across multiple indications, rintodestrants potential to be best-in-class oral SERD, lerociclibs differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors and the impact of pandemics such as COVID-19 (coronavirus), and are based on the companys expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the companys actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the companys filings with theU.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the companys ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the companys initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:Jeff MacdonaldG1 Therapeutics, Inc.Senior Director, Investor Relations & Corporate Communications919-907-1944jmacdonald@g1therapeutics.comSusan HolzBoehringer IngelheimDirector, Public Relations203-798-4265Susan.holz@boehringer-ingelheim.com

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G1 Therapeutics and Boehringer Ingelheim Announce Co-Promotion Agreement for Trilaciclib in Small Cell Lung Cancer in the United States and Puerto...

Recommendation and review posted by Bethany Smith

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The complete paper describes an operators experience in confirming glass fiber-reinforced epoxy (GRE) as an effective alternative to high-grade corrosion-resistant alloys (CRA) to extend tubing life in high-velocity gas wells. Laboratory testing and applications in several fields, both on and offshore, and in oil-production and water-injection wells and surface-gathering lines, demonstrate that, when used within the operating limits, GRE can extend tubing life and provide life-cycle cost savings.

The material has been intensively tested in the past to determine characteristics and capabilities. Mechanical properties, fatigue resistance, chemical compatibilities, connection properties, and abrasion trials have been proved by specific laboratory tests and field trials, demonstrating that GRE can be applied inside production tubing strings. API RP15CLT, first issued in 2007, provides guidelines for the design, manufacture, qualification, and application of composite-lined carbon-steel downhole tubing in the handling and transport of multiphase fluids, hydrocarbon gases, hydrocarbon liquids, and water.

Carbon steel guarantees the systems mechanical resistance, and the internal GRE liner ensures corrosion resistance. GRE provides outstanding corrosion resistance, even in very aggressive environments.

For oil-well applications, the system consists of a GRE resin composite liner inserted inside a low-alloy carbon steel tubing with a cement grout (Fig. 1). The grout transfers pressure directly to the steel tubing even if there is little or no bonding between liner, grout, and metal.

The end of the liner is protected from mechanical damage by a GRE end cap (flare) or a T-end flange. A polymeric corrosion barrier ring usually provides the continuity of the corrosion barrier across the coupling between two adjacent flares. The lining is lightweight, adding no more than 13% of the weight of the steel pipes and eliminating the need for additional lifting equipment.

The operator has been involved in the development of deepwater gas fields with high production rates and sour environments. On the basis of corrosion assessments performed on actual field conditions, CRA (high nickel content) material was selected as most suitable for the production tubing string. Following positive experiences with the installation of GRE, the company decided to evaluate its performance in potentially high-erosion conditions, aiming to find an alternative material to high-grade CRA for installation in high-velocity gas wells that would reduce cost and delivery time. The GRE liner was selected as a cost-effective alternative to high-alloy materials starting from 2005, when GRE was successful in reducing onshore workover costs and extending the life of carbon-steel tubing in oil producer wells with high carbon dioxide and water cut, to recent installations offshore Norway in water injection wells with highly corrosive injection fluids.

The complete paper summarizes the testing and application range of GRE in corrosive environments and, through collaboration with the Polytechnic University of Milan, high-flow, direct-impact erosion testing using a continuous flow loop and a nozzle-directed solids-impingement-testing system.

The direct-impact test confirmed that GRE shows a high resistance to erosion at high velocities and solids loadings. As a reference, similar tests were performed on nickel alloy 625 material (same sand size, jet velocity, time and 90 impact angle), and provided values very close to those obtained for the GRE composites. Results could be considered comparable to those obtained on the experimental analysis performed by the Polytechnic University of Milan.

Visual inspection of the internal surface of the GRE coating following the straight pipe flow-loop erosion revealed no sign of erosion. Similarly, the thickness of the GRE coating remained unchanged, further confirming the absence of measurable or detectable mass removal.

The GRE liner has been successfully applied in several fields, onshore and offshore, as tubing corrosion protection in oil-production wells, water-injection wells, and surface flowlines. The complete paper summarizes field applications in north Africa, northeast Africa, the Middle East, and the Barents Sea (Fig. 2). The feedback from the field cases confirmed that, when used within the operating limits, the GRE material represents a valid option for life extension and lifecycle cost savings.

Economic analyses comparing GRE liners with carbon steel and CRA for water-injection and oil-production wells in onshore and offshore conditions reveal that GRE cost is more than double that of the tubing in bare carbon steel. However, alternative CRAs, which have sometimes been considered, have proved more expensive than the one used in this paper.

Original post:
Glass-Reinforced Epoxy Effective Alternative to Alloys in Gas Wells - Journal of Petroleum Technology

Recommendation and review posted by Bethany Smith

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Black Cumin Seed OilMarket which would mention How the Covid-19 is Affecting the Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Key Regions and Proposal for Black Cumin Seed Oil Market Players to battle Covid-19 Impact.

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Top Leading players covered in the Black Cumin Seed Oil market report: Henry Lamotte OILS GmbH, FLAVEX Naturextrakte GmbH, Henry Lamotte Oils GmbH, Kerfoot Group, Earthoil Plantations, Life Extension, Nuverus, Omega Pharma, BioPraep and More

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Regions Covered in the Global Black Cumin Seed Oil Market: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

Years Considered to Estimate the Black Cumin Seed Oil Market Size:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year: 2020-2026

Highlights of the Report: Accurate market size and CAGR forecasts for the period 2019-2026 Identification and in-depth assessment of growth opportunities in key segments and regions Detailed company profiling of top players of the global Black Cumin Seed Oil market Exhaustive research on innovation and other trends of the global Black Cumin Seed Oil market Reliable industry value chain and supply chain analysis Comprehensive analysis of important growth drivers, restraints, challenges, and growth prospects

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Black Cumin Seed Oil Market 2026 Expected to reach Highest CAGR including major key players Henry Lamotte OILS GmbH, FLAVEX Naturextrakte GmbH, Henry...

Recommendation and review posted by Bethany Smith

Analytical Research has added a new report to their increasing litany of reports titled Appetite Control and Suppressants Market Report. The new study encompasses valuable insights using a variety of graphs, tables and figures that explores opportunities, trends and drivers surrounding the Appetite Control and Suppressants industry.

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By Market Players:Natural Factors, NOW Foods, Bio Sense, Hydroxycut, Life Extension, Lipozene, ASquared Nutrition, Baetea, BeLive, Better Mornings, BioGanix, BioSchwartz, BRL Sports Nutrition, Dr. Joeys, EBYSU, Health Plus Prime, Healthy Delights, iPro Organic Supplements

By ApplicationNatural, Vegetarian, Gluten-Free, Organic, Vegan

By TypeCapsules, Tablets, Powders, Caplets, Drops

The prime objective of this report is to help the user understand the market in terms of its definition, segmentation, market potential, influential trends, and the challenges that the market is facing. Deep researches and analysis were done during the preparation of the report. The readers will find this report very helpful in understanding the market in depth. The data and the information regarding the market are taken from reliable sources such as websites, annual reports of the companies, journals, and others and were checked and validated by the industry experts. The facts and data are represented in the report using diagrams, graphs, pie charts, and other pictorial representations. This enhances the visual representation and also helps in understanding the facts much better.

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Points Covered in The Report:The points that are discussed within the report are the major market players that are involved in the market such as manufacturers, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. The historical data from 2014 to 2019 and forecast data from 2020 to 2025.The growth factors of the market is discussed in detail wherein the different end users of the market are explained in detail.Data and information by manufacturer, by region, by type, by application and etc, and custom research can be added according to specific requirements.The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

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Table of Content

Chapter One: Industry Overview

Chapter Two: Major Segmentation (Classification, Application and etc.) Analysis

Chapter Three: Production Market Analysis

Chapter Four: Sales Market Analysis

Chapter Five: Consumption Market Analysis

Chapter Six: Production, Sales and Consumption Market Comparison Analysis

Chapter Seven: Major Manufacturers Production and Sales Market Comparison Analysis

Chapter Eight: Competition Analysis by Players

Chapter Nine: Marketing Channel Analysis

Chapter Ten: New Project Investment Feasibility Analysis

Chapter Eleven: Manufacturing Cost Analysis

Chapter Twelve: Industrial Chain, Sourcing Strategy and Downstream Buyers

List of Table and Figure

Figure Product PictureTable 2014-2019 Major Types Market Sales Volume And Market ShareFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateTable 2014-2019 Capacity, Production, Capacity Utilization Rate, Ex-Factory Price, Revenue, Cost, Gross And Gross MarginFigure 2014-2019 Capacity, Production And Growth RateFigure 2014-2019 Capacity, Production And Capacity Utilization Rate continued

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Appetite Control and Suppressants Market 2020 Size, Share, Business Overview, Trends and Forecast to 2025 - Cole of Duty

Recommendation and review posted by Bethany Smith

Recent work has called into question the reality of the rare male mating advantage, pointing out that it could be a statistical artifact of marking flies for behavioral observation or of experimental bias in collecting males. We designed an experiment to test for rare male mating advantage that avoids these sources of bias. Large numbers of males of three Drosophila pseudoobscura karyotypes were allowed to mate with females of one karyotype in population cages. The females were then isolated before multiple mating occurred and their progeny used to diagnose the males that mated them. Populations were studied at five sets of male karyotypic frequencies. The mating success of the male homokaryotypes ST/ST and CH/CH, relative to that of the heterokaryotype ST/CH, was frequency dependent. Both ST/ST and CH/CH males displayed a statistically significant mating advantage at low frequency by comparision with their mating success in the midrange of karyotypic frequencies. Both male homokaryotypes also showed a significantly greater mating success at high homokaryotypic frequency than at intermediate frequencies, which is the same as saying that the heterokaryotype not only failed to show a rare male advantage but actually suffered a mating disadvantage at low frequency. We conclude that rare male mating advantage is not always an experimental or methodological artifact but does occur in laboratory populations of D. pseudoobscura. It may occur for some genotypes and not for others, however, and it may be only one of several forms of frequency-dependent mating behavior operating in a population.

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A TEST FOR RARE MALE MATING ADVANTAGE WITH ... - genetics.org

Recommendation and review posted by Bethany Smith

NEW HAVEN, Conn.--(BUSINESS WIRE)--While infertility, or the inability to conceive after one year of trying used to be a womans problem, there is now a better understanding of the important role men play in conceiving. In at least half of all infertility cases, men are either the contributing or leading cause. To help couples better understand common fertility issues, Mary Jane Minkin, MD, OB/GYN, founder of MadameOvary.com, sheds light on male fertility factors and how men can be proactive in improving their fertility.

The well-known advice for couples trying to conceive are centered around the womans fertile window or when she should start to abstain from alcohol, says Mary Jane Minkin, MD, Clinical Professor of Obstetrics & Gynecology at Yale University. However, it takes two to tango, and couples should be aware of both female and male fertility issues to improve their odds of conceiving. As science and research continues to move forward in treating infertility, realize that there are ways to address male fertility, and that 90% of infertility cases are treatable with current medical therapies.

Dr. Minkin suggests the below tips to help men be proactive when it comes to their fertility:

The trying to conceive journey looks different for every couple, adds Minkin. Both partners should remember to be proactive about their health, modify their lifestyle accordingly, and if struggling to conceive, be supportive of one another and prioritize communication.

See original here:
Men's Health Month: Mary Jane Minkin, M.D., OB/GYN Shares 5 Proactive Fertility Tips for Men When Trying to Conceive - Business Wire

Recommendation and review posted by Bethany Smith

VICE does not imply that Prince William has excessive sex hormones or COVID-19. Image viaSteve Parsons / POOL / AFP (cropped)

Towards the end of May, a study published by a team of Spanish researchers and dermatologists found that out of a sample of 122 male COVID-19 patients admitted to hospitals in Madrid, 79 percent were baldabout double the standard population frequency.

Four weeks later, another paper published in the Journal of Cosmetic Dermatology found bald men were similarly overrepresented among COVID-19 hospital admissions.

Both studies were small, and neither of them definitively confirmed the correlation between male pattern hair loss and susceptibility to coronavirus. But together they launched a shockwave of articles around the world proclaiming scientists fears that follicly challenged men might be at greater risk of catching, and dying from, COVID-19.

According to Jenny Graves, Professor of Genetics and Vice Chancellor's Fellow at Melbournes La Trobe University, the science more or less checks out: there may well be a plausible biological explanation for the apparent link between baldness and vulnerability to COVID. And it's got to do with sex hormones.

In a piece published for The Conversation, Dr Graves points out that male pattern hair loss is typically linked to a family of sex hormones called androgens. Androgens are commonly referred to as male hormones for the way in which they regulate the development of male characteristics, such as the development of sexual organs, the growth of the prostate, and balding.

High levels of androgen are strongly associated with hair loss. But studies suggest that these hormones might also play an important role in mediating the entry of SARS-CoV-2 (the virus that causes COVID-19) into cellsthus increasing the risk of severe infection and death.

Hence the theory that the more male hormones present in a persons body, the easier it is for the coronavirus to get in and take hold. As Dr Graves indicates, this could be one reason why men in general appear to be at greater risk of severe infection than women.

More research is needed to firm this upand Dr Graves hastens to point out that larger samples which control for age and other conditions, for one, would go a long way towards confirming whether the link between alopecia-causing androgens and COVID-19 is as significant as it appears. If it is, though, she also suggests that it might be worth looking at anti-androgens, as well as androgen deprivation therapy (ADT), as a way to potentially treat and prevent the disease.

Anti-androgens are a class of testosterone-blocking drugs that effectively prevent androgens from carrying out their biological effects in the body. Theyre already used to treat a range of conditions, including hair loss, overly high sex drive, problematic sexual urges, and prostate cancer. The idea, essentially, is this: if the hormones that cause balding also increase COVID-19 vulnerability, maybe the medicines we have to prevent balding could be used to protect against COVID-19.

Scientists are already exploring this possibility. In a study that looked at a sample of men hospitalised with COVID-19 in Italy, researchers observed that the rate of infection was four times lower in prostate cancer patients on ADT than in untreated cancer patients.

Our data suggest that cancer patients have an increased risk of SARS-CoV-2 infections compared with non-cancer patients. However, prostate cancer patients receiving ADT appear to be partially protected from SARS-CoV-2 infections, they concluded.

Results like this give credence to the idea that similar anti-androgen regimes and therapies could be used not only as treatment, but also prevention, of COVID-19.

Perhaps a single dose given to someone who tests positive to SARS-CoV-2, or has just been exposed, would suffice to lower the chance of the virus taking hold, Dr Graves speculates. But we need research to confirm this.

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Excessive Sex Hormones Could Be Making Bald Men More Vulnerable to COVID-19 - VICE

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Which guy doesn't desire an aesthetic physique? For achieving this, a lot of dedication, discipline and will power is required. Most importantly, patience and a 'never say die' attitude is essential when you are aiming for the desired body.Let's take a look at five exercises for V-Cut absas we observe Men's Health Week 2020.Mens Health Week 2020: From Cleaning Foot to Keeping Your Armpit Fresh, Here Are Five Personal Hygiene Habits Every Male Should Follow.

V-Cut abs, also known as the adonis belt, sex lines, v cuts or v abs are the muscles on the lower sides of the abdomen that form a V-shape. V-Cut abs are aesthetically pleasing. In order to achieve this v-shape on abdominal muscles, one has to do rigorous workout and mainly concentrate on their diet. Apart from performing regular core exercises, it is also necessary to focus on deadlifts, squats, overhead press along with other compound exercises. It must also be noted that genetics play an important role in achieving V-Cut abs. Some people may easily develop this physique, however, there are some who have thicker skin around their abdomen or even have uneven abs, and might find it difficult to get that v-shape. Nevertheless, following below exercises with a good diet can help you achieve a strong core and perfectly well-defined rectus abdominis muscles.Men's Health Week 2020: From Cardiovascular Diseases to Erectile Dysfunction, Common Health Conditions Males Can Develop with Age!

Five Exercises For V-Cut Abs

1. Hanging Leg Raises

It is necessary to work on burning fat around lower abdominal muscles to get those v-cut abs. Performing three to four sets of hanging leg raises of 10-12 reps perfectly can help in removing lower belly fat.

2. Reverse Crunches

This exercise works not only on lower abdominal muscles but also on the upper and middle abs. It has to be performed smoothly without putting any stress on the neck to avoid injury. Reverse crunches should be performed in four sets of fifteen reps each.

3. Mountain Climber

This exercise is also included in high-intensity interval training. If performed with pace, it shoots the heart rate and effectively helps in fat loss.

4. Leg Flutters

This exercise might look simple,but it effectively works on lower abdominal muscles. Leg flutters should be regularly included in your core training for achieving V-shape abs.

5. Seated Leg Tucks

Seated leg tucks work on obliques, middle abs, upper abs and also on the lower abs. Stability and good balance are required while performing this exercise.

In order to achieve V-Cut abs, make sure that you include fresh green vegetables in your diet regularly and eat food cooked in very less oil. Cold drinks, desserts, bakery products and refined flour should be a strict no if you are aiming for those six-pack or eight-pack abs. Even if you don't reach V-Cut shape abs, you shouldn't get disheartened as these routines will at least help in reducing your visceral fat percentage that can significantly reduce the risk of heart diseases. For better results, it is recommended to get trained under a fitness trainer and get a proper diet plan from a dietician.

(The above story first appeared on LatestLY on Jul 01, 2020 09:36 AM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).

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Mens Health: From Hanging Leg Raises to Reverse Crunches; Here Are 5 Exercises to Get V-Cut Abs (Watch - LatestLY

Recommendation and review posted by Bethany Smith

NEW YORK, July 1, 2020 /PRNewswire/ -- This report is 80% complete and can be delivered within three working days post order confirmation and will include the latest impact analysis of Covid-19 in 2020 and forecast.

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Global Autoimmune Disease Diagnostics Market By Type (Systemic, Organ-Specific), By Sex (Male, Female), By Age (0-15, 15-44, 44+), By Factors (Diet, Genetics, Environmental agents), By Diagnosis (Antinuclear Antibody Test, Autoantibody Test, Others), By Types of Treatment (Nonsteroidal Anti-Inflammatory Drugs, Immune-Suppressing Drugs, Others), By Product (Kits and assays, Reagents), By End-User (Hospital, Clinics, Others), By Region, Competition, Forecast & Opportunities, 2025

Global autoimmune disease diagnostics market size was valued at USD4 billion in 2019 and projected to grow at a formidable CAGR during the forecast period.The key factor driving the growth of autoimmune disease diagnostics market is surging investment in healthcare sector.

Additionally, growing cases of autoimmune diseases is further anticipated to bode well for the growth of autoimmune disease diagnostics market across the globe in the coming years.Moreover, increasing government support in terms of providing funds is projected to bolster the market growth through 2025.

Moreover, growing implementation of lab automation technologies in developing nations such as U.S. and Europe are further aiding the market growth. The global autoimmune disease diagnostics market is segmented based on type, sex, age, factors, diagnosis, types of treatment, product, end-user, region and company.Based on product, the market can be segmented into kits and assays, reagents and instruments.

Out of which, the kits and assays segment dominated the market in terms of largest market size until 2019 and is further anticipated to maintain its leading position during the forecast period as well.This growth can be accredited to increasing adoption of kits and assays in hospitals and clinical laboratories.

Moreover, increasing prevalence of autoimmune diseases coupled with growing requirement for fast results, is expected to boost the growth of the segment in the upcoming years. Major players operating in the autoimmune disease diagnostics market include Siemens, Abbott, Bio-Rad Laboratories, Pfizer, Johnson and Johnson, Grifols, Trinity Biotech, Thermo Fisher Scientific, Inova Diagnostics, Hycor Biomedical, Euroimmun, Protagen, Roche, Quest Diagnostics, Hemagen Diagnostics, Aesku Diagnostics, Sanofi, Sun Pharmaceutical Industries Ltd., Eli Lilly, Bayer, etc. The companies operating in autoimmune disease diagnostics market across the globe are focussing more towards the expanding their share in the market. For instance, these key players are making organic strategies such as mergers and acquisitions, among others in order to survive the highly competitive industry.

Years considered for this report:

Historical Years: 2015-2018 Base Year: 2019 Estimated Year: 2020 Forecast Period: 20212025

Objective of the Study:

To analyse and forecast the market size of global autoimmune disease diagnostics market. To classify and forecast global autoimmune disease diagnostics market based on type, sex, age, factors, diagnosis, types of treatment, product, end-user, company and regional distribution. To identify drivers and challenges for global autoimmune disease diagnostics market. To examine competitive developments such as expansions, new product launches, mergers & acquisitions, etc., in global autoimmune disease diagnostics market. To conduct pricing analysis for global autoimmune disease diagnostics market. To identify and analyse the profile of leading players operating in global autoimmune disease diagnostics market. The analyst performed both primary as well as exhaustive secondary research for this study.Initially, the analyst sourced a list of companies across the globe.

Subsequently, the analyst conducted primary research surveys with the identified companies.While interviewing, the respondents were also enquired about their competitors.

Through this technique, the analyst could include the companies which could not be identified due to the limitations of secondary research. The analyst examined the new products, distribution channels and presence of all major players across the globe. The analyst calculated the market size of global autoimmune disease diagnostics market using a bottom-up approach, wherein data for various end-user segments was recorded and forecast for the future years. The analyst sourced these values from the industry experts and company representatives and externally validated through analyzing historical data of these product types and applications for getting an appropriate, overall market size.

Various secondary sources such as company websites, news articles, press releases, company annual reports, investor presentations and financial reports were also studied by the analyst.

Key Target Audience:

Autoimmune disease diagnostics companies and other stakeholders. Government bodies such as regulating authorities and policy makers Organizations, forums and alliances related to autoimmune disease diagnostics Market research and consulting firms The study is useful in providing answers to several critical questions that are important for the industry stakeholders such as companies and partners, end users, etc., besides allowing them in strategizing investments and capitalizing on market opportunities.

Report Scope:

In this report, global autoimmune disease diagnostics market has been segmented into following categories, in addition to the industry trends which have also been detailed below: Market, By Type: o Systemic o Organ-specific Market, By Sex: o Male o Female Market, By Age: o 0-15 o 15-44 o 44+ Market, By Factors: o Diet o Genetics o Environmental Agents Market, By Diagnosis: o Antinuclear Antibody Test o Autoantibody Test o CBC o Comprehensive Metabolic Panel o C-reactive Protein o Erythrocyte Sedimentation Rate o Urinalysis o Imaging Test o Biopsy Market, By Types of Treatment: o Nonsteroidal Anti-Inflammatory Drugs o Immune-Suppressing Drugs o Hormone Replacement Therapy o Physical Therapy o Blood Transfusion o Plasma Exchange o Others Market, By Product: o Kits and Assays o Reagents o Instruments Market, By End-User: o Hospital o Clinics o Diagnostic Laboratories o Others Market, By Region: o North America - United States - Mexico - Canada o Europe - Germany - France - United Kingdom - Italy - Spain o Asia-Pacific - China - India - Japan - South Korea - Australia - Singapore o Middle East and Africa - South Africa - Saudi Arabia - UAE o South America - Brazil - Argentina - Colombia

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in global autoimmune disease diagnostics market.

Available Customizations:

With the given market data, we offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

Detailed analysis and profiling of additional market players (up to five).

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Global Autoimmune Disease Diagnostics Market By Type, By Sex, By Age, By Factors, By Diagnosis, By Types of Treatment, By Product, By End-User, By...

Recommendation and review posted by Bethany Smith

Faith at her hom during the interview

Faith Were Mukulu was a modern day sports woman trapped in a different generation as she dedicated 50 years to sports service.

Three months shy of her 91st birthday, the confident and energetic nonagenarian looks back at what her life in sports service was as she broke barriers to see to it that netball and athletics rose to the forefront.

Early LifeShe pioneered the growth of the Uganda Netball Association where she became the first female netball referee in Uganda and East Africa with a first class. Her knowledge of the game was head and shoulders above anyone's and for that reason alone, she traversed Uganda and East Africa teaching the sport.

"In our time, sports was not about money but more about love and passion. We were never paid for playing. I used to play netball and athletics which sometimes required me to run from one activity to the other," Were explained.

Born on October 5 1929, to Daudi and Abigail Were, she was raised in Mukono where her parents had moved from Busia before their marriage in 1918. She attended Misindye-Goma Primary School, Mukono Primary School and Nsangi Primary School where she completed her primary leaving certificate.

She later joined Ndejje Teachers Training College (TTC) where she got her grade one teaching certificate in 1948-1951. She upgraded to a grade two certificate between 1960-1963 at Busubuzi TTC, Ndejje TTC and finally Kibuli TTC.

Start of Sports serviceGetting started in sports was not easy because she grew up at a time when boys and girls were assigned sports based on their gender at the height of the British colonial rule in the 1930's and 1940's.

Boy's thanks largely to their genetics were expected to play the more gender appropriate and contact laden football while the girls could only apply their deft touch to netball. This left athletics as the only discipline that was gender neutral which gave many individuals a chance to double up wherever they could.

Perhaps it's because of these circumstances that Mukulu whose time at the Ndejje only managed to fuel her appetite for netball and athletics.

With her teaching certificate in hand she was posted to Kako Primary School as a games teacher in 1952. A year later she joined Namirembe Infant Primary School where she spent the next 31 years of her life teaching and imparting sports knowledge to the kids.

"I was a games mistress at Namirembe Infant School and because I did so well with my school I was chosen as a national team matron (athletics)," explained Were.

Her work with Namirembe was so good that she created one of the best netball and athletics teams in the country.

She broke bounds by becoming an administrative member of the Uganda Netball Association in 1954 which led to her greatest sports management roles of her life. Athletics

At only 25 years old she was asked by the National Council of Sports (NCS) to become national team matron for girls or what is in the modern day known as a team manager.

"At first I didn't want the role because I was still young and I thought it would mess with my faith but the head teacher at Namirembe advised me to take the opportunity," Were said.

For a young lady who gave her life to Christ in 1948, the role was a challenge but it was God's plan.

"As much as I had rejected the role three times, it worked wonders because the players respected me and even started calling me Mukulu which I started using officially as well," she said.

She found fulfilment in the Uganda Athletics team which was very good and was revered within East Africa where they dominated.

In that key role she was able oversee the national teams that travelled for games in Kenya, Tanzania, Nigeria and Zambia. She travelled to New Zealand for the Commonwealth Games and oversaw the national teams for various global netball showpieces.

"I was in charge of ensuring team discipline and we had good players like the great John Aki-Bua who did so well in the Munich 1972.I never experienced a lot of hardship while in charge of the team because all Uganda's players where very engaged in doing well."

After she finally accepted her new role after a fourth appointment by the national council of sports, in 1966 she led the national athletics team to Kenya and Tanzania for various competitions. She then travelled with the national tem to the East and Central African Championships in Lusaka Zambia 1971, All Africa Games Nigeria 1973, and Commonwealth Games New Zealand 1974, World Netball Championships 1979, East and Central African Games 1985.

NetballWhile in Netball, she practically carried the sport on her shoulders as she took her role to grow the sport to another level. She went on to Open the Buganda Netball Association, she started the first women's netball team called Kampala City Council currently known as the Kampala Capital City Authority in 1965.

She also started the Nabbagereka Netball Cup which was a tournament geared towards taking netball to the masses.

"Growing up very few schools used to play netball because it was only a select few who took part in playing the sport like Gayaza, Nsube, Buddo but me and a few colleagues who included rev. Kakooza, Israel Kanankulya decided to start the Nabagereka Netball Cup to take the sports to other schools," she said.

In the same period she took on her role as team manager for the national athletics team. In 1968 she became the first female netball referee in Uganda and the rest of East Africa.

She was one of five referees selected to officiate in the 1979 World Netball Cup in Trinidad and Tobago . It was a rude awakening for her as she had to watch the national team lose badly but in essence they learnt from the experience.

"I officiated in the 1979 World Cup and the person who had earlier coached me nominated me to take part. Uganda had a torrid world cup that year because they were first timers and simply out of depth. The whites were on another level they would jump like monkeys and would pass the ball sometimes in the air which was nothing the team had ever seen," she recounts.

She credits former minister Bidandi Ssali as he helped the women's team to travel.

She led the national netball team to the East and Central African Netball Championships in Lusaka 1985 as head of delegation before seating as an executive member in the National Council of sports from 1988-1989.

She officially retired from active sports in 1990 but has tried her level best to keep tabs on the national teams for netball and athletics.

Reservations"My only disappointment is that Ugandan netball has gone quiet. Yes the team has been to the World Cup but so did we in 1979. I would like to hear more about the sport because during my time I would go on radio and educate the masses about the sport of netball," she said.

Her only regret is that the best athletes like Aki-Bua are no more but would have loved for the rest to see them at their best.

"John Aki-Bua was very good but he wasn't the only one. Our boys were very good here and within East Africa and so were the girls. If only you had seen Mary Musanyi, Christine Kabanda and Beatrice Ayaa at their best you would have been impressed."

She has advised girls to love what they do and also urged government to continue investing in sports like netball.

"I advise young girls to love netball so much because we also loved it. They should put emphasis on our sports as women," she concluded.

More here:
Faith Were: A 91 Year Old Administrator With A Heart For Sports - New Vision

Recommendation and review posted by Bethany Smith

Behaviour is satellite responses to its environment generated by our social brain the system which we consider as mind. Mind endeavour over persuasion on which behaviour develops. Our characters are responses of some hormones produce in the cell of different gland. The shift in concentration of hormones leads to change in character.

This article reviews various effects of hormones on our physiological status and hence behavioural responses. All the body hormones produced by body cell are actually controlled and managed by the genes present in the cell. As the brain (hypothalamus) sense any character or any situation it sends the response to various hormone glands and the glands synthesis the protein as per the command of active gene.

Depending upon the circumstances behavioural response shifts vary wisely. As the behaviour is controlled by the hormones, the genes which are modulating hormones synthesis must be switching off and on as per response from brain. Specific hormone for the specific task of behaviour is produced under the command of brain. We have tried to establish a relationship between behaviour and genes so that a new study should carry out in the motive to control the gene activity by the mode of behaviour psychology. The word Acharangenetics can be used to express the relation of behaviour psychology and genes. The wordAcharangeneticsis a compound word, form by combination of two words Acharan Hindi origin word meaning behaviour and the second word is genetics the study of heredity.

The strength of any construction is understood by its pillars which are multidisciplinary in nature. To hold its existence one has to focus on its sub fundamental phenomenon, that is, behaviour. According to psychology, behaviour comprises of satellite responses to its environment generated by our social brain (Frith, C. D., 2007) the system which we consider as mind. The conscious exercise of faculty and thought are considered very important for development of mind. Mind endeavour over persuasion on which behaviour develops. Psychological practice is very commonly performed by psychologist in order to provide counselling to a person living life with some non-productive state of mind (Strong et al., 1992).

Hence, counselling can help a person to generate positive psychology, and stabilize the social life of a person with any social psychological disturbance (Harris et al., 2007). Our characters are responses of some hormones produce in the cell of different gland. The shift in concentration of hormones leads to change in character. This article reviews various effects of hormones on our physiological status and hence behavioural responses. Body hormones produced by body cell are actually controlled and managed by the genes present in the cell. As the brain (hypothalamus) sense any character or any situation it sends the response to various hormone glands (Knobil, et al., 1980; Schally, et al., 1973) and the glands synthesis the protein as per the command of active gene.

Depending upon the circumstances behavioural response shifts vary wisely. As the behaviour is controlled by the hormones, the genes which are modulating hormones synthesis must be switching off and on as per response from brain. Specific hormone for the specific task of behaviour is producd as per program under the command of brain. We have tried to establish a relationship between behaviour and genes so that a new study should carry out in the motive to control the gene activity by the mode of behaviour psychology.

Counselling psychology is very much practice in the field of academic, in the field of sports for motivating sportsman and for helping the one who is trying to come back after injury (Webster et al., 2008) or in the area of medical for strengthening the depress state of the patients suffering from chronic diseases like cancer (Watson et al.,1988; Sheard, T., & Maguire, P., 1999), diabetes (Snoek et al., 2002) or in any chronic diseases (Karademas et al., 2009) that has harassed the health as well as the mental stability of patients. Moreover, it is widely used in people who are handling life defeat mentality (Silbert et al., 1991). They are found to be very much effective in uplifting the level of psyche.

In psychology, human nature and motivation have been discussed very extensively. Freud believed that behind every human activity there is the instinctual drive that works as a motivating factor that bring upon types of human behaviour. Psychology is a science of behaviour that is observable. It also means an objective science that depends on the experimental and observable data. All human action and behaviour are the outcome of the physiological and neurological reaction in the human body. This fact also reveals that human behaviours are nothing more than the way man responses to stimuli that come from the environment.

Behaviourists accept determinism in their version of psychology. They deem that every human response can be predicted in relation to the type of stimulus that triggers mans responses. Some of our motives to act are biological, while others have personal and social origins. We are motivated to seek food, water, and sex, but our behaviour is also influenced by social approval, acceptance, the need to achieve, and the motivation to take or to avoid risks, to name a few (Morsella, Bargh, & Gollwitzer, 2009).

Furthermore, during motivation our body gene regulation work on activation of genes that is good in handling stress. And there are some genes that are responsible for the production of dopamine a motivation molecule, that provides the drive and focus you need to accomplish your tasks in the most productive way. This hormone is primarily involved with the attention span, focus and motivation. It is a neurohormone that is released by the hypothalamus. Lack of dopamine in the body is associated with symptoms like fatigue, lack of focus, difficulty in concentrating, forgetfulness, insomnia and lack of motivation.

When dopamine isnt regulated properly, it can contribute to a dysfunctional pursuit of good feelings, such as occurs in addictions, or lead to a hyperactive state like Attention Deficit/Hyperactivity Disorder (ADHD). These conditions are generally associated with an increased risk of early death, rather than longevity, but the latest study suggests that risk genes for certain problems in some environments may be beneficial in other situations.

In humans, dopamine neurotransmission is influenced by functional polymorphisms in the dopamine transporter (DAT-1) and catechol-Omethyl transferase (COMT) genes. The COMT and DAT-1 genes was found in the ventral striatum and lateral prefrontal cortex during reward anticipation and in thelateral prefrontal and orbitofrontal cortices as well as in the mid-brain at the time of reward delivery, with carriers of the DAT-1-9 repeat allele and COMT met/met allele exhibiting the highest activation, presumably reflecting functional change consequent to higher synaptic dopamine availability.

The origin of motivation can be felt as either internal as push motivation or external as pull motivation. Push motivation is depicted in terms of biological variables arising in a persons nervous system and mind psychological variables that represent attributes of a persons mind, such as psychological needs. A person has the capability to channelize its motivation and stress hormones concentration by the mode of imagination. And if a person thought is responsible for its hormone concentration, then the person thought or imagination may affect an individual gene regulation. And this gene regulation is a background of push motivation.

Pull motivation is understood in terms of environmental variables that describe external sources of motivation, like incentives or goals. Our internal sources of motivation interact with external sources to direct behaviour (Deckers, 2014). Moreover, it may happen that this external effort implants an idea in a person which allows creating a thought process rising to an imagination.

Furthermore, this imagination leads to affect the body serum metabolite concentration and signalling metabolite modulates the process of gene regulation and gene expression. Hence, it will lead to regulation to the activity of stress handling and risk handling genes (Yashin, et al., 2012). And this leads to the production of hormones such as dopamine, oxytocinetc that are responsible to manage the level of external motivation or push motivation. This system can be observed in the field of extensive sports like boxing and rugby, where coach try to motivate the energy and skills of the player by mentoring with either using sound modulation or by some moral thought related to winning or losing.

Our evolutionary history also explains aspects of motivated behaviour, and our individual personal histories shed light on how our lifelong experiences shape our motives and determine the utility of goals and incentives.

Physiological needs like hunger, thirst, sex or some desire on the basis needs are also the biological beginnings that eventually manifest themselves as a psychological drive in a persons subjective awareness. These biological events become psychological motives. It is important to distinguish the physiological need from the psychological drive it creates because only the later has motivational properties.

The drive theory of motivation tells us that physiological needs originate in our bodies. As our physiological system attempts to maintain health, it registers in our brain a psychological drive to satisfy a physiological craving and motivates us to bring the system from deficiency toward homeostasis (Reeve, 2018). Likewise, the person who motivates themselves for the personal fitness must be channelizing their serum hormones effect. This desire might be helping them to initiate a program of self-caring; a necessity in order to keep up with personal health. As people are not under control for good diet or healthy life style; personal motivation is necessary. The biological need turns into a psychological motive when the drive to satisfy it interferes with our normal functioning by increasing tension until the need is satisfied.

Behavioural feature in relation to social interaction has performed wonders in the field of medical science. Some aspects are visible through the lenses of science but some are the trades of invisible energy. Placebo effect is among that invisible behavioural energy which has stuns the eyes of many thinkers. As per the Stimulus substitution models posit that placebo responses are due to pairings of conditional and unconditional stimuli (Montgomery et al., 1997). This Condition is either created by people or may be a natural place. The placebo effect has a very vital consequence on the synthesis of metabolites in body and in functioning of hormonal glands. Placebo effect gives rise in endorphin release (Levine et al., 1978) and drop down the symptoms of anxiety (Sternbach et al., 1968.), classical conditioning (Wickramasekera et al., 1980), and response expectancy (Kirsch, et al., 1985; Kirsch et al., 1990.).

However, Montgomery and Kirsch (1996) described data that are hard to reconcile with the hypothesis that placebo responses are mediated by such global mechanisms as anxiety reduction or the release of endogenous opioids. It has been found that it can be used as a local anaesthetic.

Genetics states that, what we express as a character, whether its behaviour or phenotype it is just a pre-programmed stimulus of genes on its switching circumstances. And the circumstances could be behavioural or environmental. The change may arise sooner or later, depends on the degree of gene regulation.

On the other hand, the arising of any action or the way someone conduct them self in response to others action is judge during psychological practice. It has been observed that the change in mood, action and development of thought triggers the secretion of different metabolite, by different gland present in different parts of brain and body. The effect of any action could be seen all over the body, such as; at the time of anger the whole body share the heat arise from anger; at the stage of happiness we can feel comfort and energetic and at the stage of meditation we can feel peace. These kicks off of anger can take place by others behavioural activity but its onset initiates the production of adrenaline and noradrenaline cortisol, which anger are causing hormones. Similarly, the state of happiness is the result of production of endorphins, dopamine and serotonin. Likewise, the action of meditation kicks off the production of all good hormones required by the body to be at peace.

The effect of these hormones on whole body can only be seen if these hormones are well distributed in the body cell. Whenever any hormone enters into cell it creates a signalling response which moves from cell cytoplasm to the nucleus. And nucleus is the place where the key genetic material which codes for the behaviour of cell the structural unit of organism.

Psychology and metabolism are mutually related to each other. Any change in psych will trigger the synthesis of different hormones or metabolite or its responsible for the alteration in concentration of metabolite or hormones. And in normal condition of outer environment, social environment and diet intake, the physiological status of a person is found to be normal. Hence, the metabolite concentration is also balanced. As soon as there is any change in the environment (social/environmental) of a person, metabolite and hormonal response changes. Hence there are vital changes in person behaviour or in its health status. There is certain situation where organism has to behave against their natural character. This situation is either created by the social environment or unpredictably. Table 1 listed some of the real life situation and various responses of body metabolism

Moreover, there are situation which are either created or present naturally and are responsible for generating some rare characters in organism. As in a situation for survival some people develop very high spirit to stay alive and start working against their nature. They are found to handle stress condition with an attitude of solving it and bring out anything good as per the things available. This can be the situation of specific activation of stress handling genes by the mode of gene regulation (Yashin, et al., 2012). This regulation tends to modulate behaviour in an organism as presented in Table 2. Hence, such people are found to be having great surviving skills and a behaviour of handling tough situation.

The character whichis in phenotype form or specific social behaviour is actually a command program of the genes present in our DNA. The happening of any behaviour and expression is basically the activity of genes. Hence, learning, expression or behaving could be on and off of genes activity. This on and off of genes is understand by the terminology of gene regulationLikewise, the metabolite or hormones are actually functional protein which produces bytaking the referencefrom the coded information, by various genes in DNA of an organism. Furthermore, the behaviour of person is more likely influenced by the metabolite and hormones. Hencehuman behaviour is more likely to be as concentration of different biochemical or its just based on switching on or switching off of different genes responsible for different character which are control by production of functional protein. Hence, whenever there is activation of any gene there is activation of a specific function which contributes in any biochemical reaction throughout the body. There arenumerous biochemical reactions going on in the bodyeachactually channelize by the metabolic protein produce by the activation of genes of an organism. Apparently, the origin of basic behaviour characteris trigger by genes e.g.in infant we can observe some facial expression and actionInfants are not taught about behaviour, some of them are basically inherited by birthwhich are trigger by genes.

Moreover,if any human psychological disorder generated either by environmental or social stress are responsible for the alteration of functional protein such as hormones and metabolites. Functional protein is only produce by the activation of genes. In a nutshell genes are responsible for behaviour psychology butbehaviour psychology also holds the capacity to influence the activity of genes. Therefore, behaviour psychology at its best possible organised way may have the efficiency to govern and channelizes the activity of genes. Hence, after recognising the complete relation between psychology and genes by the connection of metabolism we can elaborate new area of study either in the field of genetic engineering or in the field of behaviour psychology.Acharangenetics(Acharan + genetics) word can be used to express the relation of behaviour psychology and genes. The wordAcharangeneticsis a compound word, form by combination of two words Acharan a Hindi origin word meaning behaviour and the second word is genetics which is the study of heredity.

Research Questions: The research questions are:

> Can we effect gene regulation by the mode of behaviour psychology?

> Can we use behaviour psychology as a genetic regulation tool?

> As genes activation affect the behaviour and create a person personality characters, can it happen that moulding someones character results in gene regulation?

Answers to the Question

The behaviour of a person is the expression of genes. The change in behaviour by the action of word may generate such hormones which leads to the expression of different genes in the individual which codes for such protein that either alter or generate new character in an individual. Hence, the transformation of human behaviour from a child to a mature person could be response of expression of genes by certain behavioural activities. A talk between two people regarding certain mutual adjustment in behaviour could be another example of gene expression of desired characters by using concept of mutual understanding of requirements. Hence, psychology can be used as a tool for expression of specific genetic traits. If social interaction and genes both affect metabolism, then they might be interacting each other. Metabolic pathway is a connective link in many biological processes therefore; it may happen that there might be a relation between genetics and behavioural psychology. If behaviour psychology can affect genes activity, then we can use it as a tool for expression of specific genetic traits. Any effect to a person during social interaction create certain level of change in its hormones or functional protein concentration lifting the mood or results in stress conditions.

*About the authors: Rajan Keshri, Harpreet Kaur and Dr Gursharan Singh Kainth, Guru Arjan Dev Institute of Development Studies

REFERENCES

Table 1: Hormone Impact on Behaviour and Body at Different Stress Situation.

Table 2: Some Examples of Hormones and Their Effects on Human Body and Behaviour.

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Acharangenetics: Behavior Psychology As Gene Regulation Tool - Analysis - Eurasia Review

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The Dottirs are well renowned throughout the CrossFit world. With two female athletes that have won the Games twice (Annie and Katrin), and another athlete that has won the Worldwide Open three times (Sara Sigmundsdottir), they are a force to be reckoned with. Flick through the photos below for inspiration then read on to explore why they are so good.

Annie Thorisdottir, Katrin Davidsdottir, Sara Sigmundsdottir and Thuridur Helgadottir: four Icelandic ladies dominating the biggest Crossfit stages of all. However, they are not the only dottirs to watch at major events of the discipline, as there is a constant flow of elite sportswomen coming to Crossfit fame from the land of volcanoes, geysersand impressive athletic success stories. To every fan of Strongman, Crossfit, handball, basketball, and, more recently, after the European Championship of 2016, football, the ability of a country with a population of just 323,000 to select and train athletes who go on to feature among the worlds best is a cause for awe and admiration.

The question comes naturally: what lies behind these unlikely accomplishments? In this article, while focusing on Crossfit and Strongman, we set out to explore the different possible factors which contribute to Icelands important place in the world of sport.

It is often believed that the genetic set-up of the Nordic people explains their physical strength and mental toughness, two key ingredients for achievements in sport. However, as few to no studies have been carried out regarding this matter, it is difficult to determine the extent to which genetics offer Icelandic sportsmen and sportswomen a physical or psychological advantage over their competitors. The aforementioned argument is based on the infamous force and brutality of the Icelanders ancestors, the Vikings, who settled on the island in the year 874. Vikings were a tough people, who enjoyed strength training in the form of outdoor sports such as competitive stone lifting. This pastime and its adapted versions seem to have remained popular in Iceland throughout the ages, and could be regarded as part of the Vikings cultural legacy.

With cold weather, long hours of darkness, frequent volcanic eruptions and a rough terrain, life in Iceland is not easy. Before the emergence of modern entertainment, the options of spending ones free time were limited, a fact which may also explain the popularity of indoor sports among the Icelandic population.

However, the environment is an adversary and an ally of the Icelanders at the same time, as it also provides them with clean water and a cuisine based on local fish, vegetables and dairy products. Fully powered by geothermal and hydroelectric energy, Iceland is one of the least polluted countries in the world, which positively influences the quality of water and crops. Given the importance of a sportspersons diet as a factor determining athletic performance, the healthy food products available in Iceland may also be contributing to the achievements of Icelands Crossfit dottirs.

Besides endurance and mental toughness, another psychological trait strongly influenced by geographical and historical factors and also believed to have been inherited from the Vikings is hard work. The efforts related to regularly coping with natural disasters and harsh living conditions shaped the personality of the Icelandic people, who have learned to overcome difficulties and thrive in an unfriendly environment. Icelanders start working at an early age, encouraged by the countrys government, which organizes summer jobs for teenagers aged 13-15. It is usual for students to work part-time during their studies, while many adults have more than one job.

A second trait displayed by Icelandic Crossfitters and other athletes is ambition. If we were to refer to the Viking ancestors again, it is fair to say that they were no cowards lacking self-confidence.

Sport is very popular in Iceland in both its amateur and professional forms. From a young age, pupils are encouraged to actively engage in exercise, among others with the help ofSklahreysti, a competition between schools. The fitness culture in particular is very well-developed, and Crossfit occupies a central position. Icelanders of all ages are active in the discipline at various levels, inspired by the success of the countrys Crossfit superstars.

Boxes face constant demand, with classes at the famous boxCrossfit Reykjavikstarting every 20 or 30 minutes. Furthermore, there is intense competition, but also collaboration, between Icelandic boxes, as Helga Gudmundsdottir, the owner of Crossfit Hafnarfjrur mentions in ourinterviewwith her:We have connections to most of the boxes in Iceland. Iceland is a very small country and we are all starting to know one another. It is like a one big family. We are all happy to lend out gear for competitions or events. So its a community and all boxes are connected somehow.

Another example which illustrates the importance of sport in Iceland is the context in which Junior Nordic champion in Olympic WeightliftingFreyja Mist Olafsdottirdecided to take up Crossfit:on Icelands National Holiday, various sports were being showcased downtown. The Crossfit Reykjavk Regional and Games competitors represented Crossfit and they were doing stuff like pull ups, handstand push-ups and muscle ups, and I thought it looked so cool to be able to do all of those things so I signed up right away.

Besides Crossfit, another popular discipline promoting Icelandic sport nationally and internationally is Strongman. The country gave the world two four-time Strongest Men, Jon Pall Sigmarsson and Magnus Ver Magnusson, and is now home to Europes Strongest Man, Hafthor Julius Bjrnsson, also known in popular culture for his role in theGame of Thronesseries. Considering its ongoing popularity, Strongman seems to have established itself as a traditional Icelandic discipline. Furthermore, Strongmen and Crossfiters sometimes train together and assist one another in making progress, and it is likely that the renowned Strongman discipline plays a part in the achievements of Crossfit athletes from Iceland.

Now that we have looked at some possible answers to the question regarding Icelands achievements in international sport, it is time to turn our attention to a very visible pattern which has emerged in Crossfit, namely the domination of Icelandic ladies. While the sport is probably just as popular among the men of Iceland, also yielding significant results (Bjrgvin Karl Gumundsson came in 3rdat the 2015CrossFit Games), it is in the womens category that the country celebrates its biggest and most numerous successes. Why is it so?

To explain this, we must focus on the principle of gender equality, which has a long history in Iceland. Women are known to have enjoyed many rights and liberties in the times of the Vikings. Furthermore, female warriors known asshieldmaidensare often mentioned in Scandinavian folklore and mythology, leading to the assumption that Viking women accompanied the men on the battlefront. In 1980, Iceland was the first country to democratically elect a woman as its head of state, while in March 2017 it celebrated Womens Day by becoming the first to require gender pay equality. It is therefore no surprise that the island constantly tops the ranking in theGlobal Gender Gap Report.

When it comes to sport in general and Crossfit in particular, this is reflected in the general attitude of Icelanders towards what is generally considered appropriate or desirable for women to do or look like. There is nothing unusual about Icelandic women taking up Crossfit, and it may well be that they do so without fear of being judged or body-shamed. In turn, together with the previously mentioned physical and psychological attributes, a large number of active female Crossfitters leads to a higher chance for the country to produce top sportswomen. Of course, the example set by Annie Thorisdottir and the others plays an important role as well.

Combining sport with social, cultural and historical facts or even genetic backgrounds, the question of explaining a countrys domination in a certain discipline is fascinating and puzzling at the same time. Although it is impossible to determine the accuracy of the answers and despite the fact that the matter usually remains unresolved, the feats achieved by a nations athletes in a certain discipline, such as those of small but mighty Icelands dottirs in Crossfit, are sure to inspire and motivate current and future generations of sports enthusiasts worldwide.

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18 Awesome Action Shots of the Icelandic Dottirs (and what makes them so good at CrossFit?) - BOXROX

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Adrianna and Ashley Tousignant celebrate their pregnancy in a field of sunflowers. Their baby boy was born June 19.

After an exhausting four hours of pushing, Adrianna Tousignant looked down. In her arms was a 9-pound, 1-ounce baby boyit was one of the greatest moments of her entire life, she said.

Even better, she said, was watching her wife, Ashley Tousignant, hold their son, Henry.

Adrianna, 31, and Ashley, 32, fell in love while bartending at Gators Dockside in Gainesville six years ago. Nearly two years later, they were married and immediately began working on having a child. It took them three years to get pregnant.

Same-sex couples have two options for having children: adoption or assisted reproductive technology, which includes methods of conception, like in vitro fertilization, traditionally used to treat infertility. This technology allows for same-sex couples to obtain either a sperm or egg donation and have a child that shares genetics with one parent. Two men would also need a surrogate, a woman who carries and births the child for the couple.

According to Marla Neufeld, a Florida surrogacy attorney, there are no laws in the state preventing same-sex couples from using assisted reproductive techonology to have a child. However, same-sex couples worry about potential future legal issues and social stereotypes when going through the process.

The non-biological parent had to second parent adopt to officially have parental rights prior to 2015, when the supreme court declared same-sex marriage legalin all 50 U.S. states, Neufeld said. Second-parent adoption is a two-month process that involves a petition, finger-printing, a background check and a home-study under Floridas adoption laws.

Now, parents can avoid this process, if married, because a married couple has presumed parentage under Florida law.

However, like many other LGBTQ+ couples, Adrianna and Ashley said they fear the same-sex marriage law will one day be reversed. On June 12, the Trump administration reversed Obama-era health care protections for transgender people and redefined sex discrimination as applying to females and males. The protections do not include discrimination based on sexual identity or sexual orientation.

For extra security, Ashley, who did not carry the baby, is considering adopting their child.

Neufeld said she recommends that the parents do a stepparent adoption after the baby is born in case laws change, even though they're both on the birth certificate. Over the course of a month, the couple would file an adoption petition, attend an adoption hearing and attain a stepparent judgment. A court order is a stronger protection than a birth certificate, which is only a presumption of parentage, Neufeld added.

Ashley and Adrianna said they first began their journey of having a child with intrauterine insemination, a treatment where a sperm is placed inside a woman's uterus to initiate fertilization. To fertilize, the sperm needs to reach the actual egg on its own.

This didnt work.

Adrianna, who volunteered to carry the baby, then tried to medically increase her chances of getting pregnant by having endometriosis surgery. Endometriosis is a complication with the tissue that normally grows on the inside lining of the uterus. In surgery, the doctor removes the tissue, which then increases a womans chance of getting pregnant.

The surgery also didnt lead to a pregnancy, so they decided to switch to IVF, a process where the egg is fertilized with sperm outside of the body and transferred to the uterus.

Finally, three years later, they were pregnant.

Without knowing if you have fertility issues, it's kind of a crapshoot, Adrianna said.

She said they carefully decided who would be the sperm donor because they wanted to make sure the baby also had Ashleys characteristicsher dark brown straight hair and average height.

Ashley said it's a different experience for the partner who is not the one giving birth. When going to doctors appointments, she said, staff would assume she was a family member and not the other parent. She even said a doctor completely ignored her once.

You still feel like you have to kind of fight for your rights, Ashley said. Especially from a female standpoint. Even though you're not the one that's actually doing the pushing and going through everything, you're still an important factor, and should be treated just the same as a dad.

Ashley said they had a great delivery experience together. However, dealing with paperwork after birth was tricky. When applying for their son for a social security number, the representative initially only took down Adriannas number and had to return to the hospital room for Ashleys after the representative realized their mistake.

Being the partner, it was a different experience, Ashley said. Probably not as pleasant I think as others might experience or a heterosexual couple.

Both Ashley and Adrianna said they worry about the current political climate and feel they have to continue fighting for their rights. In January, Tennessee Gov. Bill Lee signed a bill which allows adoption agencies to deny a couple the opportunity to adopt based on religious or moral objections. The couple said they worry something similar will happen in Florida in the future.

Its just like a tornado, that you don't know where it's going to hit, or how destructive it could potentially be, Adrianna said.

However, there are positives too, the couple said. The U.S. Supreme Court outlawed discrimination against the LGBTQ+ community in the workplace on June 15.

Adrianna said she believes times are changing. Hopefully for the better, she added. The couple plans to have more children and just bought a house in Fort White together. She said Henry was definitely worth the wait.

The couple wants Henry to grow up knowing it's OK to be whoever he wants to be. Adrianna said the most important thing a child needs is support and love.

Love makes a family, Adrianna said.

Contact Emma at [emailprotected]ligator.org. Follow her on Twitter @emma_V_bautista.

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What its like for a same-sex couple to have a baby through assisted reproductive technology - The Independent Florida Alligator

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Christine Stanley, Ph.D., Chief Director of Clinical Genomics at Variantyx

The answer to questions about human disease can be found in our genes. The difficulty in the past has been the testing process, a sort of trial and error approach of drilling down into the multitude of variants that can be found within the genes, variants that when analyzed in tandem with detailed clinical histories can actually tell the story and lead to a faster diagnosis.

Human beings carry around 20,000 genes and, of those, approximately 5,000 are somewhat understood, and those genes can be associated with several diseases and each disease can be associated with dozens of clinical symptoms or more. It was believed that five percent or less of the human population carry variants involved in genetic diseases. But a recent study in the Annals of Internal Medicine, now suggests the number of people with variants linked to genetic diseases is closer to 20 percent. Many other factors may determine whether an individual actually develops a disorder, but these numbers suggest the acceptance of a new approach that provides the most useful diagnostic data from a single test thats easier on the patients and families and provides the shortest time to a diagnosis and the best chance at implementing treatments.

Here is an important reason. Parents with children suspected of having a genetic disease routinely face a diagnostic odyssey that typically lasts five to seven years and entails seeing an average of seven different physicians. Its an odyssey that comes with an average cost of diagnosis reaching $21,099, more than seven times the cost of a single whole-genome sequencing test.

Historically, genetic testing has been really disjointed. Tests that were developed 10 to 15 years ago are still being run today by laboratories. These tests target extremely specific areas for an exceedingly small number of changes that cause a certain disease. It is like looking under a lamp post. And an individual, who is suspected of having the disease, will be tested for one particular variant or a small number of variants. It is an approach that is lacking in quick, definitive, and accurate results. Unless the tested area accounted for the majority of the disease-causing variants, it then forces the ordering of more tests to try to find other causes of the disease, either within that same gene or within other genes. This is happening sequentially, so the patient keeps receiving negative results, and then additional tests are ordered and the merry-go-round can continue for years. It cost families financially and emotionally. Delaying the time to diagnosis can also close the effective treatment window in cases where early treatment is important for a good prognosis.

Ordering a single whole-genome sequencing (WGS) test right off the bat replaces almost all of those long, cumbersome, and costly processes. It all but eliminates having to endure multiple genetic tests because a patient needs only one sample and one turnaround time for the greatest chance to arrive at the correct diagnosis. More importantly, if the test results were negative and then a new gene associated with the patients disease is reported the next day, and that patient has a variant in that gene, a clinician can make that connection by reanalyzing the data rather than by bringing the patient back in for a new sample. In that way, genomic testing has really revolutionized the entire genetic testing industry by providing a comprehensive analysis with the shortest time to diagnosis.

Whole-genome sequencing does not require the mechanical step of isolating genes first. It enables the identification of different types of variants that labs do not typically see when one isolates genes. It also enables the use of sophisticated algorithms applied via software to allow for the ranking of variants in a way that pulls variants that are known to cause the disease to the top of the list for examination. Variants can also be ranked by looking at the severity of the effect of the variant on genes that most closely match the patients clinical symptoms. Those results are parsed based on the known inheritance patterns of these genes. Patients can be looked at through both of those lenses at the same timethe severity of the changes that are identified, and the changes that match with the clinical symptoms of the patient.

Whole-genome testing will soon become the first line of defense, rather than a last resort for families or individuals seeking clarity on genetic diseases because of its ability to incorporate sophisticated bioinformatics and data interpretation. It is a faster route for the proper diagnosis and treatment for both early-onset diseases like epilepsy and intellectual disabilities, as well as late-onset disorders like ataxia and ALS. It can be used to diagnose almost any genetic disorder spanning such areas as neurology, endocrinology, nephrology, hearing and vision loss, blood disorders like thalassemia, muscular dystrophy, etc. While insurance reimbursement can be challenging today, the insurance payers will come around, as they have always done in the past, because this test saves time, money, and supports better outcomes for patients.

About Christine Stanley, Ph.D.

Christine Stanley, Ph.D., is the Chief Director of Clinical Genomics for Variantyx, a provider of highly specialized genetic testing to clinicians and their patients. Christine is responsible for overseeing clinical genomic interpretations and regulatory compliance for the clinical laboratory.

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Eliminating the Long, Cumbersome and Costly Diagnosis of Genetic Diseases - HIT Consultant

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Predictive Genetic Testing and Consumer/Wellness Genomics Market: Snapshot

Genetic testing comprises examination of ones DNA. The term DNA refers to the chemical database that is responsible for conveying the instructions for functions that need to be performed by the body. Genetic testing is capable of revealing changes or mutations in the genes of living beings, which might result in any kind of disease or illness in the body.

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Predictive genetic testingrefers to the utilization of genetic testing methods in an asymptomatic individual to make a prediction about risk of contacting particular disease in future. These tests are regarded as representation of emerging class of medical tests, which differ in fundamental ways from the usual diagnostic tests.

The global predictive genetic testing and consumer/wellness genomics marketis likely to gather momentum owing to the benefits offered by predictive genetic testing.

The benefits of predictive genetic testing are

The global predictive genetic testing and consumer/wellness genomics marketis influenced by reducing cost of genetic sequencing and technological advancement in the field of genetics. North America is expected to emerge as a prominent region for the global predictive genetic testing and consumer/wellness genomics market in years to come due to high adoption rates of latest technologies in all fields.

Over centauries human DNA has undergone tremendous alteration due to evolutionary and lifestyle changes. They have led to both, advantages and disadvantages over the years. Some have given the mankind a deserving edge over other creatures while the others have led to disorders and diseases. Predictive genetic testing and consumer/wellness genomics market thrives on the growing demand for understanding the lineage of a certain gene pool to identify disorders that could manifest in the later or early stage of a human life. The surging demand for understanding the family history or studying the nature of certain diseases has given the global market for predictive genetic testing and consumer/wellness genomics market adequate fodder for growth in the past few years.

This new class of medical tests are aimed at reducing the risk of morbidity and mortality amongst consumers. The thorough surveillance and screening of a certain gene pool can allow an individual to avoid conditions that disrupt normal existence through preventive measures. The clinical utility of these tests remains unassessed. Therefore, increasing research and development by pharmaceutical companies to develop new drugs by understanding diseases and disorders is expected to favor market growth.

Unlike conventional diagnostic testing, predictive genetic testing identifies the risk associated with potential conditions. In certain cases it is also capable of stating when the disease may appear and the how severe will it be. Thus, this form of testing is expected to allow consumers to take up wellness measurements well in time to lead a life of normalcy, characterized by good health.

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Global Predictive Genetic Testing and Consumer/Wellness Genomics Market: Overview

Predictive genetic testing are used to identify gene mutations pertaining to the disorders that surface at a considerably later stage in life after birth. These tests are particularly beneficial for people from a family with a history of genetic disorder, although they themselves show no symptoms of the disorder at the time of testing. Genetic testing promises to revolutionize the healthcare sector, providing crucial diagnostic details related to diverse verticals such as heart disease, autism, and cancer. As the healthcare sector touches new peaks, the global predictive genetic testing and consumer/wellness genomics market is projected to expand at a healthy growth rate during the forecast period of 2017 to 2025.

This report on the global market for predictive genetic testing and consumer/wellness genomics analyzes all the important factors that may influence the demand in the near future and forecasts the condition of the market until 2025. It has been created using proven research methodologies such as SWOT analysis and Porters five forces. One of the key aspect of the report is the section on company profiles, wherein several leading players have been estimated for their market share and analyzed for their geographical presence, product portfolio, and recent strategic developments such as mergers, acquisitions, and collaborations.

The global predictive genetic testing and consumer/wellness genomics market, on the basis of test type, can be segmented into predictive testing, consumer genomics, and wellness genetics. The segment of predictive testing can be sub-segmented into genetic susceptibility test, predictive diagnostics, and population screening programs, whereas the segment of wellness genetics can be further divided into nutria genetics, skin and metabolism genetics, and others.

By application, the market can be segmented into breast and ovarian cancer screening, cardiovascular screening, diabetic screening and monitoring, colon cancer screening, Parkinsons or Alzheimers disease, urologic screening or prostate cancer screening, orthopedic and musculoskeletal screening, and other cancer screening. Geographically, the report studies the opportunities available in regions such as Asia Pacific, Europe, North America, and the Middle East and Africa.

Global Predictive Genetic Testing and Consumer/Wellness Genomics Market: Trends and Opportunities

Increasing number of novel partnership models, rapidly decreasing cost of genetic sequencing, and introduction of fragmented point-solutions across the genomics value chain as well as technological advancements in cloud computing and data integration are some of the key factors driving the market. On the other hand, the absence of well-defined regulatory framework, low adoption rate, and ethical concerns regarding the implementation, are expected to hinder the growth rate during the forecast period. Each of these factors have been analyzed in the report and their respective impacts have been anticipated.

Currently, the segment of predictive genetic cardiovascular screening accounts for the maximum demand, and increased investments in the field is expected to maintain it as most lucrative segment. On the other hand, more than 70 companies are currently engaged in nutrigenomics, which is expected to further expand the market.

Global Predictive Genetic Testing and Consumer/Wellness Genomics Market: Regional Outlook

Owing to robust healthcare infrastructure, prevalence of cardiovascular diseases, and high adoptability rate of new technology makes North America the most lucrative region, with most of the demand coming from the country of the U.S. and Canada. Several U.S. companies hold patents, which further extends the outreach of the market in the region of North America.

Companies mentioned in the research report

23andMe, Inc, BGI, Genesis Genetics, Illumina, Inc, Myriad Genetics, Inc, Pathway Genomics, Color Genomics Inc., and ARUP Laboratories are some of the key companies currently operating in global predictive genetic testing and consumer/wellness genomics market. Various forms of strategic partnerships with operating company and smaller vendors with novel ideas helps these leading players maintain their position in the market.

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Predictive Genetic Testing and Consumer/Wellness Genomics Market Analysis of Key Players 2025 - Cole of Duty

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