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The Global Direct-to-consumer Genetic Testing market is anticipated to reach XX USD billion with CAGR of xx% over the forecast period 2020 2026.

Market Growth Insight has presented an updated research report on The Global Direct-to-consumer Genetic Testing market which offers insights on key aspects and an overview of the fundamental verticals of the market. The Direct-to-consumer Genetic Testing report aims to educate buyers on the crucial impactful factors like drivers, challenges and opportunities for the market players, and risks. It comprises a thorough analysis of current Direct-to-consumer Genetic Testing market trends as well as future trends. It also throws light on various quantitative and qualitative assessments of the market. The Direct-to-consumer Genetic Testing research report covers every crucial aspect of the industry that impacts the existing market share, market size, profitability status, and more. A comprehensive evaluation on impacting factors the influence growth opportunities for Direct-to-consumer Genetic Testing market players and remuneration.

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The Major Manufacturers Covered in This Report:

Myriad Genetics, Inc., 23andMe, Inc., Invitae, Ambry Genetics, Laboratory Corporation of America, African Ancestry, MyHeritage, AncestrybyDNA, Counsyl, Inc., Pathway Genomics, DNA Services of America, Positive Bioscience Ltd., Quest Diagnostics, Sonora Quest Laboratories, Gene by Gene, Mapmygenome

COVID-19 Outlook:

Researchers have extensively study on the impact of the pandemic on different segments of the Direct-to-consumer Genetic Testing market. They have precisely mentioned the risks associated with the speedy spread of infection in different regions and offered insights on the crucial areas. This will help the businesses to plan their strategies for better Direct-to-consumer Genetic Testing market position post-pandemic. The report also covers qualitative details about when the industry could return on track and potential measures adopted by the Direct-to-consumer Genetic Testing market vendors to tackle the existing situation.

The report further elucidates on the restraining factors in the Direct-to-consumer Genetic Testing market for business owners, strategists, and stakeholders to carefully execute their strategies and achieve their goals. In addition, the Direct-to-consumer Genetic Testing market is segmented on the basis of product, technology, and end-user. These Direct-to-consumer Genetic Testing report segments are thoroughly studied to offer key information like opportunities for business owners, planners, and marketing personnel. It helps them to manage their activities and execute decisive planning to earn more profits. Direct-to-consumer Genetic Testing Report offers insights on each segment and sub-segment for assisting manufacturers to identify key opportunities and expand their business.

Geographically, the detailed analysis of consumption, revenue, Direct-to-consumer Genetic Testing market share and growth rate, historic and forecast (2015-2026) of the following regions are covered:

North America (United States, Canada, Mexico)Europe (Germany, UK, France, Italy, Spain, Russia, Others)Asia-Pacific (China, Australia,South Korea,Japan, India, Southeast Asia, Others)Middle East and Africa (UAE, Saudi Arabia, Egypt, South Africa, Nigeria, Others)South America (Brazil, Argentina, Columbia, Chile, Others)

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In addition, the report focuses on the key technological improvements in the products and key growth strategies adopted by Direct-to-consumer Genetic Testing market players to expand their business vertically and horizontally. Company information, recent strategies, highly demanding products by manufacturers, and manufacturing units including other essential details are mentioned in the Direct-to-consumer Genetic Testing study. Research and development activities and new product development and other trending factors are highlighted in the Direct-to-consumer Genetic Testing report to offer deeper insights to the buyers. The Direct-to-consumer Genetic Testing report is also beneficial to investors for their investment planning and company information.

Study Objective of the Direct-to-consumer Genetic Testing market includes:

Table and Figures Covered in This Report:

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Direct-to-consumer Genetic Testing Market is Growing at a High CAGR by 2024 According to a New Research Report by Myriad Genetics, Inc., 23andMe,...

Recommendation and review posted by Bethany Smith

The Direct-to-consumer Genetic Testing Market research report provides key statistics of the market status in terms of Direct-to-consumer Genetic Testing market size estimates and forecasts, growth rate. This report also covers key players of the market identified through their market share, product offerings. Further, the Direct-to-consumer Genetic Testing market research report strategical insights based on assessment of recent developments, strategy analysis of the players. It also covers drivers, opportunity and challenges prevailing in the industry. The report covers segmental analyses for across the key region North America, Europe, Asia Pacific, Middle East & Africa and South America.

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The Global Direct-to-consumer Genetic Testing market 2020 research provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Global Direct-to-consumer Genetic Testing market report is provided for the international markets as well as 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 analysed. This report additionally states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.

Final Report will add the analysis of the impact of COVID-19 on this industry.

In Chapter 2.4 of the report, we share our perspectives for the impact of COVID-19 from the long and short term.In chapter 3.4, we provide the influence of the crisis on the industry chain, especially for marketing channels.In chapters 8-13, we update the timely industry economic revitalization plan of the country-wise government.

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The objective of this report:

Global Direct-to-consumer Genetic Testing market competition by TOP MANUFACTURERS, with production, price, revenue (value) and each manufacturer including:

Global Direct-to-consumer Genetic Testing Market providing information such as company profiles, product picture and specification, capacity, production, price, cost, revenue and contact information. Upstream raw materials and instrumentation and downstream demand analysis is additionally dispensed. The Global Direct-to-consumer Genetic Testing market development trends and marketing channels are analyzed. Finally, the feasibility of latest investment projects is assessed and overall analysis conclusions offered.

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On the basis of product, this report displays the production, revenue, price, market share and growth rate of each type, primarily split into:

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including:

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2025) of the following regions are covered in Chapter 8-13:

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Some of the key questions answered in this report:

Years considered for this report:

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With tables and figures helping analyse worldwide Global Direct-to-consumer Genetic Testing market trends, this research provides key statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.

Key Points from TOC:

1 Market Overview1.1 Product Definition and Market Characteristics1.2 Global Direct-to-consumer Genetic Testing Market Size1.3 Market Segmentation1.4 Global Macroeconomic Analysis1.5 SWOT Analysis

2. Market Dynamics2.1 Market Drivers2.2 Market Constraints and Challenges2.3 Emerging Market Trends2.4 Impact of COVID-192.4.1 Short-term Impact2.4.2 Long-term Impact

3 Associated Industry Assessment3.1 Supply Chain Analysis3.2 Industry Active Participants3.2.1 Suppliers of Raw Materials3.2.2 Key Distributors/Retailers3.3 Alternative Analysis3.4 The Impact of Covid-19 From the Perspective of Industry Chain

4 Market Competitive Landscape4.1 Industry Leading Players4.2 Industry News4.2.1 Key Product Launch News4.2.2 M&A and Expansion Plans

5 Analysis of Leading Companies5.1 Company 15.1.1 Company 1 Company Profile5.1.2 Company 1 Business Overview5.1.3 Company 1 Direct-to-consumer Genetic Testing Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.1.4 Company 1 Direct-to-consumer Genetic Testing Products Introduction

5.2 Company 25.2.1 Company 2 Company Profile5.2.2 Company 2 Business Overview5.2.3 Company 2 Direct-to-consumer Genetic Testing Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.2.4 Company 2 Direct-to-consumer Genetic Testing Products Introduction

5.3 Company 35.3.1 Company 3 Company Profile5.3.2 Company 3 Business Overview5.3.3 Company 3 Direct-to-consumer Genetic Testing Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.3.4 Company 3 Direct-to-consumer Genetic Testing Products Introduction

5.4 Company 45.4.1 Company 4 Company Profile5.4.2 Company 4 Business Overview5.4.3 Company 4 Direct-to-consumer Genetic Testing Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.4.4 Company 4 Direct-to-consumer Genetic Testing Products Introduction

6 Market Analysis and Forecast, By Product Types6.1 Global Direct-to-consumer Genetic Testing Sales, Revenue and Market Share by Types (2015-2020)6.2 Global Direct-to-consumer Genetic Testing Market Forecast by Types (2020-2025)6.3 Global Direct-to-consumer Genetic Testing Sales, Price and Growth Rate by Types (2015-2020)6.4 Global Direct-to-consumer Genetic Testing Market Revenue and Sales Forecast, by Types (2020-2025)

7 Market Analysis and Forecast, By Applications7.1 Global Direct-to-consumer Genetic Testing Sales, Revenue and Market Share by Applications (2015-2020)7.2 Global Direct-to-consumer Genetic Testing Market Forecast by Applications (2020-2025)7.3 Global Revenue, Sales and Growth Rate by Applications (2015-2020)7.4 Global Direct-to-consumer Genetic Testing Market Revenue and Sales Forecast, by Applications (2020-2025)

8 Market Analysis and Forecast, By Regions8.1 Global Direct-to-consumer Genetic Testing Sales by Regions (2015-2020)8.2 Global Direct-to-consumer Genetic Testing Market Revenue by Regions (2015-2020)8.3 Global Direct-to-consumer Genetic Testing Market Forecast by Regions (2020-2025)Continued.

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Global Direct-to-consumer Genetic Testing Market Size 2020 Industry Overview, Shares, Growing Demand, Explosive Factors of Revenue, Types,...

Recommendation and review posted by Bethany Smith

In this report, the global Predictive Genetic Testing market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2025, growing at a CAGR of XX% during the period 2019 to 2025.

Persistence Market Research recently published a market study that sheds light on the growth prospects of the global Predictive Genetic Testing market during the forecast period (20XX-20XX). In addition, the report also includes a detailed analysis of the impact of the novel COVID-19 pandemic on the future prospects of the Predictive Genetic Testing market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Predictive Genetic Testing market to assist our clients arrive at beneficial business decisions.

The Predictive Genetic Testing market report firstly introduced the basics: definitions, classifications, applications and market overview; product specifications; manufacturing processes; cost structures, raw materials and so on. Then it analyzed the worlds main region market conditions, including the product price, profit, capacity, production, supply, demand and market growth rate and forecast etc. In the end, the Predictive Genetic Testing market report introduced new project SWOT analysis, investment feasibility analysis, and investment return analysis.

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Resourceful insights enclosed in the report:

The major players profiled in this Predictive Genetic Testing market report include:

key players in the predictive genetic testing market. The significant competitive strength of the existing players in the evolving landscape of the global predictive genetic testing market is anticipated to offer new prospect in widening the application of the predictive genetic testing, substantially driving predictive genetic testing market growth. The key manufacturers of the predictive genetic testing are greatly concentrated on the technical edification of the end users to improve consumer outcomes. Furthermore, the adoptions of advanced predictive genetic testing services is expected to create lucrative growth opportunities for the service and third-party market competitors. Growing inclination toward trend in predict is prevention is estimated to offer growth opportunity for Predictive genetic testing market. Selection of treatment regimen with Predictive genetic testing is projected to aid capturing higher share in Predictive genetic testing market.

Geographically, global Predictive genetic testing market is segmented into seven key regions viz. North America, Latin America, Europe, South Asia, East Asia Oceania and Middle East & Africa. North America is prominent region in Predictive genetic testing Market. Advancement in genetic care facilities, higher adoption to lifestyle changes, increase awareness about genetic disease, increase in preventative care and favorable government policies have improved the regulatory scenario for predictive genetic testing devices in north America. Additionally in Asia pacific region considerably higher market growth rate is expected due to constantly rising population and higher incidence of genetic abnormality. Relatively affecting the Predictive genetic testing market.

Some of the major key players competing in the global Predictive genetic testing Market are Myriad Genetics, Inc., Abbott Laboratories, Illumina, Inc., Genesis GeneticsThermo Fisher Scientific, Inc., Bio-Rad Laboratories Inc., , Agilent Technologies, F. Hoffmann-La Roche Ltd., Counsyl, Inc., ARUP Laboratories. BGI among others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

For any queries get in touch with Industry Expert @ https://www.persistencemarketresearch.co/ask-an-expert/31204

The market report addresses the following queries related to the Predictive Genetic Testing market:

The study objectives of Predictive Genetic Testing Market Report are:

To analyze and research the Predictive Genetic Testing market status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast.

To present the Predictive Genetic Testing manufacturers, presenting the sales, revenue, market share, and recent development for key players.

To split the breakdown data by regions, type, companies and applications

To analyze the global and key regions Predictive Genetic Testing market potential and advantage, opportunity and challenge, restraints and risks.

To identify significant trends, drivers, influence factors in global and regions

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the Predictive Genetic Testing market.

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Global Region Likely to Dominate the Predictive Genetic Testing Market Over the Forecast Period 2019 2029 - The Daily Chronicle

Recommendation and review posted by Bethany Smith

A new research report published by Fior Markets with the titleCannabis Testing Market by Product & Software (Analytical Instruments, Consumables, Software), Testing Procedures (Residual Solvent Screening, Terpene Profiling, Potency Testing, Genetic Testing, Pesticide Screening, Heavy Metal Testing, Microbial Analysis), End-User (Laboratories, Cannabis Cultivators, Research Institutes, Drug Manufacturers & Dispensaries), Region, Global Industry Analysis, Market Size, Share, Growth, Trends, and Forecast 2020 to 2027.

Theglobal cannabis testing marketis expected to grow from USD 1.71 billion in 2019 to USD 4.87 billion by 2027, at a CAGR of 14% during the forecast period 2020-2027. North America dominated the market in the year 2019. This growth was due to the growing legalization pertaining to the use of cannabis across various U.S. states, increasing cultivators of marijuana, and the rising number of testing laboratories. The growing demand for cannabis for personal use will further propel the market growth. The Chile cannabis testing market is anticipated to grow due to the growing awareness of the medical use of cannabis and the increase in cannabis use for medical purposes. The Germany market is expected to witness significant growth due to increased approval of production licenses and new medical cannabis legislation.

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

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Some of the notable players in the market are CannaSafe Analytics, Steep Hill, Anandia Labs, Eirlab, Phytovista Laboratories, CW Analytical Laboratories, Pure Analytics, Anresco, EVIO, SC Labs, and Digipath. In January 2019, Hemp Inc. and Digipath Inc. has an agreement to provide on-site potency testing laboratories for three hemp production sites in Arizona and Oregon that are owned by Hemp Inc. This collaboration enabled Digipath to expand its market share and strengthen its position in the international as well as domestic cannabis testing industry.

The product & software segment includes analytical instruments, consumables, and software. The analytical instruments segment is further segmented into chromatography instruments, spectroscopy instruments, and other analytical instruments. The chromatography instruments are further classified into liquid chromatography, gas chromatography, and other chromatography instruments. The spectroscopy instruments segment is further classified into mass spectrometry, atomic spectroscopy, and atomic spectroscopy. The chromatography instruments are further classified into liquid chromatography, gas chromatography, and other chromatography instruments. The spectroscopy instrument segment is anticipated to witness significant growth due to the increasing legalization of cannabis testing and its derivative for adults recreational and medical use. The testing procedure segment includes residual solvent screening, terpene profiling, potency testing, genetic testing, pesticide screening, heavy metal testing, and microbial analysis. The potency testing segment holds the largest market share, owing to the increasing applications of cannabinoids for medical purposes. It is also essential for the precise labeling of medical purposes. On the basis of end-user, the market is segmented into laboratories, cannabis cultivators, research institutes, and drug manufacturers & dispensaries. Laboratories segment dominated the market, due to the increasing legalization of cannabis for medical as well as recreational use, and rising demand for cannabis testing software in labs.

The factors influencing the market are growing number of medical applications of cannabis, rising investment by various research institutes, increasing focus to meet the needs of hemp and cannabis cultivator, and legalization of medical cannabis associated with a rising number of cannabis analysis laboratories. The factors restraining the market are high cost of laboratory equipment and lack of uniformity in quality standards.

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About the report:The globalcannabis testing market is analyzed on the basis of value (USD Billion), volume (K Units), export (K Units), and import (K Units). All the segments have been analyzed on global, regional and country basis. The study includes an analysis of more than 30 countries for each segment. The report offers in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insight of the market. The study includes porters five forces model, attractiveness analysis, raw material analysis, and competitor position grid analysis.

Customization of the Report:The report can be customized as per client requirements. For further queries, you can contact us onsales@fiormarkets.comor +1-201-465-4211. Our executives will be pleased to understand your requirements and offer you the best-suited reports.

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Global Cannabis Testing Market is projected to grow at a CAGR of 14% during the forecast period 2020 - PharmiWeb.com

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Newark, NJ,, Sept. 29, 2020 (GLOBE NEWSWIRE) -- As per the report published by Fior Markets, theglobal esoteric testing market is expected to grow from USD 22.82 billion in 2019 and to reach USD 56.51 billion by 2027, growing at a CAGR of 12% during the forecast period 2020-2027.

The global esoteric testing market is witnessing significant growth from recent years. This growth is attributed to the rising prevalence of chronic and infectious diseases like diabetes, cancer, and various others. Technological advancements such as standardization of advanced instrumentation, antidote automation technology, and analytical systems will propel the market growth. Furthermore, growing awareness regarding early disease diagnosis and its treatment, increasing incidence of complex and unique diseases, and rapidly improving healthcare sector will influence the market growth.

An analysis of a unique molecule or substances that are not performed in the routine clinical laboratory is known as esoteric testing. Esoteric testing requires sophisticated materials and instruments and specialized personnel to perform and analyze results. The doctors require esoteric testing for accruing large amounts of data outside routine tests in labs and overall analysis, prediction and monitoring of the healing regimen. These tests are typically related to medical fields like genetics, endocrinology, microbiology, oncology, molecular diagnostics, toxicology, and serology.

The global esoteric testing market is expected to witness significant growth, owing to the growing awareness of personalized medicines, rising geriatric population, increasing funding and research grants for the development of innovative esoteric tests, and rising demand for early disease detection using specialized diagnostic tests. Unfavourable reimbursement scenario, lack of sufficient expertise, and an insufficient number of esoteric testing modules will restrain the market growth. An increase in private and public funding to support research activities will provide market growth opportunities. However, changing regulatory framework will challenge the market.

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The key players operating in global esoteric testing market are Mayo Medical Laboratories, Laboratory Corporation of America, Fulgent Genetics, Quest Diagnostics, Genomic Health, OPKO Health, Nordic Laboratories, Arup Laboratories, American Esoteric Laboratories (AEL), ACM Global Laboratories, Myriad Genetics, BioMONTR, Invitae, and Miraca Holdings. To gain a significant market share in the global esoteric testing market, the key players are now focusing on adopting strategies such as product innovations, mergers & acquisitions, recent developments, joint venture, collaborations, and partnership. Genomic Health and BioMONTR are some of the leading players in esoteric testing.

Infectious disease testing segment dominated the market and held the largest share of 23.67% in the year 2019On the basis of type, the global esoteric testing market is segmented into endocrinology, infectious disease, immunology, toxicology, neurology, and genetic testing. Infectious disease testing segment dominated the market and held the largest share of 23.67% in the year 2019. This growth is attributed to the high prevalence of infectious diseases and increasing demand for advanced molecular tests, and the availability of immunology laboratory services.

CLIA technology segment dominated the market and held the largest market share of 36.9% in the year 2019On the basis of technology, the global esoteric testing market is segmented into mass spectrometry, ELISA, CLIA, and PCR. CLIA technology segment dominated the market and held the largest market share of 36.9% in the year 2019. This growth is attributed to the advantages of CLIA over other testing methods, low detection limits, superior sensitivity and accuracy delivered, and high adoption of CLIA in esoteric testing. ELISA esoteric technology is anticipated to witness significant growth due to the high throughput screening performed in laboratories, new development in biomarkers, and drug discovery programs.

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Independent lab segment dominated the market and held the largest share of 54.64% in the year 2019On the basis of lab type, the global esoteric testing market is segmented into hospital laboratories and independent labs. Independent lab segment dominated the market and held the largest share of 54.64% in the year 2019. This growth is attributed to ongoing automation and digitalization of diagnostic laboratories, and significant reimbursement coverage for clinical tests performed at independent laboratories.

Regional Segment of Esoteric Testing Market

On the basis of geography, the global esoteric testing market is classified into North America, Europe, Asia-Pacific, Middle East & Africa, and South America. North America held the major share of 29.1% in the year 2019. This growth was attributed to an increasing number of research activities in healthcare, increasing patient population suffering from chronic disease, growing investment in healthcare, and quick adoption of sophisticated instruments. Canada is anticipated to witness significant growth, owing to the increasing demand for cost-effective methods of diagnosis. The South America region market is expected to grow, owing to the increasing demand for treatment options for chronic diseases and technologically advanced devices for diagnosis. The Asia-Pacific region is projected to grow due to an increasing focus on early diagnosis and treatment for rare diseases and the increasing burden of chronic diseases. The Middle East and Africa market is witnessing a steady rise due to an increase in the number of healthcare facilities and awareness about esoteric testing.

Request for Customization:https://www.fiormarkets.com/enquiry/request-customization/418896About the report:The global esoteric testing market is analysed on the basis of value (USD billion). All the segments have been analysed on global, regional and country basis. The study includes the analysis of more than 30 countries for each segment. The report offers in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insights of the market. The study includes porters five forces model, attractiveness analysis, raw material analysis, and competitors position grid analysis.

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Global Esoteric Testing Market Is Expected to Reach USD 56.51 billion by 2027 : Fior Markets - GlobeNewswire

Recommendation and review posted by Bethany Smith

Direct-to-consumer Genetic Testing Marketsize is expected to gain market growth in the forecast period of 2020 to 2025, with a CAGR of 15.0% in the forecast period of 2020 to 2025 and will expected to reach USD 2277.9 million by 2025, from USD 1301.3 million in 2019.

Direct-to-consumer Genetic Testing market research Report is an inestimable supply of perceptive information for business strategists. This Direct-to-consumer Genetic Testing Market study provides comprehensive data which enlarge the understanding, scope and application of this report.

A specific study of competitive landscape of the global Direct-to-consumer Genetic Testing Market has granted, providing insights into the corporate profiles, financial standing, recent developments, mergers and acquisitions, and therefore the SWOT analysis. This analysis report will provides a transparent program to readers concern regarding the overall market situation to further choose on this market projects.

The Direct-to-consumer Genetic Testing Market report profiles the successive companies, which includes: 23andMe, DNA Diagnostics Center, Myriad Genetics, MyHeritage, Gene By Gene, LabCorp, IntelliGenetics

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This report studies the global Direct-to-consumer Genetic Testing Market status and forecast, categorizes the global Direct-to-consumer Genetic Testing Market size (value & volume), revenue (Million USD), product price by manufacturers, type, application, and region. Direct-to-consumer Genetic Testing Market Report by Material, Application and Geography with Global Forecast to 2025 is an connoisseur and far-reaching research provide details associated with worlds major provincial economic situations, Concentrating on the principle districts (North America, South America Europe, and Asia-Pacific) and the crucial nations (United States, Germany, United Kingdom, Japan, South Korea, and China).

Reports Intellect analysts are currently working analyzing and integrating their insights on the effect of COVID-19 across diverse industry verticals. These insights are quite promising for various businesses and industries to cope up with this unprecedented downturn and take effective strategic decisions to thrive and proliferate in the ever competitive business ecosystem.

By Types:Diagnostic Screening, Prenatal, Newborn Screening, and Pre-Implantation Diagnosis

By Applications:Online, Offline

Market Segment by Regions, regional analysis coversNorth AmericaEuropeAsia-PacificSouth AmericaMiddle East and Africa

Table of Contents

Global Direct-to-consumer Genetic Testing Market Size, Status and Forecast 20251 Market Overview2 Manufacturers Profiles3 Global Direct-to-consumer Genetic Testing Sales, Revenue, Market Share andCompetitionby Manufacturer4 Global Direct-to-consumer Genetic Testing Market Analysis by Various Regions5 North America Direct-to-consumer Genetic Testing by Countries6 Europe Direct-to-consumer Genetic Testing by Countries7 Asia-Pacific Direct-to-consumer Genetic Testing by Countries8 South America Direct-to-consumer Genetic Testing by Countries9 Middle East and Africas Direct-to-consumer Genetic Testing by Countries10 Global Direct-to-consumer Genetic Testing Market Segment by Types11 Global Direct-to-consumer Genetic Testing Market Segment by Applications12 Direct-to-consumer Genetic Testing Market Forecast13 Sales Channel, Distributors, Traders and Dealers14 Research Findings and Conclusion15 Appendix

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Overview of the chapters analysing the global Direct-to-consumer Genetic Testing Market in detail:

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Direct-to-consumer Genetic Testing Market will Generate Record Revenue by 2025 with top key players like 23andMe, DNA Diagnostics Center, Myriad...

Recommendation and review posted by Bethany Smith

STEAMBOAT SPRINGS You can hear the love in Mariah Gillaspies voice as she talks about her daughters Emma and Abby, who suffer from a rare genetic disease that causes seizures and development issues.

Emma, shes our oldest, and shell be 4 in October, Mariah said. Shes our calm, sweet little child. She has these little coos that sound like a dove. She really enjoys music, and she loves being around other kiddos her age.

Abby is our younger daughter, and shell be 2 in October, and she is our feisty little thing, Mariah continued. So, she lets you know when shes happy; she lets you know when shes not happy.

There is no question the two girls, the only two people in the world believed to have this disease, are surrounded by the love they get from Mariah and their dad Mark.

Mark grew up in Steamboat Springs and graduated from high school here in 2001. The couple now live in Centennial, but Marks parents, Jeanne and Joe Gillaspie, still live in Steamboat as does Marks older brother.

Four years ago, Mark and Mariah were overwhelmed with joy as they welcomed their first child Emma to the world, but when she was three months old, the couple started to notice she was having some strange movements, and when she started having episodes where she would hold her breath until she would turn pale, the couple took her to the doctor.

The doctor initially thought it was reflux, but when Emma stopped breathing in the doctors office, she was rushed to Childrens Hospital of Colorado for more evaluation and tests.

Throughout all this, I was convinced everything was going to be OK, Mariah said. It never crossed my mind that something was seriously wrong, and I had never considered that these were seizures.

Eventually, Emma was diagnosed with infantile spasms, which Mariah said didnt look serious on the outside but were damaging Emmas brain and impacting her development from the inside. Emma started treatment immediately, and the family was encouraged with the results. But then there was a relapse and a new medication, and then another relapse and another new medication.

Mariah said each new medicine came with a longer list of side effects, and Emmas immune system suffered. She had a bout with pneumonia that left her in the hospital for two months.

Through it all, the Gillaspies continued to search for answers.

We did a whole slew of genetic testing, and it came back inconclusive, Mariah said. They found absolutely nothing that could be the cause of her disease, and they told us this is probably some completely random condition that was caused by something that happened in utero.

They also told the Gillaspies that Emmas condition was rare, and there was less than a 3% chance of it happening again. So after extensive genetic testing, they decided to have a second child.

When Abby arrived two years later, they were thrilled, but at about six weeks, they noticed their youngest daughter was displaying the same movements that Emma had shown prior to her diagnosis. So it was back to the doctors, and it was confirmed through genetic testing that Abby and Emma shared the same mutated gene THAP12.

After discovering their daughters were suffering from the same condition, the family embarked on a grassroots effort to drive research about the rare genetic disease, which led to the creation of a foundation, Lightning and Love, a name that was chosen because the family believes lightning struck their family twice in the form of two daughters with the same rare disease.

The doctors would say, Im sorry, theres nothing we can do. We have to wait for science to catch up,' Mariah said. Every doctor that weve encountered has really been amazing and done their very best for us. Its just unfortunate science hasnt caught up to the girls, yet. Thats kind of, whereas parents, were passionate enough to move science along a little faster.

The nonprofit organization is supported by a GoFundMePage, and tax-deductible donations can be made through the Lightning and Love website.

The latest research funded by the foundation involved genetically engineering a zebrafish model to see if it showed symptoms of disease, specifically seizures. The zebrafish did have seizures, which Mariah said was a major breakthrough toward the ultimate goal of finding a gene replacement cure for her daughters.

But the journey for Mark and Mariah has proven to be more than just research and discovery.

What were realizing is the more we talk about it, and the more we do to get our story out there, the more were realizing that theres a lot of other parents that are going through tough times with their kids, too, Mark said. In an odd twist, or an ironic twist, this tough hand that weve been dealt has actually been a very positive light to a lot of other people out there. For me, that is just as important as the research.

The familys story was recently featured on the podcast, Go Shout Love.

The couples positive message is guiding them along the road they hope will lead to a better life for their family. But in the meantime, Mark and Mariah will continue to put smiles ontheir daughters faces the same way most other parents do by offering their love, support and opportunities to find happiness.

For Emma, that means being tossed into the air and caught by her daddy, and for Abby, it is time in her sensory room and being around her dad and her family.

Emma loves very big movements. Shes not mobile, and she cant walk, so when we kind of throw her around in the air or fly her around the room, she absolutely loves it, Mariah said. Abby loves her daddy. She gives big old smiles when he walks into the room.

To reach John F. Russell, call 970-871-4209, email jrussell@SteamboatPilot.com or follow him on Twitter @Framp1966.

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Family seeks answers, finds hope after daughters diagnosed with rare genetic condition - Steamboat Pilot and Today

Recommendation and review posted by Bethany Smith

Newark, NJ, Sept. 30, 2020 (GLOBE NEWSWIRE) -- As per the report published by Fior Markets, theglobal hemoglobinopathies market is expected to grow from USD 6.35 billion in 2019 to USD 13.72 billion by 2027, at a CAGR of 10.1% during the forecast period 2020-2027.

Some of the key factors that are driving the global hemoglobinopathies market are rising cases of hemoglobinopathies, increasing government initiatives for spreading awareness regarding hemoglobin variant diseases, growing R&D activities for developing novel therapeutics, rising cases of hemoglobin disorders such as thalassemia, Sickle Cell Disease (SCD), Hb C, & Hb E, unmet treatment needs, absence of a permanent cure, improvement in healthcare infrastructure, and rising cases of blood cancer.

Hemoglobinopathy is a genetic disorder that can result in defective globin chains. They are single-gene inherited disorders of which SCD is the most common. There is a high occurrence of Hemoglobinopathies in the Mediterranean, Southeast Asia, and Africa. If left untreated, hemoglobinopathy can lead to organ dysfunction, anemia, and even death in critical cases. Thalassemias, sickle cell anemia, hemoglobin S-C and hemoglobin C are some of the common hemoglobinopathies diseases. Typically, they are found by tests such as red blood cell count, hemoglobin isoelectric focusing, high performance liquid chromatography, etc.

With the outbreak of a global pandemic, many have faced salary cuts and job losses. Covid-19 has become a threat to the entire world's economy and has negatively impacted all kinds of markets, including the hemoglobinopathies market. With less disposable income and broken supply chains for equipment & tools, the market's growth is expected to slow down. Other factors that restrict market growth are diagnostic alternatives to hemoglobinopathies and an insufficient number of proper diagnostics test kits.

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Key players operating in the global hemoglobinopathies market include Alnylam Pharmaceuticals, Gamida Cell, Sanofi, Global Blood Therapeutics, Sangamo Therapeutics Inc., Bluebird Bio Inc., Prolong Pharmaceuticals, Celgene Corporation, and Emmaus Life Sciences Inc., among others. To gain a significant market share in the global hemoglobinopathies market, the key players are now focusing on adopting strategies such as product innovations, mergers & acquisitions, recent developments, joint ventures, collaborations, and partnerships. Global Blood Therapeutics and Bluebird Bio Inc. are some of the biggest players in the global hemoglobinopathies market.

Sickle cell disease dominated the market and held the largest market share of 38.4% in the year 2019

On the basis of type, the market has been segmented into sickle cell disease, thalassemia, and others. Sickle cell disease dominated the market and held the largest market share of 38.4% in the year 2019. The large share of this segment was attributed to the increasing patient awareness about disorders and improvements in diagnosis & treatment. This segment is also expected to expand at a significant CAGR during the forecast period.

Red blood cell (RBC) count test segment dominated the market and valued at USD 1.2 billion in the year 2019

Based on diagnosis, the global market has been divided into genetic testing, red blood cell (RBC) count test, hemoglobin isoelectric (Hb IEF) focusing, hemoglobin by high performance liquid chromatography (HPLC) test, hemoglobin solubility test, and hemoglobin electrophoresis (Hb ELP) test). Red blood cell (RBC) count test segment dominated the market and valued at USD 1.2 billion in the year 2019. The red blood cell (RBC) count test is the most commonly used first-line screening method.

Blood transfusion dominated the market and held the largest market share of 29.3% in the year 2019

Based on therapy, the hemoglobinopathies market has been segmented into blood transfusion, bone marrow transplant, iron chelation therapy, and others. Blood transfusion dominated the market and held the largest market share of 29.3% in the year 2019. The large share of this segment is attributed to factors like its high acceptance, high success rate, and rising government initiatives for increasing blood donations.

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Regional Segment Analysis of the Hemoglobinopathies Market

On the basis of geography, the global hemoglobinopathies market has been classified into North America, Europe, South America, Asia Pacific, and Middle East and Africa. The North America region accounted for the major market share of 45.25% in the year 2019 and is anticipated to grow throughout the projected period. The large share of this segment is attributed to key factors such as increasing R&D investments by major players, good reimbursement scenario, presence of advanced healthcare infrastructure, increasing prevalence of blood disorders, supportive government programs, and rising awareness among patients & healthcare professionals regarding hemoglobinopathies-related genetic testing. On the other hand, the Asia-Pacific region is expected to grow at the highest CAGR during the forecast period 2020-2027. This growth is due to factors like the introduction of low-cost, indigenously-manufactured diagnostic kits for sickle cell disease & thalassemia, rising patient awareness levels, unmet clinical needs, and developing healthcare infrastructure.

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The global hemoglobinopathies market is analyzed on the basis of value (USD Billion). All the segments have been analyzed on a global, regional, and country basis. The study includes the analysis of more than 30 countries for each segment. The report offers an in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insight of the market. The study includes porter's five forces model, attractiveness analysis, raw material analysis, and competitor position grid analysis.

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Global Hemoglobinopathies Market Is Expected to Reach USD 13.72 Billion by 2027 : Fior Markets - GlobeNewswire

Recommendation and review posted by Bethany Smith

Fort Collins, Colorado The Preimplantation Genetic Testing Market is growing at a rapid pace and contributes significantly to the global economy in terms of turnover, growth rate, sales, market share and size. The Preimplantation Genetic Testing Market Report is a comprehensive research paper that provides readers with valuable information to understand the basics of the Preimplantation Genetic Testing Report. The report describes business strategies, market needs, dominant market players and a futuristic view of the market.

The report has been updated to reflect the most recent economic scenario and market size regarding the ongoing COVID-19 pandemic. The report looks at the growth outlook as well as current and futuristic earnings expectations in a post-COVID scenario. The report also covers changing market trends and dynamics as a result of the pandemic and provides an accurate analysis of the impact of the crisis on the market as a whole.

Global Preimplantation Genetic Testing Market was valued at 401.49 million in 2019 and is projected to reach USD796.89 million by 2027, growing at a CAGR of 9.65% from 2020 to 2027.

Industry Preimplantation Genetic Testing Study provides an in-depth analysis of key market drivers, opportunities, challenges and their impact on market performance. The report also highlights technological advancements and product developments that drive market needs.

The report contains a detailed analysis of the major players in the market, as well as their business overview, expansion plans and strategies. Key players explored in the report include:

The report provides comprehensive analysis in an organized manner in the form of tables, graphs, charts, pictures and diagrams. Organized data paves the way for research and exploration of current and future market outlooks.

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The report provides comprehensive data on the Preimplantation Genetic Testing market and its trends to help the reader formulate solutions to accelerate business growth. The report provides a comprehensive overview of the economic scenario of the market, as well as its benefits and limitations.

The Preimplantation Genetic Testing Market Report includes production chain analysis and value chain analysis to provide a comprehensive picture of the Preimplantation Genetic Testing market. The research consists of market analysis and detailed analysis of application segments, product types, market size, growth rates, and current and emerging industry trends.

1.Preimplantation Genetic Testing Market, By Technology:

Next-Generation Sequencing Polymerase Chain Reaction Fluorescence in Situ Hybridization Comparative Genomic Hybridization Single-Nucleotide Polymorphism

2.Preimplantation Genetic Testing Market, By Procedure Type:

Preimplantation Genetic Screening Preimplantation Genetic Diagnosis

3.Preimplantation Genetic Testing Market, By Application:

Aneuploidy Structural Chromosomal Abnormalities Translocations Deletions Duplications Inversions Single Gene Disorders X-Linked Disorders HLA Typing Gender Identification

4.Preimplantation Genetic Testing Market, By Products And Services:

Reagents and Consumables Instruments Software and Services

5.Preimplantation Genetic Testing Market, By End User:

Maternity Centers & Fertility Clinics Hospitals, Diagnostic Labs, and Service Providers Research Laboratories & Academic Institutes

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The market is geographically spread across several key geographic regions and the report includes regional analysis as well as production, consumption, revenue and market share in these regions for the 2020-2027 forecast period. Regions include North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa.

Radical Coverage of the Preimplantation Genetic Testing Market:

Key Questions Addressed in the Report:

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Preimplantation Genetic Testing Market Potential Growth, Size, Share, Demand and Analysis of Key Players Research Forecasts to 2027 - The Daily...

Recommendation and review posted by Bethany Smith

In this report, the global Stem Cell-Derived Cells market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2025, growing at a CAGR of XX% during the period 2019 to 2025.

Persistence Market Research recently published a market study that sheds light on the growth prospects of the global Stem Cell-Derived Cells market during the forecast period (20XX-20XX). In addition, the report also includes a detailed analysis of the impact of the novel COVID-19 pandemic on the future prospects of the Stem Cell-Derived Cells market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Stem Cell-Derived Cells market to assist our clients arrive at beneficial business decisions.

The Stem Cell-Derived Cells market report firstly introduced the basics: definitions, classifications, applications and market overview; product specifications; manufacturing processes; cost structures, raw materials and so on. Then it analyzed the worlds main region market conditions, including the product price, profit, capacity, production, supply, demand and market growth rate and forecast etc. In the end, the Stem Cell-Derived Cells market report introduced new project SWOT analysis, investment feasibility analysis, and investment return analysis.

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Resourceful insights enclosed in the report:

The major players profiled in this Stem Cell-Derived Cells market report include:

key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

For any queries get in touch with Industry Expert @ https://www.persistencemarketresearch.co/ask-an-expert/28780

The market report addresses the following queries related to the Stem Cell-Derived Cells market:

The study objectives of Stem Cell-Derived Cells Market Report are:

To analyze and research the Stem Cell-Derived Cells market status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast.

To present the Stem Cell-Derived Cells manufacturers, presenting the sales, revenue, market share, and recent development for key players.

To split the breakdown data by regions, type, companies and applications

To analyze the global and key regions Stem Cell-Derived Cells market potential and advantage, opportunity and challenge, restraints and risks.

To identify significant trends, drivers, influence factors in global and regions

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the Stem Cell-Derived Cells market.

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Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 - 2029 - Stock Market Funda

Recommendation and review posted by Bethany Smith

DetailsCategory: AntibodiesPublished on Saturday, 03 October 2020 15:56Hits: 594

Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA in this setting1,2

Approval is based on CheckMate -743 in which Opdivo + Yervoy demonstrated superior overall survival vs. standard of care chemotherapy1

Approval marks third indication for Opdivo + Yervoy-based treatments in thoracic cancers and seventh indication overall

PRINCETON, NJ, UA I October 2, 2020 IBristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).1 This approval is based on a pre-specified interim analysis from the Phase 3 CheckMate -743 trial in which Opdivo + Yervoy (n=303) demonstrated superior overall survival (OS) versus the platinum-based standard of care chemotherapy (n=302) (Hazard Ratio [HR]: 0.74 [95% Confidence Interval [CI]: 0.61 to 0.89]; P=0.002), with a median OS (mOS) of 18.1 months (95% CI: 16.8 to 21.5) versus 14.1 months (95% CI: 12.5 to 16.2), respectively.1 These results were observed after 22.1 months of minimum follow-up.3 At two years, 41% of patients treated with Opdivo + Yervoy were alive and 27% with chemotherapy.1,3

Malignant pleural mesothelioma is a rare cancer with limited treatment options. When it is diagnosed in advanced stages, the five-year survival rate is approximately 10 percent, said study investigator Anne S. Tsao, M.D., professor and Section Chief Thoracic Medical Oncology and Director of the Mesothelioma Program at The University of Texas M.D. Anderson Cancer Center.2,4 The survival results from the CheckMate -743 trial show that the combination of nivolumab and ipilimumab could become a new front-line standard of care option. This is exciting news, instilling hope for patients with this devastating disease and for the healthcare providers who care for them.1,3

Opdivo and Yervoy are associated with Warnings and Precautions including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; complications of stem-cell transplant that uses donor stem cells (allogeneic); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1Yervoy is associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplant after Yervoy, embryo-fetal toxicity and risks associated when administered in combination with Opdivo.5 Please see the Important Safety Information section below.

This is the third indication for an Opdivo + Yervoy-based combination in the first-line treatment of a form of thoracic cancer.1Opdivo + Yervoy is approved by the FDA as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L11% as determined by an FDA-approved test, and without EGFR or ALK genomic tumor aberrations.1 It is also approved in combination with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations regardless of PD-L1 expression.1

Thoracic cancers can be complex and difficult to treat, and we are focused on developing immunotherapy options that may have the potential to extend patients lives, said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb.2,6 Just a few months ago, Opdivo + Yervoy-based combinations received two first-line indications for certain patients with non-small cell lung cancer. Now, Opdivo + Yervoy is approved for use in another type of thoracic cancer, previously untreated unresectable MPM. With todays announcement, Opdivo + Yervoy becomes the first new systemic therapy approved in more than 15 years in this setting, and may offer these patients a chance for a longer life. 1

Opdivo + Yervoy is a unique combination of two immune checkpoint inhibitors that features a potentially synergistic mechanism of action, targeting two different checkpoints (PD-1 and CTLA-4) to help destroy tumor cells: Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells discover the tumor.1,7 Some of the T cells stimulated by Yervoy can become memory T cells, which may allow for a long-term immune response.7,8,9,10,11,12 Targeting of normal cells can also occur and result in immune-mediated adverse reactions, which can be severe and potentially fatal.1 Please see the Important Safety Information section below.

This approval was granted less than six weeks following the submission of a new supplemental Biologics License Application (sBLA), which was reviewed under the FDAs Real-Time Oncology Review (RTOR) pilot program. The RTOR program aims to ensure that safe and effective treatments are available to patients as early as possible.13 The review was also conducted under the FDAs Project Orbis initiative, enabling concurrent review by the health authorities in Australia, Brazil, Canada and Switzerland.

About CheckMate -743

CheckMate -743 is an open-label, multi-center, randomized Phase 3 trial evaluating Opdivo plus Yervoy compared to chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with histologically confirmed unresectable malignant pleural mesothelioma and no prior systemic therapy or palliative radiotherapy within 14 days of initiation of therapy (n=605).1 Patients with interstitial lung disease, active autoimmune disease, medical conditions requiring systemic immunosuppression, or active brain metastasis were excluded from the trial.1In the trial, 303 patients were randomized to receive Opdivo 3 mg/kg every two weeks and Yervoy 1 mg/kg every six weeks; 302 patients were randomized to receive cisplatin 75 mg/m2 or carboplatin AUC 5 plus pemetrexed 500 mg/m2 in 3-week cycles for six cycles.1 Treatment in both arms continued until disease progression or unacceptable toxicity or, in the Opdivo + Yervoy arm, up to 24 months.1 The primary endpoint of the trial was OS in all randomized patients.1 Additional efficacy outcome measures included progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR), as assessed by BICR utilizing modified RECIST criteria.1

Select Safety Profile from CheckMate -743 Study

Treatment was permanently discontinued for adverse reactions in 23% of patients treated with Opdivo + Yervoy, and 52% had at least one dose withheld for an adverse reaction.1 An additional 4.7% of patients permanently discontinued Yervoy alone due to adverse reactions. Serious adverse reactions occurred in 54% of patients receiving Opdivo + Yervoy.1 The most frequent (2%) serious adverse reactions in patients receiving Opdivo + Yervoy were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism.1 Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis.1 The most common (20%) adverse reactions were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%) and pruritus (21%).1 The median number of doses was 12 for Opdivo and 4 for Yervoy.3

About Malignant Pleural Mesothelioma

Mesothelioma is a rare but aggressive form of cancer that often forms in the lining of the lungs.2,14 There are approximately 3,000 cases diagnosed in the United States each year.14 Malignant pleural mesothelioma is the most common type of the disease.2 It is most frequently caused by exposure to asbestosand diagnosis is often delayed, with the majority of patients presenting with advanced disease.2,15 Prognosis is generally poor: in patients with advanced malignant pleural mesothelioma, median survival is approximately one year and the five-year survival rate is approximately 10%.2

INDICATIONS

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), 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 overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Bristol Myers Squibbs Patient Access Support

Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.

BMS Access Support, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Supportat 1-800-861-0048 or by visiting http://www.bmsaccesssupport.com.

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens for patients with cancer in Japan, South Korea and Taiwan.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

References

SOURCE: Bristol-Myers Squibb

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US Food and Drug Administration Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously...

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Mathew Knowles, the father of music powerhouses Beyonc Knowles-Carter and Solange Knowles, on Saturday penned an opinion piece encouraging men to get tested for breast cancer.

Knowles wrote the op-ed for USA Today on the one-year anniversary of sharing his diagnosisof Stage 1A breast cancer and called for an inclusive term that doesnt embarrass men or prevent them from seeking the care they need.

It wasnt comforting to walk into my first oncology appointment through doors that read Womens Breast Clinic and to be greeted with the question, am Ihere for my wife? Knowles wrote. Since Ive shared my diagnosis, countless men have secretly shared their male chest cancer diagnosis with me, as they were too ashamed to talk openly about having breast cancer.

The music executive told Good Morning America last year that breast cancer affected several women in his family, including his aunt and cousins.

After his scheduled mastectomy, he learned that he had the BRCA2 gene mutation that put him at a higher risk of breast, prostate and pancreatic cancers and melanoma.

Im grateful to say Im cancer-free today and have the knowledge to make important lifestyle choices that hopefully keep me in remission, such as getting a mammogram every six months, Knowles wrote. Im perhaps even more grateful this discovery spurred my kids to take their own medical genetic tests to learn their own risks and better inform the decisions they make my newfound knowledge also became theirs.

He has since partnered with a medical genetics company, Invitae, and encouraged readers to get screenings done for gene mutations.

Its foolish that so few of us take advantage of this information thats more affordable and accessible than ever. Who doesn't want to be able to get ahead of potentially life-changing diseases or health conditions? Knowledge is power, he wrote.

There will be approximately 2,620 new cases of invasive breast cancer diagnosed in men in the year 2020, according to the American Cancer Society.

Breast cancer is about 100 times less common among white men than among white women.It is about 70 times less common among Black men than Black women, and Black men typically have a worse prognosis.

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Its one of the most important genes in biology: Sry, the gene that makes males male. Development of the sexes is a crucial step in sexual reproduction and is essential for the survival of almost all animal species.

Today in the journal Science, my international collaborators and I report the surprise discovery of an entirely new part of the Sry gene in mice a part we had no idea existed.

I co-discovered Sry in 1990. It is the gene on the Y (male) chromosome that leads to the development of male characteristics in mice, humans and most other mammals. Since then, Sry has been the subject of intense study worldwide because of its fundamental role in mammalian biology.

We have come to understand, in some detail, how Sry acts to trigger a cascade of gene activity that results in the formation of testes, instead of ovaries, in the embryo. Testes then stimulate the formation of other male characteristics.

But its clear we dont have all the answers just yet. Our results published today take us one step further in the right direction.

For 30 years, we have understood the Sry gene is made up of one exon, a segment of a gene used to code for amino acids, the building blocks of proteins. This can be compared to a computer file consisting of one contiguous block of data, on a hard disk.

Our newest research reveals theres actually a second exon in mouse Sry. This is like finding a whole new separate block of previously hidden data.

The mouse genome, like the human genome, has been extensively characterised due to the availability of advanced DNA sequencing and related technologies. Researchers commonly assume all the genes and all the parts of the genes have already been discovered.

But earlier this year, scientists in Japan uncovered what looked like a new piece of the Sry gene in mice. New sequencing approaches revealed what appeared to be two versions of Sry: a short, single-exon form and a longer, two-exon form. They called this two-exon version Sry-T.

They collaborated with my group at the University of Queensland and removed the new exon using CRISPR, a gene editing tool that lets researchers alter DNA precisely. Together we discovered this prevented Sry from functioning: XY mice (which would normally develop as males) developed as females instead.

Conversely, adding Sry-T to fertilised XX mouse eggs (which would normally develop as females) resulted in males.

Importantly, although human Sry does not have the added exon, our discovery may reveal new functions that might be shared between mouse and human Sry.

The DNA sequence of the new exon in Sry-T may point us towards discovering some of the genes and proteins that interact with Sry, something that has been elusive up till now.

And interactions we find in mice may also occur in humans. Studying what human Sry interacts with may help explain some cases of differences in human sex development, otherwise known as intersex development. This is a common but poorly understood group of mostly genetic conditions that arise in humans.

Currently, we dont know the genetics behind a large proportion of intersex conditions. This is partly because we dont yet know all the genes involved in the human sex development pathway.

Read more: Sex, genes, the Y chromosome and the future of men

Scientifically, this discovery is a bit like discovering a new cell type in the body, or a new asteroid in the Kuiper belt. As with many scientific discoveries, it challenges what we thought we knew and raises many questions.

What is the function of the new exon in Sry-T?

Currently, we only have part of the answer. It turns out the first exon of Sry, the one we already knew about, contains instability sequences at its end. These are sequences that cause proteins to fray and degrade.

An important function of the newly discovered second exon is to mask the instability sequences, seal the end of the Sry protein and prevent it from degrading. In other words, this second exon is crucial to the development of male babies.

Whats more, this protection mechanism represents an unusual and intriguing evolutionary mechanism that has acted to help stop vulnerable Y-chromosome genes from literally falling apart.

But its early days yet. The challenge now is to understand whether there are more functions hidden within the newly discovered exon.

If so, this information may provide some of the missing links that have stood in the way of our full understanding of how Sry works at a molecular level and of how males and females come to be.

Read more: Why education about gender and sexuality does belong in the classroom

Read more:
We discovered a missing gene fragment that's shedding new light on how males develop - The Conversation AU

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If youre a parent, you know the thoughts, feelings and emotions that come with protecting your child. Youd do anything for them to ensure they live a long, healthy life. But what will you do when there are times when health conditions, such as childhood cancer, stand in the way?

Cancer in children is more common than you may think, as it accounts for the second-leading cause of death behind accidents. While a cancer diagnosis, or even the thought of your child developing cancer one day, is overwhelming, modern medicine has improved survival rates. As with any cancer, early detection is key. To help you familiarize yourself with childhood cancer, we asked Michael Confer, M.D., a radiation oncologist at the INTEGRIS Cancer Institute, about the different types of cancers, which signs to look for and how they can be treated.

Unlike adult cancers, which can result from the environment or exposure to certain things, childhood cancers result from genetic mutations that occur early on in life or before birth.

It all comes down to changes in genes. Your DNA contains information to make different types of cells in your body. In other words, your skin cells contain information to be brain cells, while your kidney cells contain information to be heart muscle cells. As cells mature, they become specialized, turning on and off certain genes to allow them to perform specific duties. Cells need to be able to replicate to replace damaged cells of the same category. They grow with help from genes called proto-oncogenes.

When your DNA changes, it leads to genetic mutations, and cells can become permanently activated. This can lead to cells duplicating uncontrollably, known as cancer.

Tumor suppressor genes slow down cell division. They repair DNA mistakes before cells divide and control cells internal death process (apoptosis or programmed cell death), Dr. Confer says. DNA mutations within tumor suppressor genes can also allow cells to duplicate uncontrollably. Children can be born with mutated proto-oncogenes or tumor suppressor genes in certain cells. These abnormally programmed cells lead to most childhood cancers.

So, what causes DNA changes? Your child can inherit genes from a parent that increases their risk of cancer or they can acquire these genes. Cancers from acquired, sporadic gene mutations are more common than those from inherited gene mutations 5% of all childhood cancers come from inherited mutations.

Breast cancer and ovarian cancer are the most common types of cancer caused by inherited DNA changes from BRCA1 or BRCA2 gene mutations. Even with how well-known these are, only 5 to 10% of breast cancer cases come from BRCA1/BRCA2 inherited mutations. Plus, breast cancer and ovarian cancer are more common in adults than children. Talk to your doctor or visit a genetic counselor if you have specific questions about inherited mutations.

Cancer can impact any part of your body, ranging from your bones and blood cells to your brain, spinal cord and other internal organs. You may be most familiar with leukemia, lymphoma, and brain and spinal tumors, since they are the most common. But, here is a full overview of cancers that commonly affect children, according to the American Cancer Society.

Leukemia: This is the most common type of cancer in children, accounting for 28% of cases. It generally starts in white blood cells and becomes fast growing (acute). Acute lymphocytic leukemia (ALL) and acute myeloid leukemia (AML) are the two most common types of leukemia. Three out of every four children with leukemia have ALL. This type of cancer starts in the lymphoid cells, called lymphocytes, whereas AML starts in myeloid cells. Chronic myeloid leukemia (CML) and chronic lymphocytic leukemia (CLL) are two types of rare cancers

Brain and spinal cord tumors: These types of cancers make up 26% of all cases. Brain tumors are more common than spinal cord tumors. The cancer generally starts in the lower part of the brain.

Neuroblastoma: This type of cancer affects infants and young children. Neuroblastoma starts in nerve cells during pregnancy and accounts for 6% of childhood cancers. Abdomen swelling is a common sign of neuroblastoma.

Wilms tumor: This type of cancer starts in the kidneys and impacts children who are 3 or 4 years old. It accounts for 5% of childhood cancers.

Lymphoma: Although lymphoma isnt as common as other types of cancers, youve likely heard of Hodgkin lymphoma and non-Hodgkin lymphoma, the two main types of cancer that show up in the lymphocytes. Non-Hodgkin lymphoma (accounts for 5% of childhood cancers) appears in younger children and is more common than Hodgkin lymphoma (accounts for 3%), which is more common in younger adults. You may notice a swollen lymph node under your childs arm or near their throat.

Rhabdomyosarcoma: This type of cancer develops in areas that your child uses to move their body, such as the head, pelvis, arms or legs. It accounts for 3% of childhood cancer cases.

Retinoblastoma: This cancer develops in the eyes, and your child is most at risk around the age of 2 until the age of 6. It accounts for 2% of childhood cancers.

Bone cancer: Bone cancer is more prominent in teens, but it still accounts for 3% of childhood cancers. There are two types, osteosarcoma and Ewing sarcoma, that show up via swelling around the bones. Ewing sarcoma is a less common type of cancer that is more prominent in older children and younger teens. Osteosarcoma, meanwhile, is more common in teens and in areas where bones grow quickly.

There isn't a one-size-fits-all guide to know if your child has cancer. In general, Dr. Confer says to keep an eye on any changes in your childs behavior, such as walking, eating, playing or sleeping. If theyre older, listen to any complaints they may have. Some cancers may produce a lump or swelling and pain in certain areas. Other symptoms include a loss of energy, weight loss, sudden eye or vision changes, frequent headaches with vomiting or a persistent fever that signifies the body is fighting an infection.

For example, leukemia, the most common type of childhood cancer, affects most children between the ages of 2 and 4. Typical symptoms include fever, bleeding, deep pain in the bones, small red spots on the skin called petechiae, bruises and enlarged lymph nodes.

Notify your childs pediatrician if any of these concerns arise. Aside from that, you should schedule your child for routine checkups and wellness visits.

Routine checkups and wellness visits help monitor normal growth and development. A good pediatrician-patient relationship helps the physician better identify subtle signs of cancer and gives parents a trusted sounding board for the concerns parents or children may have, Dr. Confer says.

Many childhood cancers have become increasingly treatable, leading to longer survival rates. Dr. Confer says acute lymphoblastic leukemia, lymphoma or kidney tumors known as Wilms tumor all have more than a 90% five-year survival rate (the percentage of patients who are alive five years after receiving treatment or a diagnosis).

In fact, the overall five-year survival rate for childhood cancers has improved from 58% in the mid-1970s to 84%, according to the American Cancer Society. But, certain types of aggressive cancer still exist. Diffuse intrinsic pontine glioma (DIPG), a rare brain tumor, is often cited as the childhood cancer with the poorest survival rate (less than 1% for five years).

No matter the diagnosis, continual hope and quality, proven therapies are the most important factors for children and families facing childhood cancers, Dr. Confer says.

Here are some of the most common forms of therapies to treat childhood cancer.

Surgery can help many patients, whether you need an entire tumor removed or a procedure to ease pain caused by a tumor. Your childs surgeon can also debulk a tumor, meaning they remove part of it and treat the rest with another method. Surgery has the highest success rate when its contained to one area, before the cancer has an opportunity to metastasize (spread to other parts of the body).

High doses of radiation help reduce cancer by either killing the cells or damaging their DNA to slow growth. Over time, these cells die and your body removes them. You can either receive internal or external radiation. External radiation comes from a beam that treats a specific body part, whereas internal radiation is in solid or liquid form. More specifically, brachytherapy is the medical term for solid internal radiation. Your doctor will place capsules, seeds or ribbons near the tumor. Systemic therapy is the medical term for liquid internal radiation. With this method, the radiation travels through your blood via a pill, injection or IV to kill cancer cells.

Chemotherapy comes in many methods of application, such as IV, oral, injection, topical or through a catheter, port or pump. Chemotherapy also kills healthy cells, which is one of the downsides. This is why many chemotherapy patients lose their hair and experience other side effects. Depending on the type and progression of the cancer, chemotherapy can help shrink a tumor to increase the success rate of surgery or radiation. Chemotherapy can also fight against any lingering cancer cells following surgery or radiation. Its also used to treat cancer that returns or metastasizes.

The immune system is your bodys way of defending itself against harmful germs, bacteria and viruses. When it comes to cancer, the immune system can have trouble recognizing and fighting off harmful cells because cancer starts in healthy cells. Immunotherapy helps your body pinpoint cancer kills to better defend against them. There are many types of immunotherapy treatments to boost your immune system. One type, chimeric antigen receptor (CAR) T-cell therapy, mixes your own T-cells with a virus that teaches the T-cells how to kill cancer cells.

Targeted therapy is a form of chemotherapy. But, as the name suggests, these drugs zero in on a specific area of the cancer cells. Depending on the drug, targeted therapy can change the protein levels in cancer cells or block chemical signals that help cancer cells grow. Other targeted therapy drugs can limit blood vessel production to cut off the cancer cells or distribute toxins to specifically kill the cancer while sparing healthy cells.

Stem cells, which originate in the bone marrow, make red blood cells, white blood cells and platelets. Leukemia and lymphoma start in the blood cells, causing damage to the cells your body needs to function. A stem cell transplant involves destroying cancer cells via chemotherapy and/or radiation before replacing them with new, healthy cells. This allows doctors to use stronger doses of chemotherapy or radiation knowing new cells, via a transplant, will replace old, damaged cells. Stem cell transplants can come from your own cells or the cells of another person. Donated cells are often more effective since they can help kill off cancer cells.

While you cant do anything to prevent your child from developing cancer, you can be proactive by scheduling regular checkups and looking out for warning signs and symptoms. Contact an INTEGRIS pediatrician if you have any concerns, and they can refer you to an oncologist at the INTEGRIS Cancer Institute.

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WASHINGTON, D.C. (WCBD) Dr. Sean P. Conley, Physician to the President, on Friday announced that President Donald Trump is receiving treatment for COVID-19 after testing positive for the virus early Friday morning.

Conley said that POTUS received a single 8-gram dose of Regenerons polyclonal antibody cocktail via infusion.

President Trump is also taking zinc, vitamin D, famotidine, melatonin, and a daily aspirin, according to the letter. It is unclear whether this regiment is related to his COVID-19 diagnosis.

According to the National Institutes of Health, zinc is a natural mineral and immunity booster often used to reduce the severity and duration of cold symptoms.

Vitamin D, most often associated with sunlight, may be used for the reduction of inflammation as well as modulation of such processes as cell growth, neuromuscular and immune function, and glucose metabolism, according to the National Institutes of Health.

Famotidine is a heartburn relief and acid-reducing drug.

Melatonin is a naturally occurring hormone often taken as a sleep aid.

Aspirin is taken for a variety of reasons. It can serve as an anti-inflammatory, fever reducer, pain reliever, and blood thinner.

Despite feeling fatigued, Conely reports that the President is in good spirits.

First Lady Melania Trump also tested positive and is experiencing mild symptoms as well. There is no word on whether the First Lady has received treatment.

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POTUS being treated with antibody cocktail, according to letter from his physician - WCBD News 2

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President Donald Trump has now received two experimental treatments for his coronavirus infection, a combination that doctors say is logical but untested.

After being flown to Walter Reed Medical Center, President Donald Trump received an IV infusion of the antiviral drug remdesivir, the White House physician said Friday night. He previously got a dose of an experimental antibody cocktail.

After testing positive for the coronavirus, Trump had a fever, a mild cough, nasal congestion, and fatigue, Conley said. The timeline on when exactly the president tested positive was not immediately clear, but Conley said the COVID-19 diagnosis was confirmed via testing on Thursday.

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Shortly after Conley provided an update on Trump's health Saturday, an anonymous source familiar with the president's health appeared to contradict the physician's assessment.

"The thought is if you can reduce the viral burden with an antiviral early on, then maybe the progression will be halted in some way," Dr. Mangala Narasimhan, an intensive care doctor who oversees ICU care at Northwell Health, told Business Insider on Saturday.

"Given the fact he's 74, a male, and obese, I think he's in a higher-risk category, so his chances of getting sick from this are higher," she added. "They are trying to prevent that from happening"

The antibody treatment is made by the biotech company Regeneron and is not approved by the FDA. The experimental treatment aims to boost the body's immune response to help in fighting the virus.

Read more: Trump just received Regeneron's experimental COVID-19 treatment. Here's the inside story of the biotech and its 2 billionaire founders.

"We are clearly in a data-free zone right here," Dr. Taison Bell, an infectious-disease and critical-care physician at the University of Virginia's medical center told Business Insider on Saturday. "What his medical team is doing is trying what they can. The more we learn about these different combinations, the more we'll be informed. Right now, it's kind of like we're driving in the dark."

"It's right at that cusp where someone is sick or starting to get sick, but they aren't quite super sick," said Bell, who was a principal investigator for a National Institutes of Health trial that tested remdesivir.

Read more: Trump got a dose of Regeneron's experimental coronavirus treatment. Here's how the biotech and 8 others are racing to develop new ways to fight COVID-19.

Both physicians emphasized the lack of publicly available, detailed information on Trump's health.

Bell and Narasimhan both said there is no reason to not believe the health reports are accurate.

A possible sign that Trump's condition is worsening would be if he begins to receive steroids, the doctors said.

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Trump's doctors are targeting a 'sweet spot' in fighting COVID-19 by using experimental treatments early, but - Business Insider India

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By Deena Beasley and Diane Bartz

(Reuters) - President Donald Trump has been treated with an experimental antibody cocktail for COVID-19 and is moving to a military hospital as a precautionary measure, White House officials said on Friday.

The president's physician, Dr. Sean Conley, said in a statement that Trump "remains fatigued but in good spirits" after receiving an intravenous dose of Regeneron Pharmaceuticals Inc's dual antibody. Trump was also taking immune system boosters zinc and vitamin D, aspirin, and other generic drugs.

Trump, 74, walked to a helicopter on Friday before being moved to a special suite at Walter Reed National Military Medical Center in Bethesda, Maryland, for the next few days.

Regeneron's drug, REGN-COV2, is part of a class of experimental COVID-19 drugs known as monoclonal antibodies: manufactured copies of human antibodies to the virus that are being studied for use in patients with early illness.

Trump's doctors "must be sufficiently concerned with what they are seeing that they decided to use an experimental medicine ... Experimental drugs are by definition risky," said Dr. Edward Jones-Lopez, infectious disease specialist at the Keck School of Medicine of the University of Southern California in Los Angeles.

Antibodies are proteins made by the body's immune system that recognize, bind and neutralize an invading virus. Regeneron's cocktail - which contains an antibody made by the company and a second isolated from humans who recovered from COVID-19 - is designed so that its two antibodies bind to the coronavirus' spike protein, limiting the ability of viruses to escape.

The technique is already in wide use for treating a range of illnesses. Data so far is limited for COVID-19 antibodies, but U.S. infectious disease chief Dr. Anthony Fauci is among those saying it has promise.

Regeneron this week reported trial results showing that its drug improved symptoms in non-hospitalized COVID-19 patients, with no serious side effects, and said it planned to talk with the Food and Drug Administration (FDA) about an emergency use authorization.

Eli Lilly & Co has also announced encouraging early data from a trial of its coronavirus antibody, and said it is seeking an emergency authorization from the FDA.

Shares of Regeneron rose about 3% in after hours trade, following the announcement that Trump was given the drug.

Trump is also taking the heartburn drug famotidine - often sold in the U.S. under the brand name Pepcid. Although the drug has not been shown to work against COVID-19, researchers are studying it as a possible treatment.

Zinc and vitamin D are believed to boost the immune system. Melatonin is a hormone that helps to regulate daily body rhythms. Trump has said in the past that he takes a daily low-dose aspirin, which is recommended for some adults at increased risk of heart attack or stroke.

(Reporting by Deena Beasley and Diane Bartz; Additional reporting by Michael Erman; Editing by Jonathan Oatis, Daniel Wallis and Peter Henderson)

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The aggressiveness of early breast cancer and the overall prognosis of patients with the disease is highly dependent on the presence of aberrations in the tumor. HER2 overexpression, in particular, is found in 10% to 40% of breast tumors, which make tumors with these characteristics less responsive to the hormone therapy and cytotoxic agents most commonly used for the treatment of breast cancer.1

Although HER2 positivity has been identified as a predictive factor of response to chemotherapy, it remains controversial considering that responses to chemotherapy can vary in patients with certain disease characteristics. Once trastuzumab (Herceptin), the first targeted therapy for HER2-positive breast cancer entered the paradigm, it was clear that patients had more options,1,2 but, experts were unaware of how far targeted therapies could go in terms of improving outcomes.

Treatment should be individualized based on the patients presenting characteristics, including tumor size, lymph node status, and hormone receptor status, Kari B. Wisinski, MD, medical oncologist, UW Health and the University of Wisconsin Carbone Cancer Center, told Targeted Oncology, in an interview.

Individualizing therapy for our patients with HER2-positive disease can help us improve outcomes and decrease toxicity for our patients, added Sara Tolaney MD, MPH, associate director, Susan F. Smith Center for Women's Cancers, director, Clinical Trials, Breast Oncology, and senior physician, at the Dana-Farber Cancer Institute, and assistant professor of medicine, at Harvard Medical School.

Before the Agent Boom in HER2-Positive Breast Cancer

As a newly introduced targeted therapy in the field of HER2-positive breast cancer in 1998, trastuzumab added to cytotoxic chemotherapy demonstrated a significant improvement in disease-free survival (DFS) in patients with HER2-positive breast cancer, according to results from the N9831 trial (NCT00005970). The result was a 10-year DFS rate of 73.7% with the addition of trastuzumab compared with 62.2% with chemotherapy alone (HR, 0.60; 95% CI, 0.53-0.78) and the 10-year OS rate achieved was 84% versus 75.2% (HR, 0.63; 95% CI, 0.54-0.73).3

As scientific advances were made, trastuzumab continued to be used with chemotherapy, but novel targeted therapies also emerged in the landscape.2

The Thriving Targeted Therapy Research in HER2-Positive Breast Cancer

Many targeted therapies are now FDA approved as treatment of patients with early HER2-positive breast cancer and, unsurprisingly, many of the regimens used in clinical trials for these patients include trastuzumab or are intended to be administered after trastuzumab treatment is completed.

Several new targeted therapies have emerged in the last several years for HER2-positive breast cancer. First of all, we have pertuzumab [Perjeta], the anti-HER2 monoclonal antibody, which has been supported in the neoadjuvant setting as well as in the adjuvant setting. There is neratinib [Nerlynx], which is an oral tyrosine kinase inhibitor that is now approved as an extended duration anti-HER2 treatment following completion of 1 year of trastuzumab in the adjuvant setting, Wisinski explained.Lastly, we have recent data for T-DM1 [trastuzumab emtansine; Kadcyla], which is now FDA approved in the post-neoadjuvant setting in patients with residual disease after standard upfront chemotherapy and anti-HER2 directed therapy. Each of these 3 medications has significantly changed our landscape.

One of the most revolutionary clinical trials exploring the use of novel targeted therapies in patients with breast cancer is the I-SPY-2 platform trial, which includes a subset of patients with HER2-positive disease. I-SPY-2 is a series of mini studies of novel drugs combined with chemotherapy compared with single-agent standard of care, which is the combination of paclitaxel plus trastuzumab followed by doxorubicin and cyclophosphamide. The trial includes 4000 patients.

The combination treatment arms being explored in I-SPY-2 include AMG 386 with or without trastuzumab, AMG 479 (Ganitumab) plus metformin, MK-2206 with or without trastuzumab, T-DM1 plus pertuzumab, pertuzumab plus trastuzumab, talazoparib (Talzenna) plus irinotecan, patritumab plus trastuzumab, durvalumab (Imfinzi) plus olaparib (Lynparza), and cemiplimab (Libtayo) plus durvalumab plus olaparib. The monotherapy arms include ganetespib, ABT-888, neratinib, PLX3397, pembrolizumab (Keytruda), SGN-LIV1A, tucatinib (Tukysa), and cemiplimab, in all breast cancers.4

Aside from the I-SPY-2 trial, vaccine therapies including the HER2-sensitized dendritic

cell vaccine (NCT0338755), the dendritic cell vaccine compared to the WOKVAC vaccine (NCT03384914), and TPIV100, another HER2 vaccine (NCT04197687) are under investigation in phase 1/2 clinical trials.

There have also been studies of combination chemotherapy like trastuzumab plus chemotherapy (NCT03894007), which is a phase 2 study evaluating treatment before surgery in patients with HER2-amplified early breast cancer. Therapeutic strategies that are even further along in the pipeline are immune checkpoint inhibitor monotherapy and immunotherapy and chemotherapy combination that first demonstrated efficacy in other diseases.

The immunotherapy agents and combinations currently under investigation for early HER2-positive breast cancer include the phase 2, open-label, randomized, multicenter trial of paclitaxel plus pembrolizumab versus pembrolizumab alone (NCT03747120); the phase 2 trial of doxorubicin, cyclophosphamide, and paclitaxel plus nivolumab (Opdivo; NCT03742986) in inflammatory breast cancer, which includes patients with HER2-positive disease in 1 arm who will be treated with added trastuzumab and pertuzumab; as well as the single-arm, open-label study of M7824 ahead of standard neoadjuvant therapy (NCT03620201), which is evaluating patients with stage II or III HER2-positive breast cancer.

Expanding the Possibilities of Trastuzumab

Trastuzumab is considered a standard chemotherapy backbone in the landscape of HER2-positive breast cancer.1 To keep the efficacy going, Wiscinski suggests using trastuzumab not only to escalate but also to de-escalate treatment.

One of the strategies that still needs to be considered is not just escalating treatment with these newer agents, but also the idea of deescalating for smaller HER2-positive breast cancer. In particular, I am thinking about either the regimen of paclitaxel with trastuzumab or T-DM1 as a single-agent, Wiscinski stated. Overall, the escalation treatment strategy is sometimes appropriate, but other times, de-escalation is a critical thing for treating HER2-positive breast cancer.

Tolaney also noted, during an interview, that de-escalation plays a critical role in how patients with HER2-positive breast cancer are treated.

By tailoring adjuvant therapy based on response to preoperative therapy, we are able to escalate therapy for patients with residual disease, and de-escalate for patients with pathologic complete response, Tolaney stated.

The de-escalation strategy is an area of active research as well. Currently, the CompassHER2-pCR study (NCT04266249), the PALTAN study (NCT02907918), and the TOUCH trial (NCT03644186) are all investigating de-escalation of trastuzumab-containing regimens.

Wiscinski noted, however, that challenges do exist with this strategy and should be explored future.

An unmet need is having better predictors of who needs an escalation treatment and who can have their treatment de-escalated. For example, right now we rely a lot on nodal status and tumor size, but there could potentially be genomic markers or diagnostic tests that could help us identify which patients have very HER2-sensitive disease and potentially could be treated with less chemotherapy, she explained.

References:

1. Kurebayashi J. Biological and clinical significance of her2 overexpression in Breast Cancer. Breast Cancer. 2001;8(1):45-51. doi:10.1007/BF02967477

2. Sharifi M, Wisinski KB. Advances in the treatment of early-stage her2-positive breast cancer. Clin Adv Hematol Oncol. 2020;18(8):482-492.

3. Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32(33):3744-3752. doi:10.1200/JCO.2014.55.5730

4. The I-SPY 2 Trial. I-SPY2 website. Accessed October 2, 2020. https://bit.ly/36qn2Kk

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Trastuzumab-Containing Regimens and Novel Drugs Mark the Precision Medicine Era of HER2-Positive Breast Cancer - Targeted Oncology

Recommendation and review posted by Bethany Smith

HACKENSACK, N.J. One year ago, despite having had a negative mammogram and ultrasound four months earlier, 67-year-old Doris Barnhill of Cliffside Park did a quick dance of her fingertips around her breasts to feel for lumps anyway until she stopped at what felt like a pea-sized marble beneath her skin in one of them.

The following week, Barnhill made an appointment with her primary care physician who referred her back to a breast specialist who saw her that day. Last September, she was diagnosed with Stage III Triple Negative Breast Cancer. According toBreastCancer.org, this type of breast cancer, found in 10-20% of patients, tests negative for estrogen and progesterone receptors and excess HER2 protein, meaning the cancer is not triggered by these hormones nor the HER2 protein and thus does not respond to hormonal therapy medicines or the ones that target HER2 protein receptors. However, other medicines are used to successfully treat it.

It took me over the edge, said Barnhill through her pink surgical mask at a table outside Hackensack University Medical Centers Breast Cancer Awareness Month kickoff event Thursday, organized by the Betty Torricelli Institute for Breast Cancer. Hearing that for the first time was devastating for me because I lost a sister, so all I could see was, This is it. I couldnt see past the fact that its breast cancer. She didnt survive, why would I?"

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Barnhill had lost her estranged sister, Dolores, to breast cancer 15 years ago just two years after she was diagnosed. While the circumstances surrounding her sisters condition remain unclear, Barnhill says shes glad she advocated for herself when her body told her something felt off. And breast specialists at Hackensack University Medical Center, where Barnhill is currently being treated, agree.

You never want tobe cavalier and ignore something, said Dr. Gail Starr, Chief of Breast Imaging at Hackensack UMC. You should always bring it to medical attention and have it evaluated.Early detection is the key to finding things earlier , when theyre more treatable , and you have less aggressive treatment options."

Any noticeable changes in a womans breasts merit a trip to the doctor, Starr said, especially changes in the areola like flakiness, clear or bloody discharge from the nipple, and of course, firm lumps. Barnhill received chemotherapy at the John Theurer Cancer Center at Hackensack UMC in Edgewater closest to her home. While she was scheduled for a mastectomy this past May, her surgery was on hold whenshe was diagnosed with Covid-19 on April 10 when the virus which has to date claimed more than 1 million lives around the world was at its apex. Barnhill was five days shy of her last chemotherapy treatment when she was diagnosed with the potentially deadly virus.

I just could not get up, she recalled of her symptoms.

Apart from chronic fatigue caused by the highly contagious virus affecting the respiratory system, she had been experiencing bouts of nausea and vomiting. While her Covid diagnosis temporarily derailed her cancer treatment, the mother of three and soon-to-be grandmother of five decided to stay positive and applied the same optimistic attitude she used to power through her cancer diagnosis to get her through Covid.

I refused to give up, she said. My attitude was such that I came through my chemo treatments with flying colors. I remember there was hair loss and skin discoloration. In terms of how I felt when undergoing chemo, I didnt have those issues. I continued to work. I did everything I needed to do.

Because Barnhills cancer was more aggressive, she wound up going in for surgery in May despite having had the virusstill. Her Covid-19 test was negative the following month. After overcoming Covid, Barnhill completed her radiation treatments following her mastectomy and is currently on pill therapy, which she will continue for the next five years. A retired manager for a health care plan working in the customer service division, Barnhill continues her lifes purpose of serving to interact with others to teach everyone with whom she comes in contact diplomatic relations so they walk away feeling like they were treated with respect and dignity, she says.

Similarly, at Hackensack UMC, the same can be said of the hospital staff who she said continue to assume the role of her cheerleader throughout her cancer journey.

You dont feel like youre another cancer patient coming in, said Barnhill. Its been so very personal. Im just not accustomed to people as personable as they are and constantly assuring you. I initially didnt have any hope.

While many newly diagnosed cancer patients can feel that way, treatment options are promising provided early detection. While genes can play a role in ones development of breast cancer, physicians say a number of patients dont have any risk factors or family members diagnosed. Breast specialists say being female alone and older age significantly increase your risk, in addition to younger women carrying the BRCA gene.

Patients who are considered high-risk classically are the patients who carry the genetic mutations of the BRCA 1 and 2 breast cancer mutation genes, explained Dr. LeslieMontgomery, a surgical oncologist specializing in breast cancer at the hospital. People with a strong family history of breast or ovarian cancer. Women who have had radiation very young in life sometimes for lymphoma. People who get radiation to their breasts in their teens and 20s. Those are the people who are at very, very high-risk and we follow them in high-risk programs and do additional imaging and do an even earlier than the average person who starts getting mammograms or MRIs. There are also certain types of pathology that we see on breast biopsies that will make people high risk. But even a person with a first-degree relative a mother, a daughter or a sister who has breast cancer is considered higher risk than the average population.

A woman who has a grandmother who had breast cancer could also contract cancer if her father carries a breast cancer gene, she said. For women who have a history of breast cancer in her family, with multiple members having had the disease, genetic testing is recommended to test for the nine genes associated with the cancer via a simple blood test performed by her gynecologist.

While other risk factors such as having dense breasts, or breasts with more glandulartissue than fat, and a woman having her first child after age 30 can also increase ones risk for the disease, doctors agree that limiting alcohol consumption in addition to quitting smoking can also help to reduce ones risk for developing breast cancer. A healthy lifestyle in addition to post-menopausal women remaining at a healthy weight by incorporating a personalized exercise regimen on top of following a healthy diet are also ways toprevent most other diseases including heart disease, another top killer of women, especially African-American.

I think everything in moderation is a good strategy, said Montgomery. With respect to preventing breast cancer, I think all of us need to recognize that women are 10 times more likely to die of heart disease in this country than we are to die of breast cancer. And I think for some reason we may make so much effort to try to prevent breast cancer, but obesity, hypertension, diabetes, these are the things that are really killing us in terms of heart disease. I do agree with not gaining weight, drinking alcohol in moderation, exercising, the things are also very beneficial in reducing heart disease so they go hand in hand.

Dr. Starr recommends women begin having annual mammograms at 40, and for those who test positive for the BRCA gene to test 10 years sooner than that.

Most patients dont carry the gene, said Starr of the women diagnosed. Being a woman and getting older are the two most common risk factors you cant change or do anything about.

She said if women do test positive for the BRCA gene, having a mastectomy is one way to reduce her risk for developing breast cancer in the future. However, having one does not guarantee breast cancers prevention.

Having mastectomies does not make your risk zero, said Starr. Theres still always a small risk because there are cells underneath the skin and against the chest wall. But it does decrease your risk significantly."

Starr added that if women do have the BRCA gene, the best approach is seeing a breast specialist and oncologist who can explore breast imaging and hormone therapy as preventative treatment options.

In addition to the Prospect Avenue hospitals Breast Cancer Awareness and Risk Evaluation Program, Hackensack UMC also offers cutting-edge technology for detection, including 3-D imaging which allows doctors a clearer viewing of any hidden tumors, which lead to a reduced need for further biopsies.

As for Barnhill?

I feel great, she said. I feel healthy. Ive survived a lot. When I take a minute to think about what Ive gone through based on my original diagnosis where I had no hope to get to the point where I am now I cant give up.

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'I Refused To Give Up.' This Woman Was Diagnosed With Stage 3 Breast Cancer Then Covid Months Later. How She Survived - TAPinto.net

Recommendation and review posted by Bethany Smith

Oral contraceptive pills are the most commonly used method of hormonal contraception in the United States. According to the National Survey of Family Growth conducted in 2015-2017, 80.5% of reproductive-aged women who had ever been sexually active had used oral contraceptive pills (OCPs) at some point.

A survey of reproductive-aged women who have ever been sexually active found that 12.6% currently use pills.1

There are two general types of OCPscombined oral contraceptives (COCs), which contain both ethinyl estradiol (EE) and progestin, and progestin-only pills (POPs). Current COCs offer a range of doses and progestins to choose from.2

COCs are a moderately effective method of contraception. They have a perfect use failure rate of <1% and a typical use failure rate of 9%.3 Several clinical trials have quoted failure rates of POPs between 1-13% in the first year.4-7

Little data is available directly comparing the efficacy of different types of progestins; however, a few studies suggest no difference.5,6 It is likely that typical use failure rates are higher in POP users due to the strict dosing timeframe, including recommendations to take the pill within a 3-hour window.3

EE and progestin each work separately, as well as synergistically, to provide contraceptive benefit. EE mainly works by suppressing the release of follicle-stimulating hormone (FSH) from the pituitary, which hinders folliculogenesis.

It is also suggested that EE causes endometrial edema, which affects implantation. EE has an added benefit of stabilizing the endometrium, which reduces spottinga favorable effect. As EE potentiates the effects of progestin, smaller doses of progestin may be used in COCs.8

Progestin works in three major ways: 1) it suppresses GnRH release from the hypothalamus, decreasing LH and FSH release; 2) it prevents the LH surge from the pituitary, which prevents ovulation; and 3) it thickens cervical mucus, which impedes sperm entry into the uterus.

There may be some inhibition of peristalsis and tubal mobility as well. Progestin causes endometrial atrophy, which impairs implantation. Each progestin has a different potency and dose for which it blocks ovulation. POPs rely on these multiple mechanisms to prevent pregnancy.8

Although oral contraceptives are a great choice for many women, it is important to understand the conditions that may increase risk for the user. We will outline some of the risks below and the CDC Medical Eligibility Criteria chart can be referenced for more information.9

It is important to remember that the risks and benefits must be weighed for each woman individually and that in most cases, pregnancy is more dangerous than pill use.

In patients who have conditions in which pregnancy would increase their risk of adverse health outcomes (Table 1), long-acting reversible contraception (LARC) may be the best choice to avoid unintended pregnancy.10 It is also important to review a patients medication history, as there may be drug interactions that reduce efficacy of COCs and POPs.9

EE is pro-coagulable and is contraindicated in a number of situations. Progestin also has risks to the user. Providers should screen for personal or family history of venous thromboembolism, as this increases coagulation risk in COC users.

Additionally, because of hypercoagulability in the postpartum state, COCs should not be used until 6 weeks after childbirth. Women who smoke and are over age 35, women with migraine with aura, or those who have uncontrollable hypertension or vascular disease are at increased risk of stroke and should not use estrogen-containing methods.9

There are self-screening tools available to check for COC eligibility, such as the one used in a study by Grossman et al, which showed a sensitivity of 83.2% and specificity of 88.8% in patients using the survey to determine true contraindications to COC use.11 These tools can be helpful to both providers and patients, particularly as we increase use of telemedicine (Table 2).

As with any medical decision, it is exceptionally important to utilize shared decision-making in choosing the right contraceptive method for each patient, which should improve satisfaction, encourage compliance, and reduce unintended pregnancy.

Shared decision-making involves the patient and provider working together to make a decision through discussion of all options while taking patient preference into account.12

Because there are many contraceptive options available, it is important to discuss values (including the acceptability of an unplanned pregnancy if there is a contraceptive failure), beliefs, dosing frequency, financial considerations, and risks and benefits of each method.

Other considerations include how often women want to have withdrawal bleeding, and desired benefits such as improvement in dysmenorrhea, acne, and mood symptoms. All women should be provided with a multiple-month prescription to improve medication adherence.

As with any method, there are side effects of COCs and POPs that are important to discuss with patients as they decide which method is best for them. Of women who have ever discontinued using COCs or POPs, 34% reported that they were dissatisfied and 64.4% stopped due to side effects.1

Some common side effects to discuss with women are breast tenderness, nausea, bloating, and breakthrough bleedingall of which often improve or completely resolve after the first several months.13 Women may not always discuss their choice to stop taking COCs or POPs, making it essential for clinicians to ask about the experience of past side effects, as well as to provide preventive guidance about the possibility of side effects before starting a new method.

Once a woman and her provider have decided on using COCs, there are multiple options. Patients desiring a withdrawal bleed may prefer a pill pack with monthly placebo pills, while patients desiring fewer menses prefer continuous use without placebo pills and may opt for extended cycle use.

Additionally, providers may identify other co-existing conditions that may be treated with COCs such as acne, undesired facial hair growth, bloating, and/or headaches. COCs can also help reduce risk of ovarian cysts, fibroids, and benign breast disease.14

As mentioned earlier, all COCs have a progestin and EE component and doses differ by pill type. COCs have a range of EE between 10-35 mcg.

A systematic review showed higher discontinuation rates for COCs with lower doses of EE, due to side effects such as breakthrough bleeding. To reduce estrogenic risks, it is reasonable to start at 20 mcg EE and increase if necessary,15 although for adolescents, data supports using a dose of 30 mcg EE or greater as lower doses of EE have been associated with impaired bone acquisition.16,17

Providers should consider the progestin component of the COC, or which progestin to use on its own in a POP, as this may result in undesired side effects.2,18-20

Some progestins are noted to have androgen-like effects, with users reporting oily skin, facial hair growth, or acne. Of note, all COCs have been shown to help with acne, but it is reasonable to choose a pill with a less androgen-like progestin and/or higher estrogen content if this is a concern.19,21,22

First-generation progestins have a lower potency and half-life, which can result in breakthrough bleeding. While second-generation progestins are more potent with a longer half-life, they may have an androgen-like effect. Third-generation progestins maintain a high potency but have lower androgen-like effects.

Some third-generation formulations are even approved to treat mild to moderate acne. Finally, the only fourth-generation progestin, drospirenone, has both anti-mineralocorticoid and anti-androgenic properties and is newly available in a progestin-only pill.18,19 It has an improved bleeding profile while matching COCs in efficacy, as well as extending the missed-pill window to 12 hours for ease of use23 (Table 3).

Many of the common side effects of COCs will resolve on their own in the first few months. Thus, in the absence of severe side effects, patients should be encouraged to continue their pills for an initial 3-month interval. If these side effects continue or are particularly bothersome, Table 4 shows some options providers can use to approach them.19,24

In addition to bleeding patterns and progestin options, COCs can be monophasic or multiphasic. We recommend that most providers start with a monophasic preparation for ease of use and ability to extend to continuous use, although some data show that triphasic preparationsspecifically those with newer progestinshelp reduce acne, irregular bleeding, and menorrhagia.25

In addition to contraception, COCs have non-contraceptive benefits that can be advantageous to patients. One of these benefits is helping to improve menstruation, reduce pain, and improve blood loss. Dysmenorrhea is the most common menstrual symptom complaint, affecting up to 90% of women.26

COCs have been shown to reduce dysmenorrhea by 60%, and in those with severe dysmenorrhea even further (90%). This reduces absences for school or work, as well as a patients need for pain medication. In women who suffer from dysmenorrhea, it can be especially helpful to be on extended or continuous COC preparations to further decrease pain.19 The desogestrel-only POP has also been shown to help improve dysmenorrhea.27

Menorrhagia is less common, yet still problematic, for patients, as it can lead to iron-deficiency anemia. COCs are particularly helpful for normalizing bleeding patterns and decreasing both amount and duration of bleeding.

However, other forms of contraception, such as hormonal intrauterine devices, can have similar effectsenhancing the need for shared decision-making with a patient when deciding which hormonal method is right for her.28

Additional benefits to COCs include the ability to allow a woman to predict her bleeding episodes and skip them if desired. While older generations of POPs often caused abnormal bleeding patterns in patients, new drospirenone-only pills have a more favorable bleeding profile.23

COCs can also improve premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). A study looking at both POPs and COCs and their effect on premenstrual mood found that use of either one of these pills did not affect mood in over 71% of women. The remaining women were split as to whether their mood was improved or worsened.

Having a history of premenstrual mood changes prior to starting a POP or COC was a strong predictor of the ability to improve mood, as was onset of premenstrual mood disturbance at a younger age. However, those with a history of depression prior to pill use were twice as likely than those without a history to have mood deterioration.29

Studies have also shown that in women being treated for depression, COCs containing drospirenone can improve mood deterioration in the premenstrual period, as well as reduce both physical and behavioral symptoms of PMDD.30 Another way to reduce PMS and PMDD symptoms is with extended or continuous cycles and reduction of withdrawal bleeding.19

COCs can also be very useful to women who suffer from endometriosis. COCs have been shown to reduce pain associated with endometriosis and continuous cycles are often even more beneficial for pain reduction.

However, it is important to remember that COCs work by causing endometriotic implants to undergo atrophy and become inactive. Upon discontinuation of COCs, the implants become active again, resulting in return of pain and other symptoms.

Initiation of COCs after surgery for endometriosis can reduce recurrence rates of endometriomas, as well as the size and growth rates of those that do recur.31 For women who cannot take COCs but suffer from endometriosis, desogestrel-containing POPs have been shown to be equally effective in reducing endometriosis pain.14

Oral contraceptive pills are a widely used form of contraception and nearly all providers in all specialties will encounter patients who are taking them.

While different variations between pills can seem complicated, thereby making it hard to choose a pill, it is important to tailor the decision to each patients needs and desires. Sometimes it can take several adjustments to find the best OCP for a particular patient.

As long as the provider and patient continue to work together through shared decision-making, many women will be able to satisfactorily find a reliable form of contraception while also taking advantage of the many non-contraceptive benefits that pills offer.

__

About the Authors

DR. LODER is a clinical assistant professor at Michigan Medicine, University of Michigan, Ann Arbor.

DR. ROSEN is a clinical assistant professor at Michigan Medicine, University of Michigan, Ann Arbor.

DR. CHASE is a fourth-year medical student at the University of Michigan Medical School, Ann Arbor.

__

1. National Center for Health Statistics. National Survey of Family Growth 2015-2017. https://www.cdc.gov/nchs/nsfg/nsfg_2015_2017_puf.htm. Accessed May 10, 2020.

2. David PS, Boatwright EA, Tozer BS, et al. Hormonal contraception update. Mayo Clin Proc. 2006;81(7):949-954.

3. Trussell J. Contraceptive failure in the United States. Contraception. 2011;83(5):397-404.

4. Broome M, Fotherby K. Clinical experience with the progestogen-only pill. Contraception. 1990; 42(5):489-95.

5. Sheth A, Jain U, Sharma S, et al. A randomized, double-blind study of two combined and two progestogen-only oral contraceptives. Contraception. 1982;25(3):243-252.

6. Korver T. A double-blind study comparing the contraceptive efficacy, acceptability and safety of two progestogen-only pills containing desogestrel 75 g/day or levonorgestrel 30 g/day. Eur J Contracept Reprod Health Care. 1998;3(4):169-178.

7. Vessey MP, Lawless M, Yeates D, McPherson K. Progestogen-only oral contraception. Findings in a large prospective study with special reference to effectiveness. Br J Fam Plann. 1985;10:117-121.

8. Rivera R, Yacobson I, Grimes D. The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices. Am J Obstet Gynecol. 1999;181(5 Pt 1):1263-1269.

9. Centers for Disease Control and Prevention. Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use. https://www.cdc.gov/reproductivehealth/contraception/pdf/summary-chart-us-medical-eligibility-criteria_508tagged.pdf. Accessed May 10, 2020.

10. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(3):1-103.

11. Grossman D, Fernandez L, Hopkins K, Amastae J, Garcia SG, Potter JE. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obst Gynecol. 2008;112(3):572-578.

12. Elwyn G, Frosch D, Thomson R, et al. Shared decision making: A model for clinical practice. J Gen Intern Med. 2012;27(10):1361-1367.

13. Rosenberg MJ, Waugh MS, Meehan TE. Use and misuse of oral contraceptives: Risk indicators for poor pill taking and discontinuation. Contraception. 1995;51(5):283-288.

14. Amat L, Bulach A, Leclercq M, et al. Bnfices non contraceptifs des contraceptions. Additional Non-Contraceptive Effects of Contraception: CNGOF Contraception Guidelines. Gynecol Obstet Fertil Senol. 2018;46(12):883-888.

15. Gallo MF, Nanda K, Grimes DA, Lopez LM, Schulz KF. 20 g versus >20 g estrogen combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2013;2013(8):CD003989.

16. Golden NH. Bones and Birth Control in Adolescent Girls. J Pediatr Adolesc Gynecol. 2020;33(3):249-254.

17. Scholes D, Ichikawa L, LaCroix AZ, et al. Oral contraceptive use and bone density in adolescent and young adult women. Contraception. 2020;81(1):35-40.

18. Lawrie TA, Helmerhorst FM, Maitra NK, Kulier R, Bloemenkamp K, Glmezoglu AM. Types of progestogens in combined oral contraception: effectiveness and side-effects. Cochrane Database Syst Rev. 2011;11(5):CD004861.19. Raney EC, Scott SC, Cauthon KAB. Individualizing selection of hormonal contraception. Osteopathic Family Physician. 2014;6(4):8-14.

20. Sitruk-Ware R. Pharmacology of different progestogens: The special case of drospirenone. In Climacteric. 2005;8(Suppl 3):4-12.

21. Thorneycroft IH. Update on androgenicity. Am J Obstet Gynecol. 1999;180(2 Pt 2):288-294.

22. Stanczyk FZ. All progestins are not created equal. Steroids. 2003;68(10-13):879-890.

23. Palacios S, Regidor PA, Colli E, et al. Oestrogen-free oral contraception with a 4 micrograms drospirenone-only pill: new data and a review of the literature. Eur J Contracept Reprod Health Care. 2020;Apr 21;1-7. https://doi.org/10.1080/13625187.2020.1743828. Online ahead of print.

24. Barr NG. Managing adverse effects of hormonal contraceptives. Am Fam Physician. 2010;82(12):1499-1506.

25. Cedars MI. Triphasic oral contraceptives: Review and comparison of various regimens. Fertil Steril. 2002;77(1):1-14.

26. Jamieson DJ, Steege JF. The prevalence of dysmenorrhea, dyspareunia, pelvic pain, and irritable bowel syndrome in primary care practices. Obstet Gynecol. 1996;87(1):55-58.

27. Ahrendt HJ, Karckt U, Pichl T, Mueller T, Ernst U. The effects of an oestrogen-free, desogestrel-containing oral contraceptive in women with cyclical symptoms: Results from two studies on oestrogen-related symptoms and dysmenorrhoea. Eur JContracept Reprod Health Care. 2007;12(4):354-361.

28. Lethaby A, Wise MR, Weterings MAJ, Rodriguez MB, Brown J. Combined hormonal contraceptives for heavy menstrual bleeding. In Cochrane Database System Rev. 2019;2(2):CD000154.

29. Joffe H, Cohen LS, Harlow BL. Impact of oral contraceptive pill use on premenstrual mood: Predictors of improvement and deterioration. Am J Obstet Gynecol. 2003; 189(6):1523-1530.

30. Yonkers KA, Brown C, Pearlstein TB, Foegh M, Sampson-Landers C, Rapkin A. Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstet Gynecol. 2005;106(3):492-501.

31. Zorbas KA, Economopoulos KP, Vlahos NF. Continuous versus cyclic oral contraceptives for the treatment of endometriosis: a systematic review. In Arch Gynecol Obstet. 2015;292(1):37-43.

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Choosing the right pill - Contemporary Obgyn

Recommendation and review posted by Bethany Smith

Yep, cheese and fruit are healthy bedtime snacks.

Many of us have been taught that eating before bed is a bad idea. But what should you do if you wake up in the middle of the night with a growling stomach, or you can't fall asleep because you were already hungry before bed? Or, sometimes you're just craving a snack while binge-watching Netflix, even if you're not that hungry. Whatever the reason for snacking, some bedtime snacks are healthier than others.

"Bedtime snacks can be healthy and can help you sleep better," says Tony Castillo, a registered dietician and performance dietician at Nutrition for Performance. He says people who workout regularly and are active in particular can benefit, since you can add in nutrients that can help muscles repair and recover while you sleep.

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But there are some foods you may want to avoid eating before bed because they may disrupt your sleep. You'll want to avoid junk food that contains lots of sugar and processed carbs, since those can work against helping you get a good night's sleep. "The fast-digesting carbs could cause a boost of energy," says Castillo.

Something else you'll want to avoid before bed? Spicy foods, since those can cause acid reflux, and no one wants to wake up to digestive issues throughout the night. Another common heartburn trigger is chocolate, because it'shigh in fat and contains other ingredients that can mess with digestion at night.

Keep reading below for more bedtime nutrition tips and ideas for healthy snacks that can help you sleep better tonight.

Besides focusing on balancing nutrition with high quality foods (like the ones below) at night, you should also consider timing your snacks in a way that does not interfere with sleep. This can vary from person to person, but typically you will want to avoid eating immediately before falling asleep.

"There are some individuals that can eat something right before bed and have no issues. Others may have to have a cutoff time of two hours [before bed] because eating the food may cause acid reflux," Castillo says. It may take some trial and error, but giving yourself some room to digest before bed can help prevent problems.

Peanut butter and bananas or peanut butter on whole-grain, high-fiber toast are examples of balanced night-time snacks.

"I recommend a slow-digesting protein and high-fiber carbohydrate," Castillo says. "You want the slow-digesting protein to keep the muscle-building switch on while you sleep. You want a high-fiber carb because a fast-digesting carb can cause a blood sugar spike and keep you awake."

Slow-digesting and high fiber carbs are ones that tend to be easier on your blood sugar, helping avoid spikes or subsequent crashes. Examples of slow-digesting carbs are whole grains, oats, brown rice, fruits and veggies. Slow-digesting proteinsinclude casein, which is found in dairy, such as yogurt and cheese, and is available as a protein powder. Peanut butter is also useful to eat before bed because it contains tryptophan, which helps your brain and muscles relax.

Healthy bedtime snack examples:

Almonds contain melatonin and magnesium, which can help you sleep better.

Certain foods can promote better sleep, for reasons other than helping you feel full. Certain foods naturally contain nutrients that promote sleep like melatonin, the hormone that makes you feel sleepy.

Foods that can help you sleep:

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

See more here:
Healthy bedtime snacks that won't mess with your sleep - CNET

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Breast cancer affects one in eight women in the United States. Its one of the most common cancers in the country, but thanks to preventative screenings and developments in treatment, the disease currently has a five-year relative survival rate of 90 percent. But when you dig into the statistics a bit more, youre presented with a less optimistic outlook. According to the Centers of Disease Control and Prevention (CDC), Black and white women get breast cancer at about the same rate, but breast cancer deaths among Black women are 40 percent higher than white women. (For Asian, Hispanic, and Native American women, the risk of developing and dying from breast cancer is lower than white women.) These are the straight facts, laid out in black and white.

The reasons Black women are more likely to die from breast cancer than white women are complex, but the disparity is, in fact, surmountable. The solutions arent easy or quick, but they do exist. If this is a problem that doesnt need toand shouldntexist, why does it?

As with any cancer, early diagnosis is key to successful treatment, and the fact that white women tend to be diagnosed at an earlier stage of breast cancer than Black women exposes a major problem from the get-go. Its really a matter of the benefit of being screened in a mammogram, which is how we screen for breast cancer, says Nicola Finley, MD, an integrative physician at Canyon Ranch Tucson. Unfortunately, Black women [tend to be] diagnosed for all cancers when theyre at a more advanced stage. This leads to a higher mortality rate, because there are more obstacles and barriers in terms of treatment at a more advanced stage.

Health-care access is a huge driver of this disparity, says Jennifer Sims, PhD, an assistant professor at Jackson State Universitys School of Public Health who wrote an academic paper about health and racial disparity in breast cancer. Black women tend to have limited access to quality health care, and the reason for this is because they tend to have a lower economic status, she explains. Black women are statistically more likely to live in poverty than white women, which not only affects insurance access but also access to transportation, the ability to take time off work, and arrange child careall of which impacts a persons ability to seek care in the first place.

Thus, many Black women are forced to wait to go to the doctor until theres something visibly wrong, says Dipali Sharma, PhD, a professor of oncology at Johns Hopkins University. One of my colleagues and I were discussing this very topic the other day and she told me about a Black women who had a breast tumor that was literally coming through her skin. But she kept waiting and hoping it would just go away on its own because it was difficult for her to take off of work, Dr. Sharma says. Often, by the time Black women come to the clinic, their cancer is already stage three or four. (Research supports this observation.)

New research also suggests once a breast cancer diagnosis is given, Black women face longer delays to starting treatment and longer treatment times than white women. Even among women with low socioeconomic status, we still saw fewer delays among white women, underscoring the disparate experience of Black women, who appear to experience unique barriers, said lead author Marc Emerson, PhD, in a press release about the study. These delays could affect outcomes, since the longer cancer goes untreated, the harder it is to eliminate. More research needs to be done to understand exactly whats contributing to these delays, but the authors theorize that specific financial and transportation barriers could be at play.

Even when Black women are able to get to the doctor, Dr. Sims says they often face medical racism that impacts their care, regardless of social status. In her book, Invisible Visits: Black Middle-Class Women in the American Healthcare System, Tina Sacks, an assistant professor at UC Berkeleys School of Social Welfare, discusses the many challenges Black middle-class women face in trying to get doctors to take their concerns seriously. This can lead to them being less likely to get further medical testing and screenings when theyre needed. To her point, a Journal of Clinical Oncology study found that Black women, regardless of their risk level, are less likely than white women to undergo genetic testing for the BRCA1/2 geneaka the gene associated with breast, ovarian, and pancreatic cancerin large part because physicians are less likely to recommend it to them.

Some doctors see breast cancer as a white womans disease more than a Black womans disease, so they may not screen Black women as often. Jennifer Sims, PhD

As a Black woman, when I see a doctor, I always make sure to present myself in a particular way, says Dr. Sims. Most of the time when a doctor sees me, they see a Black woman and nothing else. I always make sure they know I did my research beforehand so they take me seriously. I tell them Im an assistant professor and have a PhD and studied at Harvard Medical School. In doing so, I tend to be treated differently than my sister, who has the exact same doctor as I do. This is an example of the type of bias most white women will never experience.

Additionally, Dr. Sims says some Black women feel judged by doctors, which affects their interest in seeking care. If someone has had a negative experience with a doctor who made them feeling shamed, judged, or discriminated against in the past, they are less likely to make check-ups and appointments a priority, she says.

Even if the playing field was level, and women of all races had the same access to unbiased health care, Black women would still be at a disadvantage when it comes to their survival. Sandra Luyindula, MD, a primary care physician at Proactive MD, says that Black women are more likely than white women to be diagnosed with triple-negative breast cancer, a subtype of the disease that is linked to a worse prognosis than other subtypes. (It makes up 10 to 15 percent of all breast cancer cases.)Triple-negative breast cancer is two to three times more common in Black women under the age of 60, she says, adding that it is also more aggressive and has a higher likelihood of recurrence than other types of breast cancer.

Sadly, Dr. Luyindula says we still dont know why this type of cancer is more common in Black women. Triple negative breast cancer is certainly being studied, but [researchers] havent figured it out yet, she says. And there arent many treatment options that work for it, either. Dr. Sharma explains that not only is triple-negative breast cancer aggressive, it doesnt respond to hormone therapy or targeted drugs.

There definitely needs to be more therapy options for women with triple-negative breast cancer, Dr. Sims says. There is a new drug that came out this year, Trodelvy, but whats interesting about that particular drug is that the clinical studies didnt actually include many Black women.This is unfathomable to her. Triple-negative breast cancer predominately affects Black women, so why arent they part of the clinical studies?

This shows that racial bias isnt limited to the doctors office; it permeates research institutes and clinical trials as well. Theres this untrue belief that Black women dont want to participate in medical studies, but the truth is, we need to make it easier for them, Dr. Sharma says. For example, at Johns Hopkins, often we give study participants a gift card as an incentive to participate in studies. But when we issued surveys, we learned something that keeps them from participating is the cost of parking, which can be $20 or $25. So something as simple as giving them a free parking sticker can make it easier for people to participate in studies.

Of course, study participants also need transportation, childcare, and the ability to take time off of work. Rather than writing off a population, we really need to ask what can be done to make participating in studies easier, and then do whats necessary to meet the needs, Dr. Sharma says.

More inclusive clinical studies will lead to better treatment outcomes for Black women diagnosed with breast cancer, but that alone is not enough. We need multilayered solutions that match the complexity of the problem.

To start, Dr. Sims says doctors and health-care providers should go through implicit bias training. Some doctors see breast cancer as a white womans disease more than a Black womans disease, so they may not screen Black women as often, even if they are showing the same symptoms as a white woman, she says. A lot of this bias is unconscious. You may think you have no bias toward Black women, or even women in general, and then you take an implicit-bias test and you see that you are biased.

Most of the time when a doctor sees me, they see a Black woman and nothing else. Dr. Jennifer Sims

Patient advocates and, in some cases, interpreters can also benefit Black women navigating a cancer diagnosis, and perhaps improve their survival chances. Dr. Luyindula says that at her practice, all patientsregardless of race or socioeconomic statusare assigned a patient advocate who ensures they have everything they need to continue treatment, including transportation. She adds that patient advocates can also help address a patients concerns about their ability to come to treatment appointments, access to healthy foods, or other health concernsall questions a doctor might not be able to fully answer during a time-pressed appointment. Meanwhile, an interpreter can help patients overcome language barriers to get the answers they need to make decisions about their carewhich can help improve outcomes, too.

More effort needs to be made for breast cancer prevention to be equitable, too. Mammogram screenings, which are the first line of defense again breast cancer, need to be more accessible to more people where theyre at. Dr. Sims says shes seen creative solutions for this problem, like volunteer organizations hosting cancer screenings at predominantly Black churches. Another solution could be free mammogram screenings at various workplaces, so it doesnt require taking time off work to be screened.

These solutions are just a start, but with time they can make a difference. There needs to be creative solutions to meet needs at an individual level because not everyone has the same needs, Dr. Luyindula says. This is a big, multifactorial issue. We need to understand every component to treat this issue as a whole.

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Black Women Arent More Likely To Get Breast Cancer, but They Are More Likely To Die From It - Well+Good

Recommendation and review posted by Bethany Smith

It was a simple study design. Retrospective and observational, in today's science, a fishing trip for correlation by computer. All the patients with a positive COVID-19 test during March through June of this year from Quest served as the population, which was refined to include only those who had a Vitamin D level drawn in the previous year. A patient's ethnicity was "inferred" from their zip code based upon the 2018 America Community Study, a government study done every five years that reports on the many demographics of our country. 88% of those with positive COVID-19 tests also had a Vitamin D test, so the study group consisted of 192,000 individuals from across the nation.

"There was an association between lower SARS-CoV-2 positivity rates and higher circulating 25(OH)D levels."

The researchers acknowledge the limitation that their population was selected based on how symptomatic they might have been; after all, the request for COVID-19 testing was prompted by some concern on the part of the patient or physician. They also note that inferring ethnicity from zip codes may be problematic. Is this a sufficient mea culpa?

Not really. There is a second selection bias left unstated and more problematic why were these individuals having Vitamin D levels determined? It is not a routine laboratory test. There are a variety of conditions that may result in a deficiency. There are several that have been noted in other settings to be COVID-19 risk factors. They include obesity and its surgical management, chronic kidney disease, immobility that would leave you housebound or in a nursing facility, a higher risk of fractures, and skin color; darker-skinned individuals are less able to produce Vitamin D given similar exposure to the sun. Other recognized causes of Vitamin D deficiency include medications used to treat HIV, epilepsy, and elevated cholesterol. I suspect because the authors do not elucidate that the population under study were those who had a suspected deficiency in Vitamin D, who coincidentally had COVID-19 tests. That changes the denominator and makes the sample size of their population much different.

There are a lot of unanswered questions about Vitamin D. We know that it is essential, but what constitutes deficiency remains a product of consensus. Values in the group that the researchers identified as deficient are in that consensus. But the use of italics in categorizing that level as a "deficiency" is the nuanced signal that the word choice itself is a bit biased. Because physicians have no hard and fast cut-off, estimates of Vitamin D deficiency in the population range from 50% to 100%. The lay press has identified many early symptoms of a possible Vitamin D deficiency, including fatigue, frequent colds, bone, muscle and back pain, hair loss, and depression. When coupled with an inexpensive, non-prescription treatment, you have the setting for screening more low risk than high-risk patients. The CDCreportsthat Vitamin D testing increased 83-fold between 2000 and 2010 among Medicare beneficiaries, an admittedly higher risk group.

This study sheds no additional light or insights. It merely adds to the growing literature that Vitamin D may or may not be involved in, whatever disease you wish to mention.

Source: SARS-CoV-2 positivity rates associated with circulating 25-hydroxyvitamin D levels PLOS DOI: 10.1371/journal.pone.0239252

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Can Vitamin D Play a Role in Treating or Preventing COVID-19? - American Council on Science and Health

Recommendation and review posted by Bethany Smith

Updated Results Demonstrate Significant DCCR Exposure Response Relationship

Interim Analysis of Open-Label Extension Data Demonstrate Continued Efficacy

Improvements in Body Composition and Metabolic Measures Support Efficacy of DCCR in Treatment of PWS Symptoms

REDWOOD CITY, Calif., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that updated top-line results from the Companys Phase III trial, DESTINY PWS (C601), evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS), were highlighted in an oral presentation by Jennifer L. Miller, M.D., Professor in the Division of Pediatric Endocrinology at the University of Florida, at the Foundation for Prader-Willi Research Annual Research Symposium.

DESTINY PWS is a randomized, double-blind, placebo-controlled Phase III study of oncedaily oral administration of DCCR in 127 PWS patients conducted at 29 sites in the U.S. and U.K. The objective of the study was to assess the efficacy and safety of DCCR in subjects ages four years and older, with genetically-confirmed PWS. Patients who completed the double-blind study enrolled in study C602, an ongoing open-label, extension study.

Soleno previously announced initial top-line results from DESTINY PWS in June 2020. The study did not meet its primary endpoint of change from baseline in hyperphagia, measured by the total score of a Hyperphagia Questionnaire for Clinical Trials (HQ-CT, 036). However, significant changes were observed in two of three key secondary endpoints, improvement in physician assessed Clinical Global Impression of Improvement score and reduction of body fat mass, in subjects receiving DCCR as compared to placebo. An interim analysis of the subset of patients who completed 13 weeks of treatment on C602 showed a continued improvement in hyperphagia, as well as several other PWS related behaviors.

Key updated results:

The results from this program continue to demonstrate DCCRs beneficial impact on hyperphagia, the predominant symptom of PWS, other behaviors typical of PWS, as well as problems related to body composition, and a safety profile that is well understood, said Dr. Miller, a Principal Investigator in the Soleno study. The sum total of data presented to date suggest that DCCR, if approved, may be a safe and effective treatment option that can address both the behavioral and metabolic components of PWS. I look forward to continued progress in advancing DCCR as the first potentially approved treatment for key unmet needs associated with PWS, a devastating condition with life-threatening comorbidities.

These compelling updated data bolster our confidence in DCCRs safety and efficacy profile in PWS, said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. We continue to treat patients in study C602, our open-label extension. As we have previously communicated, we expect to meet with the U.S. Food and Drug Administration before year-end to determine next steps and a potential path forward to address the unmet need for a safe and effective treatment option for PWS patients.

DCCR has orphan designation for the treatment of PWS in the U.S. and EU and Fast Track designation from the U.S. Food and Drug Administration.

About PWSThe Prader-Willi Syndrome Association USA estimates that one in 12,000 to 15,000 people in the U.S. have PWS. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant morbidities (e.g., stomach rupture, obesity, diabetes, cardiovascular disease) and mortality (e.g., choking, accidental death due to food seeking behavior). In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia as the most important or a very important symptom to be relieved by a new medicine. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and EU, and Fast Track Designation in the U.S.

About Diazoxide Choline Controlled-Release (DCCR) TabletDiazoxide Choline Controlled-Release tablet is a novel, proprietary extended-release, crystalline salt formulation of diazoxide, which is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and adults, but has not been approved for use in PWS. Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS. The DCCR development program is supported by data from five completed Phase I clinical studies in healthy volunteers and three completed Phase II clinical studies, one of which was in PWS patients. In the PWS Phase II study, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters.

About Soleno Therapeutics, Inc.Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The companys lead candidate, Diazoxide Choline Controlled-Release (DCCR) tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase III clinical development program. For more information, please visit http://www.soleno.life.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS and the impact of the COVID-19 pandemic on our operations and clinical trial. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions, as well as risks and uncertainties inherent in Solenos business, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578

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Soleno Therapeutics Announces Updated Top-line Results from Phase III Trial of DCCR for Treatment of Prader-Willi Syndrome - GlobeNewswire

Recommendation and review posted by Bethany Smith

Just as scientists are rapidly learning how SARS-CoV-2 affects humans, they are also quickly working to understand how it affects other animals. House cats, tigers, golden hamsters, and rhesus monkeys are all susceptible to SARS-CoV-2 infection. And while avian species such as duck and chicken are not, dogs, pigs, and ferrets have shown intermediate susceptibility.

The critical entry point for the virus into our cells is a protein called ACE2, which bonds withthe spike protein of SARS-CoV-2.Animals and humans both expressing ACE2 in their cells, so scientists have been wondering why different species have different SARS-CoV-2 susceptibility, and if it is possible to predict which animals might be at risk.

In a preprint posted on bioRxiv in July, researchers at Vanderbilt Universityapproached this question by comparing the amino acid sequence of ACE2 from different animal species. Amino acids are compounds that combine to form proteins. Inside cells, this amino acid chain folds into a three-dimensional shape. And as a result, some amino acids become hidden, and others exposed. Exposed ACE2 amino acids are of great interest because they determine whether SARS-CoV-2 can attach to the cell.

Using computer models, researchers identified amino acids in ACE2 that showed strong interactions with SARS-CoV-2. They observed that in non-susceptible animal species, these amino acids were often different, ultimately disrupting the attachment between the ACE2 protein and the spike protein of SARS-CoV-2. This allowed the researchers to make predictions about which animals species are possibly at risk of infection. They estimated that while horses and camels would be vulnerable to infection, cows, goats, and Malayan pangolins would present intermediate susceptibility.

In August, another preprint fromresearchers at Dalhousie University in Nova Scotiaexamined whether marine wildlife are susceptible to the virus. Using similar modeling methods, these researchers concluded that whales, dolphins, seals, and otters would be susceptible to SARS-CoV-2. They suggest that exposure could happen through contaminated sewage entering the sea.

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Lactose tolerance spread through Europe faster than previously thought - Massive Science

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