Archive for the ‘Genetic Testing’ Category

Mutations in the myosin 5, syntaxin-binding protein 2, and syntaxin 3 genes lead to microvillus inclusion disease (MVID), an autosomal recessive congenital enteropathy. This rare disease is characterized by lack of microvilli on the surface of enterocytes in the small intestine, the presence of pathognomonic intracellular microvillus inclusions, and vesicular bodies within these enterocytes. This pathology leads to the characteristic intractable, life-threatening, watery diarrhea. In the more common early-onset form, affected patients present in the first few days after birth, whereas in the late-onset form, clinical manifestations appear at approximately 2 to 3 months of age. Genetic testing can confirm the diagnosis, but the infants medical history, clinical presentation, and small intestinal biopsy results are strongly suggestive of the diagnosis. The prevalence of MVID is thought to be higher in countries with a high degree of consanguinity. Patients with MVID cannot tolerate feedings and require continuous total parenteral nutrition. Mortality is extremely high in the early-onset type with reports of survival in patients treated with small intestinal transplantation. Medical counseling for parents of infants with MVID needs to reflect our current understanding of the various genetic forms of this disease, the feasible management, and anticipated outcomes.

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Challenges of Microvillus Inclusion Disease in the NICU - AAP News

SAN CARLOS, Calif., Sept. 1, 2020 /PRNewswire/ -- Natera, Inc.(NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced the publication of a prospective, randomized controlled trial showing clinical utility of the Prospera test. The study concluded that practicing nephrologists who used the Prospera test detected more cases of rejection and made better clinical decisions than physicians in the control group. The study evaluated kidney transplant patients in typical scenarios seen by nephrologists in routine practice. The study was published in International Urology and Nephrology,1and is available to read here.

"The Prospera test can be a vital tool in early detection and the treatment decision-making process of our patients," saidJessica Coleman, MD, Nephrologist at Beaufort Memorial Hospital. "When we evaluate patient scenarios with the Prospera test, we gain insights to help increase the chances of a successful transplant and improved outcomes."

The Prospera test's previously published clinical validation showed excellent performance in the detection of active kidney transplant rejection.2 This latest study measured the clinical practice of 154 nephrologists with and without dd-cfDNA testing. To determine whether the use of the Prospera test demonstrated overall clinical utility, 924 simulations were completed. The study, conducted by QURE Healthcare and researchers from a top academic institution, showed that those using the Prospera test to evaluate post-transplant patients were more likely to reach an early, accurate diagnosis and appropriately change their treatment compared to those using creatinine and other routine biomarkers alone.

Highlights of the study concluded:

"The results of this study provide valuable insights into the Prospera test's capabilities and utility in the nephrology practice," said Paul Billings, MD, PhD, Natera's Chief Medical Officer and a co-author on the study."Results clearly show that the use of the Prospera test demonstrated clinical utility and improved care of the emulated patients through changes in diagnosis, workup, and management after kidney transplant."

About the Prospera dd-cfDNA Organ Transplant Test

The Prosperatest leverages Natera's core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. The Prospera test has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The Prospera test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Natera

Naterais a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at http://www.natera.com/investorsand http://www.sec.gov.

ContactsInvestor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., [emailprotected]

References

SOURCE Natera, Inc.

http://www.natera.com

Excerpt from:
Study Shows Clinical Utility of the Prospera Test in Nephrology Practice - PRNewswire

A scientific search for its ancestral tree has led directly back to Vancouvers Old Apple Tree. In recent years, genetic testing has become a popular tool because people seek scientific clues about their ancestors. Vancouver Urban Forestry and the National Park Service were looking for much of the same type of information when they and a volunteer teamed up with Washington State University to answer the question: exactly what type of apple tree is the Old Apple Tree?

As it turns out, the tree is a genetically unique one-of-a-kind.

Since the Old Apple Tree was planted in 1826, the type of apple it produces has been unknown. Most often it has been referred to as an English Greening Apple which is a generic term used for a European old-world apple.

In later 2019, Paul Stasz, a volunteer with Vancouver Urban Forestry and the National Parks Service, contacted researchers at WSU-Pullman to see if the Old Apple Tree could be a part of the universitys Apple Genome Project. DNA tissue samples were carefully collected and sent to WSUs Cameron Peace, a principal investigator sequencing the worldwide family tree of apple trees. With its large database, the project can identify ancestors of specific apples.

The results from the project are now in and the genetic testing confirmed that the Old Apple Tree is not identical to any other known apple tree and has no known parent-child relationships in the extensive database. The closest relationship appears to be a distant one to the 500-year-old variety, French Reinette. French Reinette is a close direct ancestor of most modern varieties and also a parent or grandparent to many heirloom varieties.

Planted from a seed at the historical Fort Vancouver, the Old Apple Tree is considered the start of the apple industry in Washington State. Its death earlier this summer at the age of 194, was precipitated by a spiral crack in its trunk.

However, thanks to its unique genetics, the Old Apple Tree lives on. Vancouver Urban Forestry and the National Parks Service have been planning for the inevitable by nurturing several root suckers, which are now small saplings growing around the Old Apple Tree. One sapling near the center of the original tree will be cultivated and will inherit the title of Old Apple Tree, given its genetic makeup. Its the same root system, but with a new stem. The remaining saplings will be transplanted to the National Park Service's historic orchard at the Fort Vancouver National Historic Site.

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In search for ancestry, science finds old apple tree is one-of-a-kind - The Reflector

SIOUX CITY (KTIV) -- September is Ovarian Cancer Awareness month. According to the American Cancer Society, nearly 22,000 women in the United States will be diagnosed with it this year.

Ovarian cancer often goes undetected until it has spread to the abdomen or pelvis, with 75-80% being stage three or four.

About 1 in 78 women will develop ovarian cancer in their lifetime and while it's most common in women 60 and above, younger women can also develop it.

Dr. Donald Wender said there are several types of ovarian cancer.

"But by far the vast majority are either adeno or serous cancer that starts in the ovaries, commonly spreads to the uterus and within the abdomen," said Donald Wender, June E Nylen Cancer Center Head of Medical Oncology.

So what you should be looking for? Unfortunately, Dr. Wender said the symptoms are like a lot of things.

"Bloating, abdominal distension, maybe frequent urination which by far more likely is a UTI than this," said Dr. Wender. "Sometimes shortness of breath, weight loss, or weight gain. They're very vague symptoms and the problem is these symptoms are usually there when you already have a fairly advanced ovarian cancer."

Since the symptoms are often hard to recognize, Dr. Wender said early detection is key. That can include routine pelvic exams and looking at family history. How often you get that, depends on your risk factor.

"Women who have a history, family history of ovarian cancer, women who have a family history of breast cancer, may have a higher risk," said Dr. Wender. "Then there can be some genetic testing that can be done."

Dr. Wender said some women at high risk choose to take out their ovaries, but even if you do that, he said you can still develop cancer similar to ovarian. He said the process to surgically remove cancer, is extensive.

"Taking out the ovaries, the uterus, sampling lymph nodes, looking at the diaphragm," said Dr. Wender. "Sometimes they sample a diaphragm. They'd sample little spots because ovarian cancer tends to form little implants within the abdomen. They'll take those out."

So how does he prepare those patients?

"Get to the surgery, get the chemotherapy done," said Wender. "Then I do tell them there is a high rate of it coming back, but not everyone's comes back and there are things to do."

Dr. Wender said if you are experiencing symptoms, you should contact your primary care physician or gynecologist.

Dr. Wender said the survival rate for stage one, is very high. Stage two moves to around 80%. But oftentimes that survival rate drops to 5 years in the later stages.

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HEALTHBEAT 4: Treating and preventing Ovarian Cancer - KTIV

The study on the Genealogy Products and Services Market Research offers a profound comprehension of the market dynamics like opportunities, drivers, trends, and the challenges. The analysis further elaborates on the micro and macro-economic aspects which can be predicted to shape the rise of the Genealogy Products and Services Market throughout the forecast period (2019-2029).

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Genealogy Products and Services Market Segmentation Assessment

The development prospects of this Genealogy Products and Services Marketplace in various Regions are analyzed in the report together with information such as political, the regulatory frame, and economic outlook of each region.

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Demand for Genetic Testing to Surge as Preventive Healthcare and Pharmacogenomics Gain Traction

Preventive healthcare is gradually gaining center stage with consumers becoming increasingly aware of the benefits of the practice. Genetic testing plays a vital role in preventive healthcare as it provides a potential technique for diagnosis of rare diseases. It is showing promising prospects for precisely predicting the risk of developing a particular disease by studying the complex genetic markup of the population.

Numerous researchers claiming the efficacy of genetic testing are promoting its adoption. The procedure can potentially enable doctors to suggest measures to prevent the development of a certain health condition. Investments by governments are further fueling the growth of the genealogy products & services market. For instance, the National Health Service in England recently announced its plan to expand genetic testing capabilities to improve the quality of health services in the country.

Development of pharmacogenomics is another factor imperative to genealogy products & services market growth. Pharmacogenomics is the study of genetics to predict the impact of medication on the human body. Genetic testing is already being leveraged for prescribing personalized medications in the treatment of panic disorder, anxiety, schizophrenia, bipolar disorder, and post-traumatic disorder.

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Genealogy Service Providers Widening the Scope of Application

Genealogy products & services providers are foraying into an assortment of different verticals to extend their consumer base. Use of genealogy and genetic testing for offering personalized services in a multitude of markets is gradually gaining traction. Companies such as EpigenCare and SkinGenie are leveraging genetic testing to provide skin care products that particularly complement the genetic makeup of a persons skin. On the other hand, Pheramor, a company based in Houston, is using genetic testing for finding people their compatible partners. Another example of the widening scope of genealogy products & services is Vinome, a company which provides a thorough report of the different wines a person may have an affinity for after studying their genetic makeup.

Aggressive marketing techniques, coupled with growing consumer inquisitiveness about such implications of genealogy, is aiding these applications in gaining popularity which, in turn, is expected to bolster genealogy products & services market growth.

Technological Innovations Complementing Market Growth

Genealogy products & services market is estimated to benefit from headways in technology. Genealogy products & services companies are harnessing data analytics, machine learning, big data, and artificial intelligence for effectively storing and analyzing a large amount of data. Genealogy products and services companies are increasingly using online platforms for marketing their services and increaing penetration into the market.

Enhanced DNA sequencing technology is further helping companies in analyzing genetic sequences at a faster rate and affordable costs while providing them accurate results. For instance, scientists in Estonia were successfully able to develop a genetic testing technology which analyzes genes at single-molecule level, paving way for enhancing the efficacy of precision medicines at lower costs. Other factors such as the development of sophisticated infrastructure for efficient sharing of huge DNA datasets is estimated to bolster genealogy products & services market growth.

Data Confidentiality Continues to Pose Challenges

The current status-quo in the genealogy products andservices market involves digital storage of data exposing it to the dangers of cybercrime and hacking. Additionally, genetic testing also influences life insurance premiums with companies considering results from the process to determine premiums. Insurance companies in Australia include genetic tests results in the risk classification for underwriting and are allowed to deny insurances in case the results predict the development of life-threatening diseases in the future. Further, the procedure can potentially cause discrimination during employment with the employers denying applications on the possibility of an applicant developing a disability in the future. Although the law prohibits companies from doing so, illegal leaking of information can influence the process.

While registering for genealogy processes, consumers compulsorily need to provide valuable information such as credit card numbers, name, and email addresses. This makes the companies a favorite target of cybercriminals. In addition to this, the increasing instances of data breaches are estimated to discourage consumers from using the services. Presence of lax or no regulations for classifying genetic testing as effective is adding to consumers confusion and poses a vital challenge to the genealogy products & services market growth.

Definition

Genealogy is the study of heritages and lineages, and comprises lineage tracing, DNA testing, cemetery records, family tree creation, and other related services.

About the Report

The report on genealogy products and services market provides an all-inclusive assessment of all the factors influencing the genealogy products & services market. Additionally, the report on genealogy products & services market provides a qualitative and quantitative assessment of each of the factors identified. The report also includes an opportunity assessment of the genealogy products & services market. An assessment of the competitive landscape prevalent in the genealogy products & services market has also been included in the report.

Market Structure

The report on genealogy products andservices market segments the genealogy products & services market on the basis of category and region. Based on the category, the genealogy products & services market can be segmented into family records, family tree, forum, cemetery, newspapers, blogs, links, and DNA testing.

Additional Questions Answered

In addition to the aforementioned insights about the genealogy products & services market, the report answers the following vital questions about the genealogy products andservices market:

Research Methodology

The report on genealogy products & services market is a consequence of robust and exhaustive research methodology. A two-step research process was employed to obtain insights into the genealogy products andservices market. Interviewing experts from the genealogy products & services market formed the basis of primary research while secondary research was conducted by thoroughly studying genealogy products & services trade journals, paid sources, and other industry-related publications. Results from both the steps were triangulated to produce an accurate forecast of the genealogy products andservices market.

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Genealogy Products and Services Market: Recent Industry Trends and Projected Industry Growth, 2018 to 2024 - The News Brok

The research study presented in this report offers complete and intelligent analysis of the competition, segmentation, dynamics, and geographical advancement of the Global Direct-Access Genetic Testing Market. The research study has been prepared with the use of in-depth qualitative and quantitative analyses of the global Direct-Access Genetic Testing market. We have also provided absolute dollar opportunity and other types of market analysis on the global Direct-Access Genetic Testing market.

It takes into account the CAGR, value, volume, revenue, production, consumption, sales, manufacturing cost, prices, and other key factors related to the global Direct-Access Genetic Testing market. All findings and data on the global Direct-Access Genetic Testing market provided in the report are calculated, gathered, and verified using advanced and reliable primary and secondary research sources. The regional analysis offered in the report will help you to identify key opportunities of the global Direct-Access Genetic Testing market available in different regions and countries.

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The authors of the report have segmented the global Direct-Access Genetic Testing market as per product, application, and region. Segments of the global Direct-Access Genetic Testing market are analyzed on the basis of market share, production, consumption, revenue, CAGR, market size, and more factors. The analysts have profiled leading players of the global Direct-Access Genetic Testing market, keeping in view their recent developments, market share, sales, revenue, areas covered, product portfolios, and other aspects.

The key players covered in this study23andMeMyHeritageLabCorpMyriad GeneticsAncestry.comQuest DiagnosticsGene By GeneDNA Diagnostics CenterInvitaeIntelliGeneticsAmbry GeneticsLiving DNAEasyDNAPathway GenomicsCentrillion TechnologyXcodeColor GenomicsAnglia DNA ServicesAfrican AncestryCanadian DNA ServicesDNA Family CheckAlpha BiolaboratoriesTest Me DNA23 MofangGenetic HealthDNA Services of AmericaShuwen Health SciencesMapmygenomeFull Genomes

Market segment by Type, the product can be split intoDiagnostic ScreeningPGDRelationship testingMarket segment by Application, split intoOnlineOffline

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

The study objectives of this report are:To analyze global Direct-Access Genetic Testing status, future forecast, growth opportunity, key market and key players.To present the Direct-Access Genetic Testing development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by type, market and key regions.

In this study, the years considered to estimate the market size of Direct-Access Genetic Testing are as follows:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year 2020 to 2026For the data information by region, company, type and application, 2019 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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Direct-Access Genetic Testing Market Size and Forecast

In terms of region, this research report covers almost all the major regions across the globe such as North America, Europe, South America, the Middle East, and Africa and the Asia Pacific. Europe and North America regions are anticipated to show an upward growth in the years to come. While Direct-Access Genetic Testing Market in Asia Pacific regions is likely to show remarkable growth during the forecasted period. Cutting edge technology and innovations are the most important traits of the North America region and thats the reason most of the time the US dominates the global markets. Direct-Access Genetic Testing Market in South, America region is also expected to grow in near future.

The Direct-Access Genetic Testing Market report highlights is as follows:

This Direct-Access Genetic Testing market report provides complete market overview which offers the competitive market scenario among major players of the industry, proper understanding of the growth opportunities, and advanced business strategies used by the market in the current and forecast period.

This Direct-Access Genetic Testing Market report will help a business or an individual to take appropriate business decision and sound actions to be taken after understanding the growth restraining factors, market risks, market situation, market estimation of the competitors.

The expected Direct-Access Genetic Testing Market growth and development status can be understood in a better way through this five-year forecast information presented in this report

This Direct-Access Genetic Testing Market research report aids as a broad guideline which provides in-depth insights and detailed analysis of several trade verticals.

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Direct-Access Genetic Testing Market Extensive Growth Opportunities to Be Witnessed by 2019-2026 - The Scarlet

A detailed research study on the Direct-to-Consumer Genetic Testing (DTC-GT) Market was recently published by DataIntelo. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. The report puts together a concise analysis of the growth factors influencing the current business scenario across various regions. Significant information pertaining to the industry analysis size, share, application, and statistics are summed in the report in order to present an ensemble prediction. Additionally, this report encompasses an accurate competitive analysis of major market players and their strategies during the projection timeline.

The latest report on the Direct-to-Consumer Genetic Testing (DTC-GT) Market consists of an analysis of this industry and its segments. As per the report, the market is estimated to gain significant returns and register substantial y-o-y growth during the forecast period.

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According to the report, the study offers details regarding the valuable estimations of the market such as market size, sales capacity, and profit projections. The report documents factors such as drivers, restraints, and opportunities that impacts the remuneration of this market.

An Outline of the Major Key Points of the Direct-to-Consumer Genetic Testing (DTC-GT) Market Report:

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The Geographical Landscape of the Market Include:

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Some of the Major Highlights of TOC Covers:Chapter 1: Executive Summary

Chapter 2: Methodology & Scope

Chapter 3: Market Insights

Chapter 4: Company Profiles

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About DataIntelo:DATAINTELO has set its benchmark in the market research industry by providing syndicated and customized research report to the clients. The database of the company is updated on a daily basis to prompt the clients with the latest trends and in-depth analysis of the industry. Our pool of database contains various industry verticals that include: IT & Telecom, Food Beverage, Automotive, Healthcare, Chemicals and Energy, Consumer foods, Food and beverages, and many more. Each and every report goes through the proper research methodology, validated from the professionals and analysts to ensure the eminent quality reports.

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Global Direct-to-Consumer Genetic Testing (DTC-GT) Industry 2020 Market Research With Size, Growth, Manufacturers, Segments And 2026 Forecasts...

The tech industry has been attempting to help test, track, treat, and terminate COVID-19 since the beginning of the pandemic.

From gritty hackathon participants to innovate startups and multi-billion dollar corporations, the industry has come together with varying results, but always with full passion.

Nex.D is one such organization. To external visitors, Nex.D might look like a traditional VC, with a website full of portfolio companies. But its model is quite different.

Nex.D uses a merchant banking advisory model, which attempts to align a founders interests with its own via equity warrants, retainers, and business development fees. Think of it as an accelerator.

Globally we are looking for the best companies we can find, founder at Nex.D, Colin Brown, told me. Ideally we find companies that are hitting $10m annual recurring revenue (ARR) and are focused on getting to $100m ARR within 2-3 years. We work with companies in the US, UK, Europe, Israel, India, and Singapore to help them accelerate.

Headquartered in Poland, its focus is on deep tech in various fields.

Here in Poland we are focused on companies at an earlier stage revenue wise but have deep global potential, Brown said. These tend to come in a number of verticals biotech, AI and data lakes, and gaming: this part of the world excels in this.

Most recently, Nex.D spearheaded an effort to reopen Europe through collaboration with genetic testing company GeneMe. GeneMe has developed FRANKD, a 30-minute, on-site COVID-19 testing solution.

The FRANKD test is currently being used by the cast, musicians, crew, and theater staff of Sleepless, a Musical Romance, which began a socially distanced indoor performances at the Troubadour Wembley Park Theater in the United Kingdom. FRANKD is also being used at the Polish resort of Zawiaty, where its test is being administered to both workers and visitors.

And Londons Heathrow Airport has just completed a successful trial of the FRANKD test as it looks to ensure passenger, staff, and UK citizen safety.

So why FRANKD, and what makes it different to other COVID-19 tests?

When we started looking at COVID-19 tests we learned very quickly that you have to read the small print, Brown said. Everyone makes the case for sensitivity at A and specificity at B, time for the test at C and limit of detection at D. But when you read the small print on their websites (and some of it isnt that small at all) you realize that all tests are certainly not equal. For example, most of them advertise a limit of detection (LOD) which sounds fantastic until you realize its a statistical limit, not a scientific one.

What does that mean in practice?

The LOD only applies when you are talking about symptomatic patients who are tested between 7-14 days after contracting the virus, tested on a Tuesday and when they were wearing a blue shoe on their left foot, Brown said. We came across a 90-minute test the other day that got a huge amount of press and it was actually 90 minutes only if you processed one sample and it was negative, but actually 7 hours if you processed more than one sample and one of them was positive.

Clearly, that level of variation isnt going to work when youre attempting to test the masses.

FRANKD is different, Brown said. We neutralize the virus in our buffer so that the testing can actually happen nearer the customer, saving time. We also use a software overlay so the results are binary (you either have COVID-19 or you dont). We also use a completely different reagent mix so we arent bidding for the same chemicals as everyone else and therefore suffering the same price escalations. Last but not least the test processing time is always 30 minutes and we are working hard to automate the sample collection.

FRANKD certainly sounds like a promising solution to the issue of mass testing at speed, and Nex.Ds intention is to accelerate its growth and scale. How? While some accelerators have a cookie cutter approach to scaling startups, Brown believes it isnt that simple.

Clearly there are some common factors but we take an individual approach to support the teams, Brown said. We both have a background in coaching teams, market entry in 50+ countries, and were working remotely in fast-paced environments. We try to pick companies that dont need restructuring, already have product-market fit, have got a super talented winning team on board and now just need to clone themselves to make the jump from $10m to $100m ARR. We help with that cloning and bring the right deals to the companies so they can execute, execute, execute, and arent wasting their time searching for the right growth opportunities.

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Meet the organization helping to scale a promising COVID-19 test solution across Europe - Grit Daily

In this report, the global 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 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 Genetic Testing market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Genetic Testing market to assist our clients arrive at beneficial business decisions.

The 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 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 Genetic Testing market report include:

Some of the major companies dealing in genetic testing market are Abbott Laboratories, BioRad Laboratories, Abbott Molecular Inc., AutoGenomics Inc., Celera Group, PerkinElmer Inc., Quest Diagnostics Inc., ELITech Group, Roche Diagnostics Corp., Applied Biosystems Inc., Roche Molecular Diagnostics Inc., Transgenomic Inc. and others.

Key points covered in the report

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

The study objectives of Genetic Testing Market Report are:

To analyze and research the 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 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 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 Genetic Testing market.

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Genetic Testing Market Is Evenly Poised To Reach A Market Value Of US$ XX Mn/Bn By - The Scarlet

Germline genetic testing is a key component of prostate cancer treatment, and broader testing criteria combined with reduced barriers to these tests could result in better informed care, including preventive surveillance, according to data from a recent study.1

Results from the retrospective study done in a total of 986 patients with prostate cancer who participated in a sponsored testing program showed that 16% (n = 153) of patients who underwent genetic testing had positive germline result; of these patients, 14% (n = 138) had pathogenic (P)/likely pathogenic (LP) variants and 1.5% (n = 15) had increased risk alleles (IRAs). Moreover, these patients were found to have 167 P/LP variants in 31 genes, as well as 19 IRAs in APC and HOXB13.

A total of 129 patients with P/LP variants had staging data available. This information indicated that 70 patients had very high-risk disease (stage III/IV), 23 had high-risk disease (stage III), and 36 had intermediate- to low-risk disease (stage IIa, IIb, and IIc). Among patients who had P/LP variants or risk alleles, only 36% reported having a family history of prostate, breast, ovarian, or pancreatic cancer.

Our initial findings from this study of [patients with] prostate cancer found an overall positive rate of 16% with 75% of positive patients being eligible for implementation of gene-specific management guidelines, precision therapies and/or clinical treatment trials, the study authors wrote. Of patients with P/LP variants, 64% did not have a close family history of prostate, breast, ovarian, or pancreatic cancer, and therefore would not have been eligible for testing based on National Comprehensive Cancer Network (NCCN) criteria.

Current criteria for germline testing in patients who have been diagnosed with prostate cancer may present a barrier to some individuals, especially those who dont have specific features regarding personal or family history, according to the investigators. Previous data have suggested that these testing criteria can exclude patients who actually harbor germline variants, which could potentially lead to suboptimal care.2

To address this, investigators launched a sponsored testing program aimed at increasing access to germline genetic testing for patients with prostate cancer through the utilization of broader criteria and eliminating cost barriers.

The program launched in July 2019 and continued throughout October 2019. Each patient enrolled on the program underwent testing that included an 84-gene, multicancer germline panel. Positive results included P and LP variants as well as IRAs. Of the 986 patients enrolled, the majority, or 70% (n = 692), were Caucasian, 13% were African American (n = 127), 3% were Hispanic (n = 33), 1.7% were Ashkenazi Jewish (n = 17), 1.0% were Asian (n = 10), and the remaining 11% (n = 107) were of unreported, mixed, or other ethnicity.

Additional results showed that when investigators evaluated diagnostic yield by disease stage, the very high-risk subgroup had a positive rate of 16%, the high-risk subgroup had a positive rate of 17%, and the intermediate- to low-risk subgroup had a positive rate of 14%.

Overall, no association of statistical significance was observed between disease stage and germline positive rate. The intermediate-/low-risk patients, who would not be indicated for germline testing based on current guidelines, had a positive rate of 14% (including P/LP variants and IRAs), the study authors wrote. Of the 36 intermediate-/low-risk patients with positive variants, 27(75%) had variants in clinically actionable genes.

Notably, 71% of patients who tested positive had P/LP variants that confers eligibility for gene-specific targeted agents or clinical trials based on variants in homologous repair or mismatch repair genes, the authors added.

These data imply that broader testing criteria could help to better inform care for many patients who might otherwise be overlooked for testing, according to the authors. By reducing barriers to testing, the authors conclude that more patients with prostate cancer would have access to crucial actionable genetic information that could lead to more targeted treatment approaches that could potentially improve outcomes.

New Recommendations Call for Increased Access to Germline Testing

The 2019 Philadelphia Prostate Cancer Consensus Conference, which brought together healthcare experts, stakeholders, and leaders from national organizations, was held to address challenges with germline testing in clinical practice and to map out a framework to increase accessibility to testing in the precision medicine era.

To do this, the panel set 3 goals: to define optimal germline testing approaches that comprise expanded panel testing options and evolving genetic data, to determine consistent germline testing indications and management, and to establish alternative genetic evaluation models in order to compensate for the shortage of genetic counseling services.3

A total of 97 participants attended the conference; these included experts in urology, medical oncology, radiation oncology, clinical genetics, and genetic counseling spaces, among others. In total, 76 participants were included on the final voting panel.

Panel members conducted a literature review with thematic topics that focused on prostate cancer risk, germline mutations by clinical and molecular characteristics of the disease, clinical multigene testing data, germline mutations in diverse populations, genetic testing capabilities and considerations, genetic counseling implementation, NCCN genetic testing guidelines, genetic testing for precision medicine in the metastatic setting, germline implications for active surveillance of early-stage disease, and germline implications for early disease detection.

Large germline panels and somatic testing were recommended for metastatic prostate cancer. Reflex testing to examine priority genes followed by expanded testing was recommended for several scenarios. Investigators determined these priority genes to be BRCA1/2 and mismatch repair genes with regard to metastatic disease treatment, and ATM in broader testing to help determine clinical trial eligibility. Additionally, BRCA2 was suggested for active surveillance discussions.

Upon completion of their review, the panel established criteria for germline prostate cancer genetic testing. Men with metastatic disease, including those with castration-resistant or castration-sensitive prostate cancer, meet the criteria for testing. In order for patients with nonmetastatic disease to be considered for genetic testing, they must either be of Ashkenazi Jewish ancestry, have advanced disease, have intraductal or ductal pathology, or be grade group 4 (Gleason sum 8) or above. Patients who have a brother or father, or 2 or more male relatives, who received a prostate cancer diagnosis and were under 60 years of age, who died from prostate cancer, or who had metastatic disease should also be considered for testing.

For those with metastatic disease, priority germline testing was recommended for those with BRCA1/2, DNA MMR genes, and further gene testing based on family history. Somatic next-generation sequencing was recommended for all men with metastatic disease. Additionally, confirmatory germline testing for somatic mutations was recommended for those with BRCA2 genes.

Reflex testing may be optimal for patients with nonmetastatic disease, according to the panel. with a recommendation to test for BRCA2 variants. For patients without a prostate cancer diagnosis but with an applicable family history, priority genes for risk assessment include BRCA2 and HOXB13.

References:

Read more:
Increased Access to Germline Testing Needed in Prostate Cancer - OncLive

Amy Edgar, APRN, CRNP, FNP-C, is an inspiring nurse practitioner seeking to change healthcare from the inside and embrace the superpowers of our next generation of humans. Weaving the threads of mom, entrepreneur, teacher, nurse, primary care provider, and science geek, she founded the Children's Integrated Center for Success in 2014. Ignited by her experience raising her now 16-year old daughter, Amy unites systems thinking and integrated care delivery models to create a primary care center focused on children with behavioral health needs. From the latest in genetics research, to nutrition, to occupational therapy and speech, to art and equine therapy, to staffing school advocates and marriage counselors -- CICS strives to have the answers their families need to reach every child, every time. In 2017, Amy led CICS to better connect career opportunities for children with autism looking for suitable work to capture their own piece of the American Dream, which has pioneered the CICS Foundation and Maker Lab.

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How Genetic Testing Will Transform Mental Health Care - Fox 4

This article is thefirst of a three-part conversation onBRCA1 and BRCA2 gene mutations.

Mutations in the BRCA1 and BRCA2 genes are linked to the development of breast cancer, ovarian cancer and other types of cancer.

Genetic testing and counseling services can determine whether a person carries these mutations and, if they do, how the information could help inform cancer prevention or treatment decisions.

In the first of a three-part conversation, Kara Milliron, a genetic counselor at the University of Michigan Rogel Cancer Center's Breast and Ovarian Cancer Risk Evaluation Clinic, discusses some of the ins and outs of BRCA gene mutations.

Both the BRCA1 and BRCA2 genes, which we all carry, play a role in making sure cells grow at the proper rate.

They act like a brake on a car, Milliron explains. When there is a change or a mutation in BRCA1 or BRCA2, those genes don't work properly, and that's where we see an increased risk for developing cancer.

These mutations can be passed down in families. Inherited susceptibility, which includes BRCA1 and BRCA2, are responsible for about 5% to 10% of breast cancers and 20% of ovarian cancers.

Thats why its important to know your family history, she says. We encourage people to try to go back three generations back to your grandparents.

Genetic counselors are on the lookout for clues in family histories that may indicate an increased risk of carrying a mutation in a cancer susceptibility gene, such as cancers that occur before the age of 50, or the occurrence of more rare cancers, such as ovarian cancer, fallopian tube cancer, primarily peritoneal carcinomatosis, pancreas cancer and male breast cancer.

When we see breast and ovarian cancer in the same individual, or when we see a rare type of melanoma called ocular melanoma, that makes us a little bit concerned about an inherited susceptibility, Milliron says. So, there are some clues that we see in the family history that make us a little bit more suspicious that there may be a gene change that's being passed on in the family.

While BRCA1 and BRCA2 mutations are most frequently talked about in relation to breast and ovarian cancers, its important to know that theyve been linked to other types of cancer as well, Milliron stresses.

Men in particular are somewhat forgotten with regards to these two genes because the cancer risks or the cancer burden is lower in men but it does have significant consequences, if a man does carry a BRCA1 or BRCA2 gene mutation, she says. They have a higher risk for developing prostate cancer and those prostate cancers tend to be more aggressive.

Genetic testing is recommended where theres a family history of aggressive prostate cancers with a Gleason score of seven or higher. And for men diagnosed with one of these aggressive prostate cancers or with metastatic prostate cancer.

Continue reading here:
BRCA1 and BRCA2 Gene Mutations: The Basics - University of Michigan Health System News

The globalNewborn and Prenatal Genetic Testing Marketis carefully researched in the report while largely concentrating on top players and their business tactics, geographical expansion, market segments, competitive landscape, manufacturing, and pricing and cost structures. Each section of the research study is specially prepared to explore key aspects of the global Newborn and Prenatal Genetic Testing market. For instance, the market dynamics section digs deep into the drivers, restraints, trends, and opportunities of the global Newborn and Prenatal Genetic Testing market. With qualitative and quantitative analysis, we help you with thorough and comprehensive research on the global Newborn and Prenatal Genetic Testing market. We have also focused on SWOT, PESTLE, and Porters Five Forces analyses of the global Newborn and Prenatal Genetic Testing market.

Leading players of the global Newborn and Prenatal Genetic Testing market are analyzed taking into account their market share, recent developments, new product launches, partnerships, mergers or acquisitions, and markets served. We also provide an exhaustive analysis of their product portfolios to explore the products and applications they concentrate on when operating in the global Newborn and Prenatal Genetic Testing market. Furthermore, the report offers two separate market forecasts one for the production side and another for the consumption side of the global Newborn and Prenatal Genetic Testing market. It also provides useful recommendations for new as well as established players of the global Newborn and Prenatal Genetic Testing market.

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Major Players:

Perkin ElmerAriosa DiagnosticsAgilent Technologies, Inc.Verinata HealthIllumina, Inc.Sequenom, Inc.CapitalBio MedLabNatera, Inc.Bio-Rad Laboratories, Inc.BGI

Segmentation by Product:

PCRFISHaCGHNIPTMSS

Segmentation by Application:

HospitalClinicOthers

Regions and Countries:U.S, Canada, France, Germany, UK, Italy, Rest of Europe, India, China, Japan, Singapore, South Korea, Australia, Rest of APAC, Brazil, Mexico, Argentina, Rest of LATAM, Saudi Arabia, South Africa, UAE.

Report Objectives

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Table of Contents

Report Overview:It includes major players of the global Newborn and Prenatal Genetic Testing market covered in the research study, research scope, and Market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the global Newborn and Prenatal Genetic Testing market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the global Newborn and Prenatal Genetic Testing market are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the global Newborn and Prenatal Genetic Testing market by application, it gives a study on the consumption in the global Newborn and Prenatal Genetic Testing market by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the global Newborn and Prenatal Genetic Testing market are profiled in this section. The analysts have provided information about their recent developments in the global Newborn and Prenatal Genetic Testing market, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the global Newborn and Prenatal Genetic Testing market as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the global Newborn and Prenatal Genetic Testing market as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the global Newborn and Prenatal Genetic Testing market.

Key Findings:This section gives a quick look at important findings of the research study.

About us:

Our research base consists of a wide spectrum of premium market research reports. Apart from comprehensive syndicated research reports, our in-house team of research analysts leverages excellent research capabilities to deliver highly customized tailor-made reports. The market entry strategies presented in our reports has helped organizations of all sizes to generate profits by making timely business decisions. The research information including market size, sales, revenue, and competitive analysis offered, is the product of our excellence in the market research domain.

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Impact of Corona on Newborn and Prenatal Genetic Testing Market : What will prove favorable for Newborn and Prenatal Genetic Testing Market? - The...

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Direct-to-Consumer Genetic Testing market.

Trusted Business Insights presents an updated and Latest Study on Direct-to-Consumer Genetic Testing Market 2019-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Direct-to-Consumer Genetic Testing market during the forecast period (2019-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

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Abstract, Snapshot, Market Analysis & Market Definition: Direct-to-Consumer Genetic Testing MarketIndustry / Sector Trends

Direct-to-Consumer Genetic Testing Market size was valued at USD 831.5 million in 2018 and is expected to witness 15.2% CAGR from 2019 to 2025.

U.S. DTC Genetic Testing Market Size, By Test Type, 2018 & 2025 (USD Million)

Rising prevalence of genetic diseases such as cystic fibrosis and Alzheimers globally is one of the major factors fostering direct-to-consumer genetic testing market growth. According to Global Genes, over 300 million people globally suffer from rare diseases. Recently developed DTC genetic tests allows consumer to identify probability of acquiring a specific genetic disease. Therefore, increasing adoption of DTC genetic testing for early disease detection and identification of genetic diseases will boost the industry growth over forecast timeline.

Increasing demand for personalized medications to treat genetic diseases will positively impact industry growth in forthcoming years. Individuals genome must be tested to develop personalized medicines. This increases the demand for DTC genetic kits since, it provides detailed information about individuals genetic predisposition. As detailed information regarding genetic makeup of individuals is easily available with the use of DTC genetic kits, researchers can easily design and develop personalized medicine that would help in faster patient recovery. Aforementioned factor is expected to drive the industry growth. However, high cost of DTC genetic testing kits may hamper industry growth to some extent during the forecast period.

Market Segmentation, Outlook & Regional Insights: Direct-to-Consumer Genetic Testing Market

Direct-to-Consumer Genetic Testing Market, By Test Type

Predictive testing segment will experience around 17% growth throughout the analysis period. Considerable segmental growth can be associated with rising prevalence of genetic diseases. Recently developed DTC genetic tests help to identify mutations that increase the chances of acquiring specific disease accurately. Surging awareness regarding benefits of such presymptomatic testing has reduced the mortality rates by enabling effective management of disease. Above mentioned factors have stimulated the segmental growth that is predicted to continue over the forecast timeframe.

Ancestry and relationship testing segment accounted for over 43% revenue share in 2018. Increasing awareness regarding ethnicity tests amongst the American and European population has increased the demand for DTC genetic tests. Accuracy and efficiency possessed by these tests has fostered segmental growth. Moreover, ancestry tests developed by companies such as Ancestry.com are user friendly. Availability of robust DTC ancestry tests providing meaningful clinical, genealogical and even forensic information will positively impact the segment growth.

Direct-to-Consumer Genetic Testing Market, By Technology

Targeted analysis segment was valued over USD 310 million in 2018. Targeted analysis is utilized for determining the defects in genes that are responsible for a particular disorder. Targeted genotyping can accurately measure an individuals gene pool that encodes important information regarding various diseases. Targeted analysis can be conducted at significant low cost compared to other available techniques that should augment its adoption rate over forecast timeframe.

Single nucleotide polymorphism segment will experience around 15% growth throughout the forecast period. Single nucleotide polymorphism chips specifically detect changes in single nucleotide that increases the efficiency of tests. For instance, SNP chips utilized for diagnosing hereditary cancers have detected 1300 mutations in BRCA2 genes. Various companies such as Ancestry.com and Color Genomics utilize SNP arrays that analyse gene sequences at a specific resolution and reveal detailed analysis about the defective genes that may in future cause certain disease. Increasing adoption of such advanced SNP chips in DTC testing kits will trigger the segmental growth.

Germany DTC Genetic Testing Market Size, By Technology, 2018 (USD Million)

Direct-to-Consumer Genetic Testing Market, By Region

North America direct-to-consumer genetic testing market accounted for around 39% regional share in 2018. Regional market growth can be attributed to increasing prevalence of genetic diseases. Rare genetic diseases such as thalassemia, hemophilia and anaemia require continuous and critical monitoring. According to CDC, every year more than 1,000 people are affected by thalassemia. Furthermore, American population has higher literacy rate and also, awareness regarding DTC tests is high amongst the American population that augments demand for DTC genetic tests.

Europe is estimated to experience around 15% growth over the coming years. European direct-to-consumer genetic testing market is highly regulated and for carrying out some of the genetic tests through DTC kits, customers are required to have physicians prescription. However, currently, European regulatory bodies are working on improving regulations set on DTC tests due to improved accuracy and efficiency possessed by them. Thus, improvement in regulatory scenario will positively impact regional market growth.

Latin America DTC Genetic Testing Market Size, By Country, 2025 (USD Million)

Key Players, Recent Developments & Sector Viewpoints: Direct-to-Consumer Genetic Testing Market

Few of the eminent industry players operating in direct-to-consumer genetic testing market are Ancestry, 23andMe, Color, Family Tree DNA, EasyDNA, Helix, Identigene, Full Genomes, Genesis HealthCare, Karmagenes, MyHeritage, MapMyGenome, Living DNA and Pathway Genomics. Chief industry players implement numerous initiatives such as mergers, acquisitions and new product launch to maintain their market position. Receiving approvals from regulatory bodies for new products will also foster companys revenue share. For instance, in October 2018, 23andme received first U.S. FDA approval for de novotechnology utilized in pharmacogenomic tests. This approval will enable company to launch innovative products, thereby fostering companys growth.

Direct-to-Consumer (DTC) Genetic Testing Industry Viewpoint

Direct-to-consumer genetic testing industry can be traced back to early 2000s. Earlier DTC tests were thought to be convenient as they would allow the patients to access their genetic information without involvement of physician. Although, DTC genetic testing kits had several benefits, in the initial days, they were stringently regulated by regulatory bodies. Regulatory scenario has always been stringent since the introduction of DTC genetic kits in European countries. Currently, there has been change in the regulatory scenario and European countries have started receiving approval for DTC genetic kits. Defects in the DTC kits have been reduced and people have started relying on these kits. DTC genetic testing market is sort of matured in North America due to numerous technological advancements and is still in developing phase in Asian countries. With further advancements in technology, DTC genetic tests industry will experience numerous growth opportunitie

Key Insights Covered: Exhaustive Direct-to-Consumer Genetic Testing Market1. Market size (sales, revenue and growth rate) of Direct-to-Consumer Genetic Testing industry.2. Global major manufacturers operating situation (sales, revenue, growth rate and gross margin) of Direct-to-Consumer Genetic Testing industry.3. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of Direct-to-Consumer Genetic Testing industry.4. Market size (sales, revenue) forecast by regions and countries from 2019 to 2025 of Direct-to-Consumer Genetic Testing industry.

Research Methodology: Direct-to-Consumer Genetic Testing Market

Looking for more? Check out our repository for all available reports on Direct-to-Consumer Genetic Testing in related sectors.

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Trusted Business InsightsShelly ArnoldMedia & Marketing ExecutiveEmail Me For Any ClarificationsConnect on LinkedInClick to follow Trusted Business Insights LinkedIn for Market Data and Updates.US: +1 646 568 9797UK: +44 330 808 0580

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Direct-to-Consumer Genetic Testing Market: Trends, Applications, Industry Competitive Analysis, Growth,Forecast: 2019 to 2029 - The Scarlet

SAN DIEGO, Aug. 28, 2020 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) announced today that on August 26, 2020, it commenced mailing an open letter to stockholders in support of its proposal to increase authorized shares, a copy of which is included at the end of this press release.

Erik Holmlin, PhD, CEO of Bionano commented, We are fast approaching our stockholder meeting to be held on August 31, 2020. I want to thank the many stockholders whose input helped craft the strategy we are pursuing to increase our authorized shares without an accompanying reverse stock split. This increase in authorized shares is imperative and has been carefully considered after receiving abundant stockholder feedback. As of August 26, 2020, we had approximately 13.3 million available authorized shares, which we continue to believe is insufficient to meet our needs for future financings and strategic transactions as well as incentivize our key personnel. For this reason, and as further detailed in the enclosed letter to stockholders and the proxy statement for the special meeting, we ask that you vote For the proposal. If you have voted against this proposal, we ask that you consider the Companys urgent need and vote For the proposal.

Details of the Special Meeting of StockholdersThe special meeting of stockholders will be held virtually, via live webcast at http://www.virtualshareholdermeeting.com/BNGO2020, on Monday, August 31, 2020, at 10:00 a.m. Pacific Time. Stockholders of record as of July 27, 2020, may vote at the special meeting or by proxy over the telephone, through the internet or using the proxy card included in the proxy materials mailed to such stockholders. Stockholders may change their vote at any time before the final vote at the special meeting.

Details regarding voting procedures are included in the Companys proxy statement for the special meeting, filed with the U.S. Securities Commission on August 3, 2020.

About Bionano GenomicsBionano is a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing, and providing diagnostic testing for those with autism spectrum disorder (ASD) and other neurodevelopmental disabilities through its Lineagen business. Bionanos Saphyr system is a platform for ultra-sensitive and ultra-specific structural variation detection that enables researchers and clinicians to accelerate the search for new diagnostics and therapeutic targets and to streamline the study of changes in chromosomes, which is known as cytogenetics. The Saphyr system is comprised of an instrument, chip consumables, reagents and a suite of data analysis tools, and genome analysis services to provide access to data generated by the Saphyr system for researchers who prefer not to adopt the Saphyr system in their labs. Lineagen has been providing genetic testing services to families and their healthcare providers for over nine years and has performed over 65,000 tests for those with neurodevelopmental concerns. For more information, visitwww.bionanogenomics.com or http://www.lineagen.com.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, expect, plan, anticipate, estimate, intend and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the need for an increase in authorized shares of common stock from 200,000,000 shares to 400,000,000 shares and the potential negative impacts to the company if the corresponding proposal is not approved. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive products; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the loss of key members of management and our commercial team; and the risks and uncertainties associated withour business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

Letter to Stockholders

August 26, 2020

Dear Fellow Stockholder,

I am writing to ask for your support of the increase in authorized shares proposal (Proposal1) contained in the Definitive Proxy Statement for our Special Meeting of Stockholders to be held on August 31, 2020 at 10:00 a.m. Pacific Time. It is imperative for the future of the company that you, our stockholders, vote in favor of this proposal.

At the current level of authorized shares, Bionano Genomics is unable to confidently take the steps we feel are necessary to move the company forward in key strategic and financial areas. We believe the increase will enable us to, among other things, execute future potential equity financings, recruit and retain exceptional talent, and pursue potential strategic transactions.

I cannot emphasizeenough the importance of this share increase.

Without sufficient authorized shares, we believe that we will not be able to:

Therefore, I would again like to ask that you please support Proposal 1 as described in the Proxy Statement, which is for an increase in authorized shares without any reverse split component. We believe that doing so will give Bionano a much better chance of succeeding in its core mission.

Thank you.

Sincerely,

Erik HolmlinPresident and CEOBionano Genomics, Inc.

CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionanogenomics.com

Investor Relations Contact:Ashley R. RobinsonLifeSci Advisors, LLC+1 (617) 430-7577arr@lifesciadvisors.com

Media Contact:Darren Opland, PhD+1 (617) 733-7668darren@lifescicomms.com

See more here:
Bionano Genomics Emphasizes the Importance of Supporting the Proxy Proposal to Increase its Authorized Shares - GlobeNewswire

The Direct-To-Consumer (DTC) Genetic Testing market research encompasses an exhaustive analysis of the market outlook, framework, and socio-economic impacts. The report covers the accurate investigation of the market size, share, product footprint, revenue, and progress rate. Driven by primary and secondary researches, the Direct-To-Consumer (DTC) Genetic Testing market study offers reliable and authentic projections regarding the technical jargon.

All the players running in the global Direct-To-Consumer (DTC) Genetic Testing market are elaborated thoroughly in the Direct-To-Consumer (DTC) Genetic Testing market report on the basis of proprietary technologies, distribution channels, industrial penetration, manufacturing processes, and revenue. In addition, the report examines R&D developments, legal policies, and strategies defining the competitiveness of the Direct-To-Consumer (DTC) Genetic Testing market players.

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The key players covered in this studyAncestryColor GenomicsEasy DNAFamilytreeDNA (Gene By Gene)Full Genome CorporationHelix OpCo LLCIdentigeneKarmagenesLiving DNAMapmygenomeMyHeritagePathway GenomicsGenesis Healthcare23andMe

Market segment by Type, the product can be split intoCarrier TestingPredictive TestingAncestry & Relationship TestingNutrigenomics TestingOthersMarket segment by Application, split intoOnline PlatformsOver-the-Counter

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

The study objectives of this report are:To analyze global Direct-To-Consumer (DTC) Genetic Testing status, future forecast, growth opportunity, key market and key players.To present the Direct-To-Consumer (DTC) Genetic Testing development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by type, market and key regions.

In this study, the years considered to estimate the market size of Direct-To-Consumer (DTC) Genetic Testing are as follows:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year 2020 to 2026For the data information by region, company, type and application, 2019 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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Objectives of the Direct-To-Consumer (DTC) Genetic Testing Market Study:

The Direct-To-Consumer (DTC) Genetic Testing market research focuses on the market structure and various factors (positive and negative) affecting the growth of the market. The study encloses a precise evaluation of the Direct-To-Consumer (DTC) Genetic Testing market, including growth rate, current scenario, and volume inflation prospects, on the basis of DROT and Porters Five Forces analyses. In addition, the Direct-To-Consumer (DTC) Genetic Testing market study provides reliable and authentic projections regarding the technical jargon.

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Direct-To-Consumer (DTC) Genetic Testing Market Future Need Assessment 2028 - The News Brok

Global Direct-To-Consumer (DTC) Genetic Testing Market 2020 Global Industry Research Report is deep analysis by historical and current status of the market/industries for Global Direct-To-Consumer (DTC) Genetic Testing industry. Also, research report categorizes the global Direct-To-Consumer (DTC) Genetic Testing market by Segment by Player, Type, Application, Marketing Channel, and Region. Direct-To-Consumer (DTC) Genetic Testing Market report also tracks the latest market dynamics, such as driving factors, restraining factors, and industry news like mergers, acquisitions, and investments. Direct-To-Consumer (DTC) Genetic Testing Market Research Report provides market size (value and volume), market share, growth rate by types, applications, and combines both qualitative and quantitative methods to make micro and macro forecasts.

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The objective of the study is to define market sizes of different segments and countries in previous years and to forecast the values to the next Five years. The report is designed to incorporate both qualify qualitative and quantitative aspects of the industry with respect to each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as drivers and restraining factors which will define the future growth of the Direct-To-Consumer (DTC) Genetic Testing market.

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The research covers the current Direct-To-Consumer (DTC) Genetic Testing market size of the market and its growth rates based on 6-year records with company outline of Key players/manufacturers:

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Short Description about Direct-To-Consumer (DTC) Genetic Testing Market:

The report also focuses on global major leading industry players of Global Direct-To-Consumer (DTC) Genetic Testing market providing information such as company profiles, product picture and specification, capacity, production, price, cost, revenue and contact information. This report focuses on Direct-To-Consumer (DTC) Genetic Testing Market Trend, volume and value at global level, regional level and company level. From a global perspective, this report represents overall Direct-To-Consumer (DTC) Genetic Testing Market Size by analyzing historical data and future prospect.

The global Direct-To-Consumer (DTC) Genetic Testing Market is anticipated to rise at a considerable rate during the forecast period, between 2020 and 2026. In 2020, the market was growing at a steady rate and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

The Direct-To-Consumer (DTC) Genetic Testing market is expected to grow at a Highest CAGR during the forecast period 2020-2026.

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

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Geographically, this report is segmented into several key regions, with sales, revenue, market share and growth Rate of Direct-To-Consumer (DTC) Genetic Testing in these regions, from 2020 to 2026, covering

This Direct-To-Consumer (DTC) Genetic Testing Market Research/Analysis Report Contains Answers to your following Questions

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Major Points from Table of Contents:

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Direct-To-Consumer (DTC) Genetic Testing Revenue1.4 Market Analysis by Type1.4.1 Global Direct-To-Consumer (DTC) Genetic Testing Market Size Growth Rate by Type: 2020 VS 20261.4.2 Carrier Testing1.4.3 Predictive Testing1.4.4 Ancestry & Relationship Testing1.4.5 Nutrigenomics Testing1.4.6 Others1.5 Market by Application1.5.1 Global Direct-To-Consumer (DTC) Genetic Testing Market Share by Application: 2020 VS 20261.5.2 Online Platforms1.5.3 Over-the-Counter1.6 Coronavirus Disease 2019 (Covid-19): Direct-To-Consumer (DTC) Genetic Testing Industry Impact1.6.1 How the Covid-19 is Affecting the Direct-To-Consumer (DTC) Genetic Testing Industry1.6.1.1 Direct-To-Consumer (DTC) Genetic Testing Business Impact Assessment Covid-191.6.1.2 Supply Chain Challenges1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products1.6.2 Market Trends and Direct-To-Consumer (DTC) Genetic Testing Potential Opportunities in the COVID-19 Landscape1.6.3 Measures / Proposal against Covid-191.6.3.1 Government Measures to Combat Covid-19 Impact1.6.3.2 Proposal for Direct-To-Consumer (DTC) Genetic Testing Players to Combat Covid-19 Impact1.7 Study Objectives1.8 Years Considered

2 Global Growth Trends by Regions2.1 Direct-To-Consumer (DTC) Genetic Testing Market Perspective (2015-2026)2.2 Direct-To-Consumer (DTC) Genetic Testing Growth Trends by Regions2.2.1 Direct-To-Consumer (DTC) Genetic Testing Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Direct-To-Consumer (DTC) Genetic Testing Historic Market Share by Regions (2015-2020)2.2.3 Direct-To-Consumer (DTC) Genetic Testing Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Direct-To-Consumer (DTC) Genetic Testing Market Growth Strategy2.3.6 Primary Interviews with Key Direct-To-Consumer (DTC) Genetic Testing Players (Opinion Leaders)

3 Competition Landscape by Key Players3.1 Global Top Direct-To-Consumer (DTC) Genetic Testing Players by Market Size3.1.1 Global Top Direct-To-Consumer (DTC) Genetic Testing Players by Revenue (2015-2020)3.1.2 Global Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Players (2015-2020)3.1.3 Global Direct-To-Consumer (DTC) Genetic Testing Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Direct-To-Consumer (DTC) Genetic Testing Market Concentration Ratio3.2.1 Global Direct-To-Consumer (DTC) Genetic Testing Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Direct-To-Consumer (DTC) Genetic Testing Revenue in 20193.3 Direct-To-Consumer (DTC) Genetic Testing Key Players Head office and Area Served3.4 Key Players Direct-To-Consumer (DTC) Genetic Testing Product Solution and Service3.5 Date of Enter into Direct-To-Consumer (DTC) Genetic Testing Market3.6 Mergers & Acquisitions, Expansion Plans

4 Breakdown Data by Type (2015-2026)4.1 Global Direct-To-Consumer (DTC) Genetic Testing Historic Market Size by Type (2015-2020)4.2 Global Direct-To-Consumer (DTC) Genetic Testing Forecasted Market Size by Type (2021-2026)

5 Direct-To-Consumer (DTC) Genetic Testing Breakdown Data by Application (2015-2026)5.1 Global Direct-To-Consumer (DTC) Genetic Testing Market Size by Application (2015-2020)5.2 Global Direct-To-Consumer (DTC) Genetic Testing Forecasted Market Size by Application (2021-2026)

6 North America6.1 North America Direct-To-Consumer (DTC) Genetic Testing Market Size (2015-2020)6.2 Direct-To-Consumer (DTC) Genetic Testing Key Players in North America (2019-2020)6.3 North America Direct-To-Consumer (DTC) Genetic Testing Market Size by Type (2015-2020)6.4 North America Direct-To-Consumer (DTC) Genetic Testing Market Size by Application (2015-2020)

7 Europe7.1 Europe Direct-To-Consumer (DTC) Genetic Testing Market Size (2015-2020)7.2 Direct-To-Consumer (DTC) Genetic Testing Key Players in Europe (2019-2020)7.3 Europe Direct-To-Consumer (DTC) Genetic Testing Market Size by Type (2015-2020)7.4 Europe Direct-To-Consumer (DTC) Genetic Testing Market Size by Application (2015-2020)

8 China8.1 China Direct-To-Consumer (DTC) Genetic Testing Market Size (2015-2020)8.2 Direct-To-Consumer (DTC) Genetic Testing Key Players in China (2019-2020)8.3 China Direct-To-Consumer (DTC) Genetic Testing Market Size by Type (2015-2020)8.4 China Direct-To-Consumer (DTC) Genetic Testing Market Size by Application (2015-2020)

9 Japan9.1 Japan Direct-To-Consumer (DTC) Genetic Testing Market Size (2015-2020)9.2 Direct-To-Consumer (DTC) Genetic Testing Key Players in Japan (2019-2020)9.3 Japan Direct-To-Consumer (DTC) Genetic Testing Market Size by Type (2015-2020)9.4 Japan Direct-To-Consumer (DTC) Genetic Testing Market Size by Application (2015-2020)

10 Southeast Asia10.1 Southeast Asia Direct-To-Consumer (DTC) Genetic Testing Market Size (2015-2020)10.2 Direct-To-Consumer (DTC) Genetic Testing Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Direct-To-Consumer (DTC) Genetic Testing Market Size by Type (2015-2020)10.4 Southeast Asia Direct-To-Consumer (DTC) Genetic Testing Market Size by Application (2015-2020)

11 India11.1 India Direct-To-Consumer (DTC) Genetic Testing Market Size (2015-2020)11.2 Direct-To-Consumer (DTC) Genetic Testing Key Players in India (2019-2020)11.3 India Direct-To-Consumer (DTC) Genetic Testing Market Size by Type (2015-2020)11.4 India Direct-To-Consumer (DTC) Genetic Testing Market Size by Application (2015-2020)

12 Central & South America12.1 Central & South America Direct-To-Consumer (DTC) Genetic Testing Market Size (2015-2020)12.2 Direct-To-Consumer (DTC) Genetic Testing Key Players in Central & South America (2019-2020)12.3 Central & South America Direct-To-Consumer (DTC) Genetic Testing Market Size by Type (2015-2020)12.4 Central & South America Direct-To-Consumer (DTC) Genetic Testing Market Size by Application (2015-2020)

13Key Players Profiles13.1 Ancestry13.1.1 Ancestry Company Details13.1.2 Ancestry Business Overview and Its Total Revenue13.1.3 Ancestry Direct-To-Consumer (DTC) Genetic Testing Introduction13.1.4 Ancestry Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020))13.1.5 Ancestry Recent Development13.2 Color Genomics13.2.1 Color Genomics Company Details13.2.2 Color Genomics Business Overview and Its Total Revenue13.2.3 Color Genomics Direct-To-Consumer (DTC) Genetic Testing Introduction13.2.4 Color Genomics Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)13.2.5 Color Genomics Recent Development13.3 Easy DNA13.3.1 Easy DNA Company Details13.3.2 Easy DNA Business Overview and Its Total Revenue13.3.3 Easy DNA Direct-To-Consumer (DTC) Genetic Testing Introduction13.3.4 Easy DNA Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)13.3.5 Easy DNA Recent Development13.4 FamilytreeDNA (Gene By Gene)13.4.1 FamilytreeDNA (Gene By Gene) Company Details13.4.2 FamilytreeDNA (Gene By Gene) Business Overview and Its Total Revenue13.4.3 FamilytreeDNA (Gene By Gene) Direct-To-Consumer (DTC) Genetic Testing Introduction13.4.4 FamilytreeDNA (Gene By Gene) Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)13.4.5 FamilytreeDNA (Gene By Gene) Recent Development13.5 Full Genome Corporation13.5.1 Full Genome Corporation Company Details13.5.2 Full Genome Corporation Business Overview and Its Total Revenue13.5.3 Full Genome Corporation Direct-To-Consumer (DTC) Genetic Testing Introduction13.5.4 Full Genome Corporation Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)13.5.5 Full Genome Corporation Recent Development13.6 Helix OpCo LLC13.6.1 Helix OpCo LLC Company Details13.6.2 Helix OpCo LLC Business Overview and Its Total Revenue13.6.3 Helix OpCo LLC Direct-To-Consumer (DTC) Genetic Testing Introduction13.6.4 Helix OpCo LLC Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)13.6.5 Helix OpCo LLC Recent Development13.7 Identigene13.7.1 Identigene Company Details13.7.2 Identigene Business Overview and Its Total Revenue13.7.3 Identigene Direct-To-Consumer (DTC) Genetic Testing Introduction13.7.4 Identigene Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)13.7.5 Identigene Recent Development13.8 Karmagenes13.8.1 Karmagenes Company Details13.8.2 Karmagenes Business Overview and Its Total Revenue13.8.3 Karmagenes Direct-To-Consumer (DTC) Genetic Testing Introduction13.8.4 Karmagenes Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)13.8.5 Karmagenes Recent Development13.9 Living DNA13.9.1 Living DNA Company Details13.9.2 Living DNA Business Overview and Its Total Revenue13.9.3 Living DNA Direct-To-Consumer (DTC) Genetic Testing Introduction13.9.4 Living DNA Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)13.9.5 Living DNA Recent Development13.10 Mapmygenome13.10.1 Mapmygenome Company Details13.10.2 Mapmygenome Business Overview and Its Total Revenue13.10.3 Mapmygenome Direct-To-Consumer (DTC) Genetic Testing Introduction13.10.4 Mapmygenome Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)13.10.5 Mapmygenome Recent Development13.11 MyHeritage10.11.1 MyHeritage Company Details10.11.2 MyHeritage Business Overview and Its Total Revenue10.11.3 MyHeritage Direct-To-Consumer (DTC) Genetic Testing Introduction10.11.4 MyHeritage Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)10.11.5 MyHeritage Recent Development13.12 Pathway Genomics10.12.1 Pathway Genomics Company Details10.12.2 Pathway Genomics Business Overview and Its Total Revenue10.12.3 Pathway Genomics Direct-To-Consumer (DTC) Genetic Testing Introduction10.12.4 Pathway Genomics Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)10.12.5 Pathway Genomics Recent Development13.13 Genesis Healthcare10.13.1 Genesis Healthcare Company Details10.13.2 Genesis Healthcare Business Overview and Its Total Revenue10.13.3 Genesis Healthcare Direct-To-Consumer (DTC) Genetic Testing Introduction10.13.4 Genesis Healthcare Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)10.13.5 Genesis Healthcare Recent Development13.14 23andMe10.14.1 23andMe Company Details10.14.2 23andMe Business Overview and Its Total Revenue10.14.3 23andMe Direct-To-Consumer (DTC) Genetic Testing Introduction10.14.4 23andMe Revenue in Direct-To-Consumer (DTC) Genetic Testing Business (2015-2020)10.14.5 23andMe Recent Development

14Analysts Viewpoints/Conclusions

15Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details

Continued..

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Direct-To-Consumer (DTC) Genetic Testing Market 2020 Global Industry Size, Recent Trends, Demand and Share Estimation by 2026 with Top Players...

Impact Analysis of Covid-19

The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.

The Direct-to-Consumer Genetic Testing Devices market demand is anticipated to flourish during the forecast period 2018-2026. The report offers information related to import and export, along with the current business chain in the market at the global level. This report provides an in-depth overview of the Direct-to-Consumer Genetic Testing Devices market. This includes market characteristics, consisting of segmentation, market share, trends and strategies for this market. The Market Size section provides historical forecasts of market growth and future. An in-depth analysis of the major companies operating in the market is also mentioned in this research report.

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The global Direct-to-Consumer Genetic Testing Devices market is segmented on the basis of type and application.

It also provides market size and forecast estimates from the year 2018 to 2026 with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East & Africa (MEA), and South America (SAM). The Direct-to-Consumer Genetic Testing Devices market by each region is later sub-segmented by respective countries and segments. The report covers the analysis and forecast of top countries globally along with the current trend and opportunities prevailing in the region.

A thorough examination of the Direct-to-Consumer Genetic Testing Devices market includes each and every aspect, which begins with knowing the market, speaking with clients, and evaluating the complete data of the global market. For more clarification, the global market is segmented on the basis of the manufacture of the kind of products, and their applications. The report also delivers information as per the regions based on the geographical classification of the global Direct-to-Consumer Genetic Testing Devices market. The dynamic foundation of the global market is based on the calculation of product supply in different markets, their revenues, capability, and a chain of production.

Qualitative information will discuss the key factors driving the restraining the growth of the market, and the possible growth opportunities of the market, regulatory scenario, value chain & supply chain analysis, export & import analysis, attractive investment proposition, and Porters 5 Forces analysis among others will be a part of qualitative information.

Competitive Section

Key players operating the Direct-to-Consumer Genetic Testing Devices market are Pathway Genomics, Color Genomics, Counsyl, Inc., deCode genetics, Inc., Map My Gene, and GenePartner.

Furthermore, this study will help our clients solve the following issues:

Market dynamics- The study foresees dynamics of industries by using core analytical and unconventional market research approaches. This will help clients to use this insight provided to maneuver themselves through market uncertainties and disruptions

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All in all, the Direct-to-Consumer Genetic Testing Devices market research study elucidates a detailed evaluation of this business and projects this industry to register a commendable growth rate in the forthcoming years. The Direct-to-Consumer Genetic Testing Devices market analysis report also delivers important insights with respect to aspects such as the volume of sales, valuation forecast, market size, and the market competition trends as well as the market concentration rate.

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Direct-to-Consumer Genetic Testing Devices Market Forecast 2026 By Industry Size and Share, Demand, Worldwide Research, Prominent Players, Emerging...

The research report on the global Genetic Testing Market offers an all-encompassing analysis of recent and upcoming states of this industry which also analyzes several growth strategies for market growth. The Genetic Testing report also focuses on the comprehensive study of the industry environment, and industry chain structure extensively. The Genetic Testing report also sheds light on major factors including leading vendors, growth rate, production value, and key regions.

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Top Key Players:

HI GeneRegulatoryAnnoroadSinoGenoMaxGenePlanetCounsyl, Inc.RepconexNatera, IncBiomarkerGeeppine360Jiyin23andMe, IncCapitalBioBiomedlabGene by GeneUnited GeneGeneDxFind Bio-TechAiyin GeneCourtagen Life SciencesAgenGeneTestsAsper BiotechPathway GenomicsNovogeneBGIGene KangBerry GenomicsAijiyin

Genetic Testing Market Fragment by Areas, regional examination covers

United States, Canada, Germany, UK, France, Italy, Russia, Switzerland, Sweden, Poland, , China, Japan, South Korea, Australia, India, Taiwan, Thailand, Philippines, Malaysia, Brazil, Argentina, Columbia, Chile, Saudi Arabia, UAE, Egypt, Nigeria, South Africa and Rest of the World.

The Genetic Testing Market report introduces the industrial chain analysis, downstream buyers, and raw material sources along with the correct comprehensions of market dynamics. The Genetic Testing Market report is articulated with a detailed view of the Global Genetic Testing industry including Global production sales, Global revenue, and CAGR. Additionally, it offers potential insights about Porters Five Forces including substitutes, buyers, industry competitors, and suppliers with genuine information for understanding the Global Genetic Testing Market.

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Market segment by Type, the product can be split into:

CancerCystic fibrosisSickle cell anemiaDuchenne muscular dystrophyAlzheimer diseaseThalassemiaHuntington diseaseOthers

Market segment by Application, split into:

Newborn screeningDiagnostic testingCarrier testingPreimplantation genetic diagnosisPrenatal diagnosisPredictive and presymptomatic testingPharmacogenomics

The Genetic Testing Market study projects viability analysis, SWOT analysis, and various other information about the leading companies operating in the Global Genetic Testing Market provide a complete efficient account of the viable environment of the industry with the aid of thorough company profiles. However, Genetic Testing research examines the impact of current market success and future growth prospects for the industry.

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In this study, the years considered to estimate the market size of Genetic Testing are as follows:

Table of Contents:

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Global Genetic Testing Market Report Reviews Trends, Revenue, Size, Share, Growth opportunities, Competitive Landscape Analysis And Forecast to 2026 -...

Scholar advocates expanding federal legal protections against genetic discrimination.

For two decades, police unsuccessfully searched for a Los Angeles serial killer who murdered several people over a span of three years. The killings remained a mystery until the murderercommonly referred to as the Grim Sleeperstruck again 14 years later.

That time, authorities used a technique called familial DNA searching and found that the serial killer was related to a man who had undergone genetic testing and was already in a police database. This genetic information allowed authorities to narrow the list of suspects, ultimately leading them to a conviction for 12 murders.

Although stories such as that of the Grim Sleeper highlight the benefits that can come from increased access to genetic information, one scholar argues that stricter legal protections are needed to ensure that the information gathered through genetic testing cannot be used improperly by private firms, such as insurers, as a means to discriminate against consumers.

In a recent article, Michael Dohn of Belmont University College of Law argues that the federal law under The Genetic Information Nondiscrimination Act of 2008 (GINA) needs to be expanded to prevent genetic information from being used to determine placement in schools as well as eligibility for life, disability, and long-term care insurance.

Currently, GINA prohibits employers from using genetic test results to determine compensation or make hiring decisions, Dohn explains. The Act also bars health insurance companies from using genetic information to determine eligibility, premiums, and contributions.

Although GINA provides these legal protections from genetic discrimination in the workplace and health insurance markets, it does nothing to prevent life, disability, and long-term care insurance companies from using genetic test results to determine eligibility. Dohn points to one illustrative case in which an insurance company legally denied a young woman life insurance simply because she admitted to testing positive for a gene that indicated she had an increased risk of developing breast cancer.

Genetic test results can also be used to determine school placement. Dohn highlights a recently settled California case in which a school district transferred a student to another school after his parents submitted school forms indicating the student was a carrier for cystic fibrosis. The school determined the student should be transferred to reduce the risk that other students with cystic fibrosis would get an infection from a carrier of the disease.

If the court in this case had determined that carriers for genetic diseases were not protected under a federal law that prevents discrimination based on disability, the school district might have been able to use the students genetic information to decide where the student could go to school, Dohn worried.

Genetic test results that reveal an individuals biological sex might also be used to discriminate against transgender people, although a recent U.S. Supreme Court decision held that discrimination based on gender identity in cases where a persons gender identity may not match their biological sex is prohibited under federallaw as sex discrimination.

Individuals genetic test results can become available for discriminatory use when consumers submit samples of saliva or cheek swabs to companies that provide direct-to-consumer genetic testingsuch as 23andMe or Ancestry.com. These companies can use the genetic material in the sample to provide customers with information about their ancestry or health, such as increased risk of developing certain diseases, Dohn says. Although he recognizes that genetic information can provide consumers with both medical and entertainment value, Dohn warns that serious concerns still exist about who can access genetic test results.

With rapid advancements in the field of genetics, Dohn suggests that professionals could use the raw data from the genetic test results to uncover a consumers personal health information. Hackers could also access personal health information through cyber-attacks targeting genetic testing companies, he explains.

Some of the direct-to-consumer genetic testing companies also share consumer information with third-party research groups, Dohn says. Although the genetic testing companies remove identifying personal information before sharing, researchers have demonstrated that someone who is given an individuals raw genetic data and basic demographic information for that individual can use this information to identify the individual.

Dohn also points out that consumers may directly provide third parties with access to their genetic information by agreeing to undergo genetic testing or by publicly sharing their test results. When consumers share their genetic information, however, they are often unaware that this information can then be used to deny them services or access to facilities, Dohn argues.

To protect consumers and prevent third parties from discriminating based on genetic information, Dohn says that GINA needs to be expanded to fill the gaps where consumers are left unprotected.

He recognizes that opponents to expanding GINA argue that there are few documented cases of discrimination to date, and that state laws may be able to provide additional protections if there are concerns about discrimination in areas unprotected by federal legislation. But he responds that, as technology advances and scientists better understand how genetic information relates to diseases, individuals will become more vulnerable to discrimination based on the results of genetic tests.

Without an expansion to GINA, states alone cannot protect individuals from discrimination, Dohn says. He argues that state regulations vary in how much protection to give genetic information, creating a need for Congress to impose a uniform standard capable of adapting to advancements in the field of genetics.

The ever-increasing access to information should be accompanied with ever-expanding protections, Dohn concludes.

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Regulating the Use of Genetic Information - The Regulatory Review

Predictive Genetic Testing and Consumer/Wellness Genomics Market: Snapshot

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

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

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

The benefits of predictive genetic testing are

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Companies mentioned in the research report

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

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PREDICTIVE GENETIC TESTING AND CONSUMER/WELLNESS GENOMICS MARKET TRENDS AND DYNAMIC 2025 - Scientect

Thursday, August 27, 2020

Does payer coverage of genomic testing drive utilization? That is the question The Personalized Medicine Coalition (PMC) asked and answered in its recent report Understanding Genomic Testing Utilization and Coverage in the US (Study). PMCs Study, conducted in collaboration with BlueCross/BlueShield Association, Concert Genetics, and Illumina, sought to uncover patterns between the clinical use of genomic testing and payer coverage. Three clinical areas were studied: noninvasive prenatal testing (NIPT) in prenatal screening, whole exome sequencing (WES) in patients with rare and undiagnosed genetic diseases, and comprehensive genomic profiling (CGP) of tumors in patients with advanced cancer.

Four key findings were highlighted in the Study.1In sum, payer coverage of medically appropriate genomic tests is increasing, but this increase in coverage did not correspond with higher utilization of testing across the United States. As such, medically appropriate genetic testing was inconsistently utilized across the United States. While inconsistent coverage and reimbursement policies are barriers to patient access to testing, the Study concluded that these policies do not entirely explain inconsistent test utilization. Other utilization barriers were identified for further attention.

The Study acknowledged that obtaining payer coverage and reimbursement for genomic testing is one of several challenges to providing patients access to these medically important tests.2However, other challenges were identified that prevent full test access. These included a lack of clarity and consistency of payer coverage policies within and between states and across clinical areas. Identified barriers to test utilization were: socioeconomic determinants of health (such as the distance patients must travel to access genomic medical specialists), cultural and community factors (including known racial and ethnic health disparities across the health care systems), and data security and privacy concerns. Lack of awareness, knowledge and education of personalized medicine among health care providers and patients were also identified as ongoing challenges to full test utilization.

There is no doubt that research and development of personalized medicine diagnostics and therapies have been increasing but room for improvement remains. As noted by the Study:

Over the last 20 years, a steadily growing number of genetic biomarkers that contribute to disease have been discovered. New targeted therapies being developed to improve outcomes for responder patients add to this value proposition. However, utilization rates for medically appropriate NIPT, WES, and CGP genomic testing are inconsistent and variable even when favorable coverage policies exist. The full value of genomic testing cannot be realized unless utilization increases."3

The authors of the Study encourage proponents of personalized medicine to continue to develop and disseminate evidence supporting the clinical and economic benefits of genomic testing. Additional studies that evaluate each identified barrier and its impact on access and utilization will help address and remove barriers to access for every patient that needs it.

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1Study at page 5.2Study at page 21.3Study at page 22.

2020 Foley & Lardner LLPNational Law Review, Volume X, Number 240

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Payer Coverage Drive Genomic Test Utilization in the US? - The National Law Review

The research report on the global DTC Genetic Testing Market offers an all-encompassing analysis of recent and upcoming states of this industry which also analyzes several growth strategies for market growth. The DTC Genetic Testing report also focuses on the comprehensive study of the industry environment, and industry chain structure extensively. The DTC Genetic Testing report also sheds light on major factors including leading vendors, growth rate, production value, and key regions.

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Top Key Players:

Color GenomicsLaboratory Corporation of AmericaMapMyGenomeGene by Gene23andMeAfrican AncestryHelixWeGeneMyriad GeneticsPathway GenomicsQuest DiagnosticsThermo Fisher

DTC Genetic Testing Market Fragment by Areas, regional examination covers

United States, Canada, Germany, UK, France, Italy, Russia, Switzerland, Sweden, Poland, , China, Japan, South Korea, Australia, India, Taiwan, Thailand, Philippines, Malaysia, Brazil, Argentina, Columbia, Chile, Saudi Arabia, UAE, Egypt, Nigeria, South Africa and Rest of the World.

The DTC Genetic Testing Market report introduces the industrial chain analysis, downstream buyers, and raw material sources along with the correct comprehensions of market dynamics. The DTC Genetic Testing Market report is articulated with a detailed view of the Global DTC Genetic Testing industry including Global production sales, Global revenue, and CAGR. Additionally, it offers potential insights about Porters Five Forces including substitutes, buyers, industry competitors, and suppliers with genuine information for understanding the Global DTC Genetic Testing Market.

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Market segment by Type, the product can be split into:

Disease Risk and HealthAncestry or GenealogyKinshipLifestyle

Market segment by Application, split into:

On-line SalesDoctors Office

The DTC Genetic Testing Market study projects viability analysis, SWOT analysis, and various other information about the leading companies operating in the Global DTC Genetic Testing Market provide a complete efficient account of the viable environment of the industry with the aid of thorough company profiles. However, DTC Genetic Testing research examines the impact of current market success and future growth prospects for the industry.

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In this study, the years considered to estimate the market size of DTC Genetic Testing are as follows:

Table of Contents:

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Global DTC Genetic Testing Market Trends, Key Players, Overview, Competitive Breakdown and Regional Forecast by 2026 - Scientect

SAN CARLOS, Calif., Aug. 27,2020 /PRNewswire/ --Natera, Inc.(NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, today announced a collaborative agreement with Mass General Cancer Center (MGCC) of Massachusetts General Hospital, related to an investigator-initiated multi-center, Phase II randomized clinical trial of Ribociclib (Kisqali), a CDK4/6 inhibitor, for the treatment of ER-positive breast cancer (LEADER), the first circulating tumor DNA (ctDNA)-based study of a CDK4/6 inhibitor in ER-positive early stage breast cancer.

LEADER (part II) will randomize patients who have localized post-menopausal breast cancer with detectable ctDNA after surgery as evidence of minimal residual disease (MRD), and will determine tumor molecular response after Ribociclib in combination with endocrine therapy versus endocrine therapy alone. Natera's Signateratest will be used to determine patient enrollment eligibility based on presence of ctDNA via longitudinal monitoring and to evaluate response based on ctDNA clearance as the primary endpoint.

"With the overwhelming evidence that patients with detectable ctDNA are at high risk for relapse, our goal is to investigate a new treatment strategy for these patients and reduce risk of disease recurrence," said Aditya Bardia, MD, MPH, the study's principal investigator from MGCC, Harvard Medical School. "Since the LEADER trial is in the MRD setting, it is critical to use a highly sensitive assay."

Breast cancer remains the second leading cause of cancer death in women in the United States,1 and the U.S. Food and Drug Administration (FDA) has approved Ribociclib in combination with aromatase inhibitors as a first-line treatment option for advanced/metastatic (stage IV) disease.

"We are proud to partner with Massachusetts General Hospital on this exciting new approach of using Signatera personalized ctDNA analysis for enrollment and evaluation of treatment response to CDK4/6 inhibitors in the MRD setting," said Alexey Aleshin, MD, MBA, Natera's Senior Medical Director for Oncology."We believe this collaboration may pave the way for more trials using ctDNA to study the effectiveness of an investigational drug in early stage breast cancer."

About Signatera

Signatera is a custom-built ctDNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual's tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera's test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers.Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Natera

Naterais a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to oncologists, obstetricians, and transplant physicians, as well as to researchers and biopharmaceutical companies. For more information, visit natera.com. Follow Natera on LinkedIn.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at http://www.natera.com/investorsand http://www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350Media: Paul Greenland, VP of Corporate Marketing, [emailprotected]

References

1. How Common Is Breast Cancer? The American Cancer Society. Updated January 8,2020. Accessed July 14, 2020. https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html.

SOURCE Natera, Inc.

http://www.natera.com

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Natera Announces Collaboration with Massachusetts General Hospital for a Prospective Randomized Clinical Trial in Early Stage Breast Cancer -...

DALLAS--(BUSINESS WIRE)--Avero Diagnostics, a physician-owned laboratory, is pleased to announce the expansion of its COVID-19 testing portfolio with the addition of the Roche Elecsys Anti-SARS-CoV-2 antibody test. Serological testing supports the Centers for Disease Control and Prevention (CDC) efforts to more accurately understand how many people have been infected with SARS-CoV-2, the virus that causes COVID-19, and how it is spreading. This offering, available now, will complement Averos existing COVID-19 molecular testing program, which Avero launched in May 2020 to support the diagnostic needs of area hospitals, health systems, multi-specialty family practices, urgent care centers, and county health departments.

As the medical and scientific communities work to understand and stop the spread of COVID-19, serological testing serves as a piece of the very complex puzzle, said Trae Mattison, MD, Managing Partner, Avero Diagnostics. By expanding our COVID-19 testing services, we are not only supporting the need for serology testing in our community, we are also contributing to the national effort to understand the spread of the SARS-CoV-2 virus.

A serological test, often called antibody testing, is used to determine whether a person may have had a past infection with the virus that causes COVID-19. This test uses a blood sample to provide qualitative detection of high-affinity antibodies to SARS-CoV-2, to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. This assay enriches detection of higher affinity antibodies which are more likely to be specific for SARS-CoV-2. While this assay in principle can detect antibodies of all isotypes (i.e., IgG, IgA, IgM), it preferentially detects IgG antibodies. This test is recommended for individuals 14 days post-symptom onset, or five to seven days following exposure to individuals with confirmed COVID-19.

Avero Diagnostics CLIA-certified and CAP-accredited laboratory is using the Roche immunoassay for the qualitative detection of antibodies against SARS-CoV-2. The test is an electro-chemiluminescence immunoassay with 99.8% specificity. Avero can initially process approximately 800 tests per day, with the potential to scale up capacity based on demand. Avero expects to provide results to ordering providers within 24 to 48 hours.

For more information, visit http://www.averodx.com.

About Avero Diagnostics

Avero Diagnostics is a physician-owned laboratory and an affiliate of Progenity, Inc. (Nasdaq: PROG), dedicated to providing high quality anatomic pathology, molecular pathology, and genetic testing services to physicians and their patients. Avero Diagnostics provides sub-specialized pathology services in the areas of breast, gynecologic, gastrointestinal, molecular, and urologic pathology. The company also offers specialized testing services in genetic carrier testing and noninvasive prenatal screening. Avero is focused on improving healthcare delivery to patients through the research and development of novel diagnostic equipment and assays, offering a faster and more accurate result. Avero Diagnostics vision is to lead the healthcare industry in the delivery of anatomic pathology, molecular pathology and genetic testing. For more information, please visit http://www.averodx.com.

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Avero Diagnostics Expands COVID-19 Testing Capabilities with Launch of Serology Testing - Business Wire