Archive for the ‘Genetic Testing’ Category

Im proud of these labs for being so forward-thinking about ease of use and clinician experience. Feyi Ayodele CEO of CancerIQ

CHICAGO (PRWEB) November 19, 2020

CancerIQ, an enterprise precision health platform for cancer, has formed a network of trusted genetic labs to streamline and inform the genetic test ordering process. The CancerIQ Lab Network increases access to genetic testing and improves the experience for providers and genetic testing labs.

Democratizing access to genetic testing is one of the main tenets of precision health. Genetic testing helps providers identify patients at high risk of developing cancer to establish care plans to preempt a diagnosis.

Unfortunately, the vast majority of patients who meet guidelines for genetic testing go untested. Thats due to several barriers, including workflow issues, lack of awareness, confusion over guidelines, and reimbursement concerns.

CancerIQ added a Lab Network to its offerings to overcome those barriers. The network is a strategic alliance of genetic testing labs that recognize the hurdles and want to improve awareness and adoption of genetic testing.

The five anchor members of the CancerIQ Lab Network are Eurofins EGL Genetic Diagnostics, Eurofins NTD, Invitae, LabCorp and Myriad Genetics.

Im proud of these labs for being so forward-thinking about ease of use and clinician experience, says Feyi Ayodele, CEO of CancerIQ. This network makes genetic testing more scalable and accessible to patients.

Lab Network members are listed within the CancerIQ platform. Clinicians see the list at the point of care, which increases awareness of lab offerings and streamlines the test ordering process. If a test is selected by the healthcare provider, CancerIQ prepopulates the test requisition and insurance prior authorization forms with data collected during the patient encounter.

CancerIQ is also integrated into health systems EHRs, further streamlining the ordering process without extra cost or effort from the labs.

Provider organizations that were early adopters of the CancerIQ Lab Network found that the increased convenience and streamlined workflow enhanced ordering and utilization of tests for appropriate patients.

Additionally, patients had more tests covered by insurance because the CancerIQ platform accurately and thoroughly captures necessary clinical information to avoid a denial.

About CancerIQ CancerIQ's precision health platform enables hospitals to identify, evaluate and manage entire patient populations based on individual genetic risk factors. By analyzing family history, running predictive risk models and automating NCCN guidelines, CancerIQ empowers providers with the genetic expertise to prevent cancer or catch it early. The platform has been rapidly adopted by some of the top health systems in the country and fully integrates with genetics laboratories, EHRs, and specialty software vendors to streamline workflow, guide clinician decision making, achieve cost savings, and most importantly improve patient outcomes.

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CancerIQ Officially Launches Lab Network to Increase Awareness and Accelerate Adoption of Genetic Testing - PR Web

PHOENIX Genetic testing can uncover inherited genetic mutations, and could individualize cancer therapies, improve survival, manage cancer in loved ones and push the boundaries of precision medicine.

In a new study published in JAMA Oncology, scientists with Mayo Clinic's Center for Individualized Medicine conducted genetic testing in more than 3,000 patients who were diagnosed with cancer at Mayo Clinic Cancer Center locations in Arizona, Florida and Minnesota. In all, the scientists found that 1 in 8 patients with cancer had an inherited cancer-related gene mutation. This mutation would not have been detected in half of these patients using a standard guideline-based approach.

"We found that 13.5% of patients had an inherited mutation in a gene associated with the development of their cancer," says Niloy Jewel Samadder, M.D., a Mayo Clinic gastroenterologist and hepatologist, who is the study's author. "Everyone has some risk of developing cancer, and in most cases the disease develops by chance. However, some people are genetically predisposed to developing certain types of cancer, such as breast or colon cancers."

A genetic mutation can cause a gene to malfunction and lead to a cell becoming cancerous. Although many mutations that cause cancer happen by chance in a single cell, the study confirms that nearly 10%-25% are inherited mutations that set off a cycle of events that can lead to cancer.

Niloy Jewel Samadder, M.D.Dr. Samadder says uncovering these hidden inherited genetic mutations could lead to opportunities for cancer management in families and targeted cancer therapies that can save lives.

In the two-year Interrogating Cancer Etiology Using Proactive Genetic Testing (INTERCEPT) study, Mayo Clinic provided free genetic testing and counseling to 3,084 Mayo Clinic patients as part of their standard cancer care. The project, representing the largest known multicenter study of universal testing of patients with cancer, included a broad mix of cancer stages and types, including breast, colorectal, lung, ovarian, pancreatic, bladder, prostate and endometrial cancers.

The researchers were surprised to find that the standard guidelines physicians relied on to determine which patients with cancer should undergo genetic testing were only able to identify 48% of the patients with an inherited genetic mutation.

"More than half of the patients who developed cancer due to inherited mutations were being missed, and that has major implications for family members," Dr. Samadder says.

"Everyone has some risk of developing cancer, and in most cases the disease develops by chance. However, some people are genetically predisposed to developing certain types of cancer, such as breast or colon cancers." Dr. Samadder

During the study, when the researchers examined the effects of a genetic mutation discovery, they found that one-third of the patients with the highest-risk cancer genes had a change in their medical management, including the type of surgery or chemotherapy they received.

"This targeted treatment would have been lost if the patients had not received genetic testing," Dr. Samadder emphasizes.

"Genetic testing is underutilized in cancer care, both for patients and for their families, often due to outdated guidelines that restrict testing to a narrow group of high-risk patients," says Robert Nussbaum, M.D., chief medical officer of Invitae Corporation. "All cancer patients should have access to complete genetic information that can guide their care and inform their families' health." Dr. Nussbaum was a contributing author on the study.

Sharing genetic risks with family members

Dr. Samadder says equally important to the discovery of a patient's inherited cancer mutation is the potential for patients to share the heretible-cause of their disease with their relatives, allowing family members to pursue care for earlier disease detection and cancer management.

"We can help prevent cancer in their loved ones because it is genetic, and they share these cancer-causing genetic changes with their children, siblings and others in their families," Dr. Samadder explains. "We can target prevention strategies for those high-risk individuals and hopefully prevent cancer altogether in future generations of their family."

All blood-related family members of patients found to have a genetic mutation were offered free genetic testing. Overall, 1 in 5 of these family members underwent testing. The next steps will be to incorporate the study findings into the care of all patients with cancer at Mayo Clinic.

"Steps are being taken to ensure all patients are offered genomic sequencing to better understand the genes that led to the development of their cancer, and how to precisely target treatment and improve survival," Dr. Samadder says.

Genetic sequencing, deletion and duplication analysis, and variant interpretation was performed at Invitae Corporation in San Francisco. Support for this project was provided by the Mayo Transform the Practice Grant, Mayo Clinic's Center for Individualized Medicine, Desert Mountain Members' CARE Foundation, the David and Twila Woods Foundation, and a Faculty Career Development Award from the Gerstner Foundation (NJS).

Dr. Samadder presented his study at the American Society of Human Genetics on Oct. 30, 2020.

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Mayo Clinic study finds 1 in 8 patients with cancer harbor inherited genetic mutations - Greater Milwaukee Today

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COVID-19 is surging throughout the country, creating an opportunity for agile diagnostic businesses. This is how one newcomer is building an empire.

Elon Musk made news last week when the Tesla ((TSLA) -Get Report) founder claimed to test both positive and negative for the novel coronavirus, twice. Forty five weeks into the global pandemic and the United States still has a testing problem.

Fulgent Genetics ((FLGT) -Get Report), a smaller company with a $908 million market cap that most investors dont know, has a solution.

The problem, apart from the raging infection rates globally, is that not all tests are created equally.

Some, like the four given to Musk, are based on antigens. These so-called rapid tests look for viral proteins called antigens that are found in the surface of the virus. They also have the added benefitting of being inexpensive, at about $5 per test.

The gold standard is polymerase chain reaction variant. PCR tests detect viral genetic material through a process called amplification. They are far more accurate but can cost between $50 to $100 each. They also must be sent away to labs for diagnostics, creating delays of up to a week.

Given the costs and the absence of national testing protocols, businesses, state and local governments have veered toward rapid tests. The Food and Drug Administration, in July granted emergency approval for the use of six rapid tests. And in September the Trump administration began deploying 150 million of these tests across the country.

There is a big problem, though. Antigen tests can only detect proteins 5-7 days after the onset of symptoms. Researchers have determined that infectiousness may last up to 10 days. The result has been a lot of bad data and even greater spread of the virus.

In the week ended Nov. 7, the Center for Disease Control found COVID-19 positivity increased 8.4% week-over-week. A week later, the Washington Post reported that the number of new cases reached 167,276.

The solution seems to be a high quality but low cost PCR test with fast turnaround times.

Fulgent Genetics makes such a test. The company also the platform to deliver tests at scale.

The Temple City, Calif.-based company began in 2011 as a genetic testing platform. The founders worked with clinicians and patients to deliver reliable genetic tests for couples looking to become pregnant or for individuals susceptible to cancer or cardiovascular disease. A Fulgent test was a reliable way to learn about potential genetic risks at a reasonable cost.

The business changed course on March when the novel coronavirus started to impact Americans. Managers quickly leveraged the company diagnostic platform for COVID-19 testing. They hired new staff and built mobile labs in the company parking lot. They saw what the platform could become.

This was possible because the core technology was built from the ground up by engineers, not geneticists. They used parallel processing and machine learning artificial intelligence to process tests quickly and cost effectively. They built in extreme scalability.

Ming Hsieh, chief executive officer, last week spoke to that scale. During the third quarter financial results conference call Hsieh said that with only a modest investment in infrastructure, Fulgent was able to grow test volume by 5,000% year-over-year. During the same time frame gross margins improved by 19% sequentially. Quarterly profits doubled to $63.5 million.

In September the company contracted with New York public school system, the largest in the country. Fulgent will provide a self-administered, at home PCR test with results available within 24 hours. The deal follows another blockbuster deal in July for Los Angeles County for drive through PCR testing.

Its rare for a company of Fulgents size to be in the running for such contracts, let alone win them.

Musk said on Saturday said he would seek a PCR test after 4 antigen tests proved inconclusive.

Investors should expect this scenario to play out time and again as COVID-19 cases continue to expand. Fulgent is in the right place at the right time with the right product.

Shares trade at only 8.5x forward earnings and the market capitalization is still less than $1 billion. Given the sales leverage the stock could trade to $75 within 12 months, or 76% above current levels.

Investors should consider buying Fulgent into any material weakness.

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Small Covid Test Maker Is Going Viral - TheStreet

As a nationwide telehealth medical practice, Genome Medical has assembled an extensive team of clinical genetic experts, including board-certified genetic counselors, medical geneticists and other specialists. This team delivers education, risk assessment, access to genetic testing and specialty care referrals -- all through virtual visits. During the COVID-19 pandemic, when two out of five Americans have avoided or delayed medical care1, access to safe virtual services is essential to ensure people at greatest risk are receiving the care they need. Genetic services support the diagnosis and care management of hereditary conditions and the identification of patients at an elevated risk for disease.

Some of the largest payers in the United States are recognizing the critical role geneticists and genetic counselors play. Their members can now self-refer and get in-network access to Genome Medical's genetic experts, and the payer's contracted providers can also make in-network referrals for their patients.

The 90 million covered lives are across multiple payers, including (in part):

"Genome Medical brings together telemedicine and genomics to tackle the rising need for genetic experts to guide patients and providers in making appropriate decisions around 1) who should get genetic testing, 2) which test is optimal and 3) how clinical care should be changed based on test results," said Steven B. Bleyl, M.D., Ph.D., chief medical officer of Genome Medical. "Patients can be seen sooner, and through telehealth, we extend the reach of genetic services to rural communities and underserved areas that have less access to in-person care. Genome Medical is a flexible and cost-effective solution for payers and their members."

Genome Medical can see 85% of cancer patients more quickly than in a traditional clinic setting.2 And in areas like pediatric genetics, where wait times of six months or more for an appointment are common, Genome Medical's growing clinical team can often see patients within a few days. The company's genetic experts are licensed in all 50 states and provide clinical genetics expertise across six major specialty areas: cancer, reproductive health, proactive health, pediatrics/rare disease, pharmacogenomics and cardiovascular genetics. Genome Medical's innovative services are trusted and utilized by health systems, hospitals, testing labs, payors, providers and employers.

Genome Medical is also committed to leveraging advanced technology-enabled solutions to transform the delivery of standard-of-care genetic health services. Beyond wider and accelerated access, the company's technology delivers a 5.5X return on investment in genetic services, while also reducing the cost of care by up to 75 percent.3,4 Its Genome Care DeliveryTM platform creates an efficient and comprehensive experience, including patient engagement and care navigation, risk assessment, self-directed education and informed consent through the Genome Care NavigatorTM, multi-modality patient support, and peer-to-peer provider consultations.

"We are pleased to see health plan partners continue to expand in-network coverage for our genetic health services," said Lisa Alderson, co-founder and CEO of Genome Medical. "It is estimated that tens of millions of patients in the United States meet medical management guidelines for referral to genetics, but most are still being missed. These patients could benefit from the advancements made in utilizing genomics for prevention, diagnosis and treatment. Giving their members access to Genome Medical and telegenetics is a significant step payers are taking in removing historical barriers."

About Genome MedicalGenome Medical is a national telegenomics technology, services and strategy company bringing genomic medicine to everyday care. Through our nationwide network of genetic specialists and efficient Genome Care DeliveryTM technology platform, we provide expert virtual genetic care for individuals and their families to improve health and well-being. We also help health care providers and their patients navigate the rapidly expanding field of genetics and utilize test results to understand the risk for disease, accelerate disease diagnosis, make informed treatment decisions and lower the cost of care. We are shepherding in a new era of genomic medicine by creating easy, efficient access to top genetic experts. Genome Medical is headquartered in South San Francisco. To learn more, visit genomemedical.com and follow @GenomeMed.

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Genome Medical Reaches 90 Million Covered Lives in US - PRNewswire

In multiple solid malignancies, including breast, ovarian, colorectal, and pancreatic cancers, there is a subset of patients with a hereditary predisposition for these diseases, but the current testing criteria do not mention this subset. In an effort to provide more information of genetic testing in this population, a study of Memorial Sloan Kettering Cancer Center (MSKCC) patients was conducted to test the traditional guideline-based method of testing versus universal testing of a broad cancer patient population over a 5-year period.

A total of 7235 patients were included in the analysis and tested for 76 to 88 cancers. Through this study, investigators uncovered pathogenic and likely pathogenic (P/LP) variants in 7.5% (95% CI 6.6%- 8.4%) of 3,341 patients with breast cancer, 17.4% (95% CI, 14%- 21.6%) of 384 those with ovarian cancer, 13.5% (95% CI, 9.8%- 18%) of 252 patients with colorectal, and 8.8% (95% CI, 5.1%-14.8%) of 136 patients with pancreatic cancer.

Overall, the study found that testing with universal method was comparable to the guideline-based method, implying that universal testing can expand genetic testing to patient populations who are in need but are currently underserved.

In an interview with Targeted Oncology during the 2020 Association for Molecular Pathology (AMP) Annual Meeting, Ozge Ceyhan-Birsoy, PhD, assistant directorof the Laboratoryfor Molecular Medicine, MSKCC, discussed genetic testing methods for patients with hereditary predisposition and the molecular research underway at MSKCC to improve testing in this patient population.

TARGTED ONCOLOGY: In recent years, what advances have we see in cancer genetics?

Ceyhan-Birsoy: There have been significant advances in the range of genetic testing options for cancer patients in recent years. More patients are now able to receive molecular testing on their tumors to identify optimal targeted therapies for their cancer and germline genetic testing to uncover hereditary cancer predisposition. A paired analysis of tumor and normal DNA is increasingly being adapted, which improves the interpretation of both somatic and germline mutations. Additionally, incorporation of RNA analysis has expanded the scope of mutations that can be detected and characterized. Finally, the use of cell-free DNA now allows us to profile a patients tumor using only their blood.

TARGETED ONCOLOGY: How can hereditary predisposition inform oncologist for care/treatment decisions?

Ceyhan-Birsoy: Identifying hereditary mutations that predispose patients to cancer has important implications for their treatment and management. There are established targeted therapies available now for certain germline defects. For instance, germline mutations in certain homologous recombination and mismatch repair genes can predict response to PARP inhibitor and immune-checkpoint inhibitor therapies, respectively. Some therapies may pose high risk for patients with particular gene mutations, such as radiation therapy risks for patients with germline TP53 mutations. In addition, identifying hereditary cancer predisposition is critical to allow timely surveillance and prophylactic interventions for future cancers that the patient may be at higher risk of developing. As germline mutations are heritable, this information provides the opportunity for early surveillance in the patients family members, as well.

TARGETED ONCOLOGY: Can you explain how this MSKCC study came about?

Ceyhan-Birsoy: Genetic testing for hereditary cancer predisposition is traditionally performed in a guideline-dependent and targeted manner. In current practice, only patients who meet established criteria from national and professional organizations receive genetic testing and typically get tested for a small number of genes selected based on their tumor type, age of onset, and family histories. MSKCC has been 1 of the first institutes to pilot a universal testing approach for cancer patients, providing comprehensive germline testing of all known cancer predisposition genes without pre-selection of patients based on traditional genetic testing criteria. We have been performing both targeted and universal testing for our patients since 2015.

In this study, we aimed to understand how the yields (positive rates) of these 2 testing approaches compare to each other in greater than 4000 patients who had traditional and more than 9,000 patients who had universal testing at MSKCC in the past 5 years. We also assessed whether universal testing identified additional findings that would have been missed in a targeted testing approach for any given patient.

TARGETED ONCOLOGY: What are the key results of this analysis?

Ceyhan-Birsoy: We saw that universal germline testing without preselection of patients based on current guidelines yielded comparable rates of positive results to traditional guideline-dependent testing approach, particularly in patients with breast, ovarian, and pancreatic cancers. In addition, universal testing uncovered mutations that predispose to other cancers in about 9% of patients in genes that are not routinely tested for their diagnosis. Approximately half of those conferred high to moderate risk to cancer and about 40% of them implicated early surveillance or prophylactic surgery recommendations to prevent other cancers.

TARGETED ONCOLOGY: What is a key takeaway from your AMP 2020 presentation and explain the implications of these findings?

Ceyhan-Birsoy: Our results suggest that the preselection of patients for genetic testing based on the current guidelines may not significantly increase the likelihood of identifying a germline mutation in certain patient populations. A universal and comprehensive testing approach further provides the benefit of identifying hereditary risk for other cancers, allowing early surveillance and prophylactic interventions.

TARGETED ONCOLOGY: How can this information be applied in oncology clinics?

Ceyhan-Birsoy: Our study underlies the advantages of universal and comprehensive testing for cancer patients. However, there are many challenges that may limit the application of this approach for all cancer patients, including the cost of testing, resources needed to provide pre-test and post-test genetic counseling to patients, and the potential to discover more variants of uncertain significance that may lead to higher number of inconclusive results. Future efforts should be dedicated to providing wider groups of cancer patients access to genetic testing, which can aid in their clinical care and in the care of their family members.

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Molecular Testing With Universal Method Comparable to Traditional Method in Hereditary Solid Tumors - Targeted Oncology

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List Of Key Players

Helix23andMePathway GenomicsLaboratory Corporation of AmericaThermo FisherWeGeneMapMyGenomeGene by GeneAfrican AncestryColor GenomicsMyriad GeneticsQuest Diagnostics

DTC Genetic Testing Market Segmentation: By Types

Disease Risk and HealthAncestry or GenealogyKinshipLifestyle

DTC Genetic Testing Market Segmentation: By Applications

On-line SalesDoctors Office

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Regional Market(Production, Demand, Trade) Analysis

Global Market Key Manufacturers Analysis

Global DTC Genetic Testing Market Consumption and Growth Rate Analysis and Forecast (2018-2023)

Global DTC Genetic Testing Market Status and SWOT Analysis by Regions

Global DTC Genetic Testing Market Analysis and Forecast by Type and Application

Global DTC Genetic Testing Market Analysis and Forecast by regions

Global DTC Genetic Testing Industry Barriers, Suggestions and SWOT and Feasibility Analysis

Appendix, Research Finding, Assumptions, and Conclusion

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Global DTC Genetic Testing Market 2020 Comprehensive analysis with Top Manufacturers, Trends, Share, Future Growth Opportunities & Forecast by...

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Top leading companies are

Thermo Fisher Scientific, Inc., Agilent Technologies, Inc., PerkinElmer, Inc., CooperSurgical, Inc., Beijing Genomics Institute (BGI), Abbott Laboratories, Natera, Inc., Genea Limited, Rubicon Genomics, Inc. and Oxford Gene Technology

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Preimplantation Genetic Testing Market Segmentation

Market by Type

by Test Type (Aneuploidy, Structural Chromosomal Abnormalities, Single Gene Disorders, X-linked Disorders, HLA Typing, Gender Identification) and Technology (Next Generation Sequencing, Polymerase Chain Reaction, Fluorescent In-Situ Hybridization, Comparative Genomic Hybridization, Single Nucleotide Polymorphism)

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Top key players includes:

Thermo Fisher Scientific, Inc., Agilent Technologies, Inc., PerkinElmer, Inc., CooperSurgical, Inc., Beijing Genomics Institute (BGI), Abbott Laboratories, Natera, Inc., Genea Limited, Rubicon Genomics, Inc. and Oxford Gene Technology

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Market Segmentation

Market by Type

by Test Type (Aneuploidy, Structural Chromosomal Abnormalities, Single Gene Disorders, X-linked Disorders, HLA Typing, Gender Identification) and Technology (Next Generation Sequencing, Polymerase Chain Reaction, Fluorescent In-Situ Hybridization, Comparative Genomic Hybridization, Single Nucleotide Polymorphism)

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The study covers the production, sales, and revenue of various top players in the global Preimplantation Genetic Testing market, therefore enabling customers to achieve thorough information of the competition and henceforth plan accordingly to challenge them head on and grasp the maximum market share. This report is filled with significant statistics and information for the consumers to attain in-depth data of the Preimplantation Genetic Testing and further Preimplantation Genetic Testing growth. The up-to-date, complete product knowledge, end users, industry growth will drive the profitability and revenue. Preimplantation Genetic Testing report studies the current state of the market to analyze the future opportunities and risks. Preimplantation Genetic Testing report provides a 360-degree global market state. Primarily, the report delivers Preimplantation Genetic Testing introduction, overview, market objectives, market definition, scope, and market size valuation.

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Preimplantation Genetic Testing Market Outlook and Opportunities in Grooming Regions with Forecast to 2027 - The Daily Philadelphian

Genetic Testing market report studies overview of market drivers, constraints, challenges and opportunities. It predicts the growth rate of the global Genetic Testing market in between the forecasted period. This research report covers the dynamics of the global Genetic Testing market with a thorough overview of the overall market growth prospects. Genetic Testing market report contain overall market size, share and growth prospect of industry.

About Genetic Testing Market:

Genetic Testing Market analysis considers sales from both equipment and consumable products. Our study also finds the sales of genetic testing in Asia, Europe, North America, and ROW. In 2019, the equipment segment had a significant market share, and this trend is expected to continue over the forecast period. Factors such as increasing workload for performing high-throughput tests in clinical diagnostic facilities will play a significant role in the equipment segment to maintain its market position. Also, our global genetic testing market report looks at factors such as rising prevalence of genetic diseases and disorders, rising approval of advanced genetic testing products, and increasing affordability due to reduction in cost of genetic testing. However, varying regulations on genetic testing and research globally, issues related to product recalls, and lack of trained genetic professionals may hamper the growth of the genetic testing industry over the forecast period.

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Market Dynamics of Genetic Testing Market:

Driver: Rising Approval Of Advanced Genetic Testing Products

Trends: Growing Adoption Of Pharmacogenetic Testing In Reducing Adverse Drug Events

Challenges: Lack Of Trained Genetic Professionals

Rising approval of advanced genetic testing products

Commercial applications of genetic screening in human health management and the advent of whole genome sequencing have allowed vendors to offer a variety of innovative products in the global genetic testing market. The use of advanced technologies such as pharmacogenomics and companion diagnostics has helped vendors in assuring the safety of their products. Furthermore, the deployment of rapid and simplified technologies in genetic testing offers several benefits including the reduction in turnaround time, optimum resource use, and accuracy in genetic diagnosis. Thus, the rising approval of advanced genetic testing products will lead to the expansion of the global genetic testing market at a CAGR of over 12% during the forecast period.

Growing adoption of pharmacogenetic testing in reducing adverse drug events

The growing approval of new drug molecules and the rising demand for targeted therapies and personalized medicines have increased the adoption of pharmacogenomic testing by pharmaceutical companies. Pharmacogenomic testing combines the principles of pharmacology and genomics to study the response of an individual to any specific drug. The study of drug-specific responses allows pharmaceutical companies to prevent adverse drug incidence and ensure drug safety and performance during pre and post commercial stages. This development is expected to have a positive impact on the overall market growth.

Some Key Players of Genetic Testing Market Are:

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Genetic Testing Market Segmentation Analysis:

By Type:

Genetic Testing Market Report Highlights:

Genetic Testing Market Segment by Regions:

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Some Points from Genetic Testing Market Report TOC:

PART01:EXECUTIVESUMMARY

PART02:SCOPEOFTHEREPORT

PART03:MARKETLANDSCAPE

PART04:MARKETSIZING

PART05:FIVEFORCESANALYSIS

PART06:MARKETSEGMENTATIONBYTECHNOLOGY

PART07:MARKETSEGMENTATIONBYFURNACETYPE

PART08:CUSTOMERLANDSCAPE

PART09:GEOGRAPHICLANDSCAPE

PART 10: DRIVERS AND CHALLENGES

PART 11: MARKET TRENDS

PART 12: VENDOR LANDSCAPE

PART 13: VENDOR ANALYSIS

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Genetic Testing Market by Size, Covid-19 Impact, Competitive Strategy, Worldwide Growth Insights, Regional Trends, Segmentation and Forecast to 2024 -...

The Direct-to-Consumer Genetic Testing Devices Market is expected to have a highly positive outlook for the next five years 2020-2026. This Research report emphasizes on key industry analysis, market size, share, growth, and extensive industry dynamics with respect to with respect to drivers, opportunities, pricing details, and latest trends in the industry.

The global Direct-to-Consumer Genetic Testing Devices market analysis further provides pioneering landscape of market along with market augmentation history and key development involved in the industry. The report also features a comprehensive research study for high growth potential industries professional survey with market analysis. Direct-to-Consumer Genetic Testing Devices market report helps the companies to understand the market trends and future market prospective, opportunities and articulate the critical business strategies.

Request A Sample Copy Direct-to-Consumer Genetic Testing Devices Market Report Click here: https://www.coherentmarketinsights.com/insight/request-sample/1046

Geographical segmentation of Direct-to-Consumer Genetic Testing Devices Market involves the regional outlook which further covers United States, China, Europe, Japan, Southeast Asia, and Middle East & Africa. This report categorizes the market based on manufacturers, regions, type, and application.

Direct-to-Consumer Genetic Testing Devices Market: Competitive Landscape

Leading players operating in the global Direct-to-Consumer Genetic Testing Devices market includePathway Genomics, Color Genomics, Counsyl, Inc., deCode genetics, Inc., Map My Gene, and GenePartner.

Scope of the Report

The key features of the Direct-to-Consumer Genetic Testing Devices Market report 2020-2026 are the organization, extensive amount of analysis, and data from previous and current years as well as forecast data for the next five years. Most of the report is made up from tables, charts and figures that give our clients a clear picture of the Direct-to-Consumer Genetic Testing Devices Market. The structure of keyword Market by identifying its various segments and sub-segments to help understanding the report.

keyword Market Research Report gives current competitive analysis and also valuable insights to clients/industries, which will assist them to prepare a new strategy to expand or penetrate in a global keyword market.

As the report proceeds further, it covers the analysis of key market participants paired with development plans and policies, production techniques, price structure of the Direct-to-Consumer Genetic Testing Devices market. The report also identifies the other essential elements such as product overview, supply chain relationship, raw material supply and demand statistics, expected developments, profit and consumption ratio.

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Important Direct-to-Consumer Genetic Testing Devices Market Data Available In This Report:

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Covid 19 Analysis On Direct-to-Consumer Genetic Testing Devices Market Growth in Business Future Scenarios and Brief Analysis of Top Key Players |...

SALT LAKE CITY, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, announced today the expansion of Myriad myChoice tumor testing in several European markets and China.

Myriad myChoice CDx is the industrys most clinically-validated genomic instability test. The test enables physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in potentially increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors, including Lynparza (olaparib). A biomarker subgroup analysis of the PAOLA-1 Phase III trial (Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer, 2019) of Lynparza included patients with advanced ovarian cancer and homologous recombination deficient (HRD)-positive tumors as detected by the myChoice test, including those with BRCA gene mutations. The trial showed that Lynparza in combination with bevacizumab maintenance treatment improved progression-free survival to a median of 37.2 months versus 17.7 months for bevacizumab alone in patients with HRD-positive advanced ovarian cancer. Recently, the European Commission authorized use of Lynparza for the first-line maintenance treatment with bevacizumab of patients with HRD-positive advanced ovarian cancer. Lynparza is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and Merck.

As part of the expansion in Europe, Myriad will license and provide technological support to leading pathology institutes in Germany and France. Additionally, Myriad will support European customers by performing testing out of its clinical laboratory at the companys global headquarters in Salt Lake City. Also, the institutes in Europe will perform the tests with Myriads myChoice CDx PLUS assay. Myriad myChoice CDx PLUS is CE-marked in accordance with the In-Vitro Diagnostic Devices Directive (98/79/EC).

Another collaboration in China provides that Myriad will partner with Burning Rock Biotech, a leader in next generation sequencing technology for precision oncology, to provide myChoice for HRD testing in Phase III clinical studies and clinics throughout China. Myriad will provide Burning Rock with access to its proprietary myChoice technology. The partnership with Burning Rock expands global access to myChoice and positions the test as a preferred developmental companion diagnostic in this important drug development category.

These new strategic partnerships with leading companies dedicated to advancing the power of precision medicine, reinforce Myriads commitment to expanding access to genetic insights for more patients than ever before, said Nicole Lambert, president of Myriad Genetic Laboratories. Through close collaboration with innovative laboratories in Europe and with Burning Rock in China, we are bringing the clinical benefits of myChoice testing to additional markets and patients, advancing personalized treatment for patients around the world.

In August 2020, myChoice was exclusively cited and the only named commercial companion diagnostic by the American Society of Clinical Oncology in new recommendations on the use of PARP inhibitors for the treatment and management of certain patients with advanced ovarian cancer. The new recommendations, based on clinical trial results, were published in the Journal of Clinical Oncology.

AboutMyriad myChoice Myriad myChoice is the most comprehensive homologous recombination deficiency (HRD) test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions). For more information, visit: https://myriad-oncology.com/mychoice-cdx/

About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website:www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Companys new international collaborations on the myChoice CDx test, including offering the test to European patients, and partnering with pathology institutes in Europe and Burning Rock in China; and the Companys strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Media Contact: Jared Maxwell (801) 505-5027 jmaxwell@myriad.comInvestor Contact: Scott Gleason(801) 584-1143sgleason@myriad.com

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Myriad Genetics Announces Global Expansion of Myriad myChoice Tumor Testing in Europe and China - GlobeNewswire

PHILADELPHIA, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, and Invitae (NYSE: NVTA), a leading medical genetics company, announce a collaboration to facilitate genetic testing and support early identification of GM1 gangliosidosis (GM1) through Invitaes Detect Lysosomal Storage Disorders (Detect LSDs). The two companies also are partnering to provide educational clinical trial information to clinicians and patients.

Early identification and intervention are crucial steps in providing effective treatment to patients with GM1, particularly in the infantile form where onset occurs within the first six months of a patients life, said Bruce Goldsmith, Ph.D, president and chief executive officer of Passage Bio. By combining Invitaes no-charge testing and counseling with information on clinical trials, clinicians will be able to intervene sooner and more efficiently, shortening the timeline to reliable diagnosis. As we plan to initiate our Phase 1/2 trial for PBGM01 soon, this partnership will be an important part of our support for patients and will also serve as a key resource to patients with GM1 and their families.

The Detect LSDs program offers genetic testing and genetic counseling at no charge to patients to encourage earlier diagnosis of lysosomal storage disorders like GM1 and, as a result, earlier access to clinical trials. In addition, Invitae provides clinical trial information and education to clinicians and patients who may benefit. Currently, the Detect LSDs program is available to patients within the United States and Canada.

Increasing access to genetic testing supports earlier diagnosis, enables clinical trials to develop new treatments and helps clinicians provide precision therapies sooner for better overall outcomes, said Robert Nussbaum, M.D., chief medical officer of Invitae. Were pleased Passage Bio has joined us in this effort.

Additional details, as well as terms and conditions of the Detect LSDs program, can be found at https://www.invitae.com/en/detectLSDs/.

About GM1

GM1 gangliosidosis (GM1) is a rare and often life-threatening monogenic recessive lysosomal storage disease caused by mutations in the GLB1 gene, which encodes lysosomal acid beta-galactosidase (-gal). Reduced -gal activity results in the accumulation of toxic levels of GM1 ganglioside in neurons throughout the brain, causing rapidly progressing neurodegeneration. GM1 manifests as a continuum of disease and is most severe in the Infantile form, which is characterized by onset in the first 6 months of life with hypotonia (reduced muscle tone), progressive CNS dysfunction, and rapid developmental regression. Life expectancy for infants with GM1 is two to four years, and infantile GM1 represents approximately 62.5% of the incidence of 0.5 to 1 in 100,000 live births. Currently, there are no approved disease-modifying therapies available.

About Passage Bio

At Passage Bio (Nasdaq: PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvanias Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. This provides our team with unparalleled access to a broad portfolio of gene therapy candidates and future gene therapy innovations that we then pair with our deep clinical, regulatory, manufacturing and commercial expertise to rapidly advance our robust pipeline of optimized gene therapies into clinical testing. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies. More information is available at http://www.passagebio.com.

About Invitae

Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website atinvitae.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995, including, but not limited to: our expectations about timing and execution of anticipated milestones, including our planned IND submissions, initiation of clinical trials and the availability of clinical data from such trials; our expectations about our collaborators and partners ability to execute key initiatives; our expectations about manufacturing plans and strategies; our expectations about cash runway; and the ability of our lead product candidates to treat the underlying causes of their respective target monogenic CNS disorders. These forward-looking statements may be accompanied by such words as aim, anticipate, believe, could, estimate, expect, forecast, goal, intend, may, might, plan, potential, possible, will, would, and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop and obtain regulatory approval for our product candidates; the timing and results of preclinical studies and clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; failure to protect and enforce our intellectual property, and other proprietary rights; our dependence on collaborators and other third parties for the development and manufacture of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions caused by the coronavirus pandemic; and the other risks and uncertainties that are described in the Risk Factors section in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Passage Bio undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

For further information, please contact:

Investors:Sarah McCabe and Zofia MitaStern Investor Relations, Inc.sarah.mccabe@sternir.com and zofia.mita@sternir.com

Media:Media:Gwen FisherPassage Bio215-407-1548gfisher@passagebio.com

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Passage Bio and Invitae Announce Collaboration to Facilitate Genetic Testing to Support Early Diagnosis and Greater Awareness of Clinical Trials for...

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 Rare Disease Genetic Testing market.

Trusted Business Insights presents an updated and Latest Study on Rare Disease Genetic Testing Market 2020-2029. 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 Rare Disease Genetic Testing market during the forecast period (2020-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Rare Disease Genetic Testing Market 2020 and Forecast 2021-2027 Includes Business Impact Analysis of COVID-19

Report Overview: Rare Disease Genetic Testing Market

The global rare disease genetic testing market size was valued at USD 690.1 million in 2020 and is projected to register a Compound Annual Growth Rate (CAGR) of 8.8% from 2021 to 2027. Misdiagnosis can result in interventions that could later be considered inappropriate for the underlying disorder. Thus, the need for an accurate and timely diagnosis for rare conditions drives the demand for genetic testing. Currently, the lack of awareness pertaining to these conditions is one of the primary challenges for the market. Thus, several efforts are being undertaken to help raise awareness about various aspects of rare and ultra-rare diseases, such as the challenges pertaining to diagnosis and clinical implementation of available diagnostic approaches.

Companies like Shire Plc are engaged in supporting domestic diagnostic testing for rare disorders in certain countries and offer learning programs for healthcare experts on genetic testing. Every country has developed its registry for rare diseases that acts as a focal point of information on these conditions. Patient registries and databases play a integral role in clinical research in the field of rare diseases and help in improving healthcare planning and patient care.

A rise in the number of available registries is one of the major driving factors of the market as it enables pool data to achieve a sufficient sample size for epidemiological and/or clinical research. Furthermore, technological advancements in data collection and interpretation for clinical practice has driven the market. Companies are making efforts to ensure efficient data collection from various ethnicities, which is expected to aid in the diagnosis of thousands of patients with the same condition.

In addition, companies, such as Centogene, combine genetic testing with metabolomics and proteomics to make their data analysis process as accurate as possible. The multi-omics approach helps better understand the impact of a given mutation on the protein as well as at the metabolite level. The company has also introduced a system to simplify the sample collection process, thereby driving the adoption of genetic tests for rare disease diagnosis.

Disease Type Insights: Rare Disease Genetic Testing Market

Neurological disorders segment accounted for the largest share of 12.9% in 2019. A substantial number of commercially-approved genetic tests for neurologic conditions coupled with a high prevalence of neurological diseases has accelerated the revenue growth in this segment. Tests offered by companies are recommended by several medical institutes, such as the American Academy of Neurology, American College of Medical Genetics, and Child Neurology Society.

Furthermore, the advent of high-throughput techniques, such as exome sequencing and whole-genome sequencing, has offered lucrative opportunities for companies offering tests for diseases, such as X-ALD. Exome sequencing and whole-genome sequencing have helped in addressing complicated cases of X-ALD that present an atypical disease course.

Moreover, immunologic disorders, such as Multiple Sclerosis (MS), are among the most prevalent rare diseases. The genetic profile of MS is one of the key focus areas among researchers in this field. This is primarily to obtain relevant insights pertaining to the causes and underlying physiology of diseases, resulting in a significant share of this segment.

End-use Insights: Rare Disease Genetic Testing Market

Research laboratories & CROs captured the maximum share of 46.9% of the market in 2019. This is primarily because in a substantial number of cases, blood samples collected from patients are sent to a laboratory for testing. Laboratories offer testing based on various specialties, including molecular, chromosomal, and biochemical genetic tests. For instance, ARUP Laboratories offers testing in molecular genetics, cytogenetics, genomic microarray, and biochemical genetics.

Laboratories also offer genetic counseling services that further accelerate the uptake of services among patients. Moreover, molecular genetic testing-based laboratory testing is rapidly increasing worldwide. Genetic tests are conducted by multiple laboratories, including those that are accredited with CLIA for clinical cytogenetics, pathology, and chemistry, among other specialties. These companies are involved in expanding their test portfolio by undertaking various strategic initiatives.

For instance, in January 2020, Quest Diagnostics acquired Blueprint Genetics to enhance its expertise in genetic disorders and rare diseases. Furthermore, in June 2018, Centogene launched its diagnostic laboratory in Cambridge, Massachusetts. Such initiatives depict the growing interest of diagnostic centers in genetic testing of rare diseases, which is likely to boost segment growth.

Technology Insights: Rare Disease Genetic Testing Market

Next Generation Sequencing (NGS) accounted for the largest share of 36.6% in 2019 owing to the high usage of Whole Exome Sequencing (WES). WES is being considered a highly potential method in a case where the genetic cause of disease is unknown and is difficult to identify. WES is becoming the standard of care for patients with undiagnosed rare diseases. This is attributed to the fact that exons make up around 1.5% of an individuals genome and contain 85% of all known disease-causing mutations.

Moreover, with the declining costs of WES, the cost of genetic testing is also anticipated to reduce significantly, making the test more affordable and accessible. In addition, medical coverage for WES-based genetic tests has favored segment growth. A substantial number of private health insurance agencies cover all or part of the cost of genetic testing, post recommendation by a healthcare professional. As compared to WES, clinical Whole Genome Sequencing (WGS) has lesser demand.

However, with a continuous decrease in cost, adoption of WGS is expected to amplify. For instance, the Rady Childrens Institute for Genomic Medicine offers singleton-rapid WGS and a trio-rapid WGS at a reasonable cost. In February 2020, Dante Labs launched an initiative to offer WGS to patients with rare diseases for USD 299. The service included WGS 30X on Novaseq6000 technology, data interpretation, and personalized therapy on these diseases.

Specialty Insights: Rare Disease Genetic Testing Market

Accounting for more than 40% revenue share, molecular genetic tests led the market in 2019. Rapid technological advancements and expertise in handling & managing high throughput technologies within clinical settings have driven the revenue in this segment. Molecular genetic test methods enable investigating single genes or short lengths of DNA for the detection of mutations or variations leading to genetic disorders.

Apart from rare diseases, the method also covers testing of ultra-rare diseases, which will augment the segment growth in future. Biochemical genetic tests are expected to register the second-fastest CAGR during the forecast period owing to their efficiency to assess the activity and amount of proteins & related abnormalities for the identification of changes in the DNA that can cause a metabolic disorder.

Also, the companies are expanding their test portfolio to capitalize on the potential opportunities present in this segment. In September 2019, Blueprint Genetics collaborated with ARCHIMEDlife to launch high-quality biochemical tests for rare diseases. Such developments are anticipated to boost the revenue share of the segment in the coming years.

Regional Insights: Rare Disease Genetic Testing Market

North America accounted for the largest market share of over 47% in 2019. Factors, such as high incidence of rare disorders, a large number of rare disorders registries, and the presence of substantial numbers of R&D facilities for rare & ultra-rare diseases, and extensive investments in the diagnosis of rare disorders in the region drives the market growth. As per the National Institutes of Health (NIH), around 30 million Americans have been identified with one of 7,000+ known rare diseases. Moreover, the number of patients undergoing disease testing is expected to increase in the coming years, thereby supporting market growth.

Asia Pacific is expected to register the fastest CAGR from 2020 to 2027 due to rising awareness and target population in Asian countries. China is attempting to shift the attention of the healthcare system towards the diagnosis and treatment of rare disorders. The government in the country has included rare disease management as a public health priority in its 2030 roadmap titledHealthy China 2030. Furthermore, in June 2018, the country released its first list of rare disorders to enable the patients to find solutions effectively at their local hospitals.

Key Companies & Market Share Insights: Rare Disease Genetic Testing Market

The development of technologies, such as WES & WGS, has significantly transformed genetic testing space by offering convenient and cost-effective methods that can be conducted for a wide range of conditions across multiple clinical settings. As a result, major diagnostic companies are engaged in expanding their product portfolio that can be used to conduct tests for rare and ultra-rare conditions.

In addition, they have undertaken various initiatives, such as mergers & acquisitions, to expand their offerings and subsequently strengthen their presence in this market. For example, the acquisition of GeneDX by OPKO. The acquisition helped the latter company to expand its business in the market. Similarly, Quest strengthened its presence in the market with the acquisition of Blueprint Genetics. Another important acquisition in the market is Qiagens acquisition by Thermo Fisher.

The companies have signed an agreement in March 2020; however, it is targeted to be completed by the first quarter of 2021, as ThermoFisher Scientific is lining up finances for the USD 11.5 billion deal, with an offering worth $2.2 billion. This deal is expected to impact the life science tools and reagents market significantly. With regard to rare disorder genetic testing, Thermo Fisher Scientific is engaged in research and provides sequencing for the Osteogenesis imperfecta and Vascular Ehlers-Danlos syndrome. Some of the prominent players in the rare disease genetic testing market include:

Key companies Profiled: Rare Disease Genetic Testing Market Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub segments from 2016 to 2027. For the purpose of this study, Trusted Business Insights has segmented the global rare disease genetic testing market report on the basis of disease type, technology, specialty, end use, and region:

Disease Type Outlook (Revenue, USD Million, 2016 2027)

Technology Outlook (Revenue, USD Million, 2016 2027)

Specialty Outlook (Revenue, USD Million, 2016 2027)

End-use Outlook (Revenue, USD Million, 2016 2027)

Looking for more? Check out our repository for all available reports on Rare Disease Genetic Testing in related sectors.

Quick Read Table of Contents of this Report @ Rare Disease Genetic Testing Market 2020 and Forecast 2021-2027 Includes Business Impact Analysis of COVID-19

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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Rare Disease Genetic Testing Market Analysis, COVID-19 Impact,Outlook, Opportunities, Size, Share Forecast and Supply Demand 2021-2027|Trusted...

When discussing a diagnosis of epilepsy, advances in genetic testing are proving that it is indeed all about the details. Comprehensive genetic testing is making it possible to drill down into those details. When testing is based on whole genome sequencing (WGS) technology, it is possible to identify genetic changes, or variants, in the 370-plus seizure-associated genes found amongst the 20,000 or so genes within the human genome or, more importantly, the large number of variants located within or spanning those genes. A single-method approach for detecting multiple variant types from a single patient sample can more accurately lead to a diagnosis, resulting in more-tailored medical management and providing a better basis for improved long-term outcomes and family planning.

In the United States, epilepsy is the fourth most common neurological condition, surpassed only by migraine, stroke, and Alzheimers disease. Each year, 150,000 people on average will develop epilepsy (48 out of 100,000) and its prevalence is currently estimated at around 2.2 million people (or 7.1 out of every 1,000 people). Epilepsy is a spectrum condition characterized by unpredictable seizures that can cause or co-occur with other health problems. There is a wide range of seizure types and the ability to control them varies from person-to-person, even within families. The cause of epilepsy is often unknown, but it is most often related to brain injury or genetics. However, the word epilepsy itself has nothing to do with the cause, severity, or type(s) of an individuals seizures.

Genetic seizure disorders span multiple classes. They can include specific syndromes in which a seizure is the only symptom as well as occur as part of broader neurodevelopmental conditions that present with additional features, such as intellectual disability. Seizures may also be present as a symptom of metabolic conditions and/or other disorders. Seizure disorders share symptoms (phenotypes) with many other conditions, which often make it difficult to determine the inheritance pattern from the family history. Causal variants may be inherited from a parent or simply show up new (de novo) in a persons DNA. In some cases, variants in multiple genes may together contribute to the clinical symptoms. Many different types of variants have been shown to cause seizure disorders.

This is why definitively diagnosing the genetic cause of epilepsy can be challenging. Traditionally, this is accomplished through multiple, sequential tests. This step-wise method typically begins with what is known as a chromosomal microarray, which involves structural analysis of a persons chromosomes and checks to make sure there are no large imbalances (extra or missing pieces) that could cause epilepsy. If the microarray does not reveal a positive result, the next step is usually single-gene or multi-gene panel testing, depending on the specific nature of the individuals symptoms. If no causal variant is identified with those tests, the final step is exome testing, if the patients insurance allows for multiple genetic tests. This results in a long process of repeated rounds of testing, with each individual round limited by the types of variants that can be detected, leaving gaps in variant coverage and detection, and therefore leaving gaps in the ability to properly diagnose a patient. That is because, as a general rule, microarray, panel, and exome tests individually do not perform well at detecting a broad spectrum of changes (variants) in genetic material.

Comprehensive testing based on WGS technology has the ability to detect a wide range of variant types not covered by traditional microarray, panel-based, or exome tests, as well as the ability to reanalyze patient data in the future without resequencing. Combining WGSs consistent, comprehensive sequence coverage with proprietary algorithms allows for the detection of variants without any size limitations. The result is more-comprehensive testing of the entire spectrum of variants and genes associated with genetic epilepsy. All of this is accomplished with a single blood draw (or saliva sample) and a turnaround time of six to eight weeks.

The ability to quickly establish a genetic cause of epilepsy utilizing WGS can provide the information necessary to control an individuals seizures as soon as possible. The longer a patient experiences uncontrolled seizures, the more likely they will suffer irreparable damage to the brain. Depending on their frequency and length, uncontrolled seizures can interfere with daily activities and can negatively impact someones quality of life. The sooner that clinicians can identify an individuals cause of seizures and treat it appropriately, the better the prognosis for the long-term management of disease.

Above: Image of aa sample collection kit from Variantyx.

In some cases, a genetic diagnosis may help guide the selection ofanti-seizure medications, as there are some well-known links between certain medications and specific genetic epilepsy disorders. Some medicines work better while others may cause adverse side-effects, all of which can be determined by pinpointing of the variant causing the disease. Comprehensive genetic testing may also bring to light the risk of epilepsy to other family members, including the risk of passing the disorder on to a child. A genetic diagnosis can also assist individuals and families in finding and accessing the proper resources, from advocacy groups to connections with families sharing in similar struggles, and in opening up the door to participation in clinical studies for individuals with a related genetic diagnosis.

In summary, a single-method approach for the detection of a genetic cause of epilepsy is achievable by identifying multiple-variant types from a single patient sample through WGS technology. The result is a cost-effective, comprehensive analysis of an individuals DNA summarized in a single, unified clinical report. Obtaining a genetic diagnosis through WGS may end what is often referred to as the diagnostic odyssey or the search for an answer by an individual or family as well as provide information to guide treatment and maximize a patients quality of life.

Link:
The Value of a Molecular Diagnosis of Epilepsy - Medical Device and Diagnostics Industry

Market Overview of Pre-Pregnancy Genetic Testing Market

The Pre-Pregnancy Genetic Testing market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.

The global Pre-Pregnancy Genetic Testing market size is expected to gain market growth in the forecast period of 2020 to 2025, with a CAGR of xx%% in the forecast period of 2020 to 2025 and will expected to reach USD xx million by 2025, from USD xx million in 2019.

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Market segmentation

Pre-Pregnancy Genetic Testing market is split by Type and by Application. For the period 2015-2025, the growth among segments provide accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.

segment by Type, the product can be split intoChorionic Villi Sampling (CVS)AmniocentesisPlacental BiopsyCordocentesisFetal Biopsy

Market segment by Application, split intoHospitalsClinicsDiagnostic CentersOther

Based on regional and country-level analysis, the Pre-Pregnancy Genetic Testing market has been segmented as follows:North AmericaUnited StatesCanadaEuropeGermanyFranceU.K.ItalyRussiaNordicRest of EuropeAsia-PacificChinaJapanSouth KoreaSoutheast AsiaIndiaAustraliaRest of Asia-PacificLatin AmericaMexicoBrazilMiddle East & AfricaTurkeySaudi ArabiaUAERest of Middle East & Africa

Regional analysis is another highly comprehensive part of the research and analysis study of the global Pre-Pregnancy Genetic Testing market presented in the report. This section sheds light on the sales growth of different regional and country-level Pre-Pregnancy Genetic Testing markets. For the historical and forecast period 2015 to 2025, it provides detailed and accurate country-wise volume analysis and region-wise market size analysis of the global Pre-Pregnancy Genetic Testing market.

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The report offers in-depth assessment of the growth and other aspects of the Pre-Pregnancy Genetic Testing market in important countries (regions), including:

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, etc.)

Middle East & Africa (Saudi Arabia, Egypt, Nigeria and South Africa)

Pre-Pregnancy Genetic Testing competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, Pre-Pregnancy Genetic Testing sales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2015-2020, this study provides the Pre-Pregnancy Genetic Testing sales, revenue and market share for each player covered in this report.

In the competitive analysis section of the report, leading as well as prominent players of the global Pre-Pregnancy Genetic Testing market are broadly studied on the basis of key factors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on price and revenue (global level) by player for the period 2015-2020.The key players covered in this studySequenom Laboratories (US)Illumina (US)Natera (US)Ariosa Diagnostics (US)BGI Health (China)LifeCodexx (Germany)Counsyl (US)

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The content of the study subjects, includes a total of 15 chapters:

Chapter 1, to describe Pre-Pregnancy Genetic Testing product scope, market overview, market opportunities, market driving force and market risks.

Chapter 2, to profile the top manufacturers of Pre-Pregnancy Genetic Testing , with price, sales, revenue and global market share of Pre-Pregnancy Genetic Testing in 2018 and 2019.

Chapter 3, the Pre-Pregnancy Genetic Testing competitive situation, sales, revenue and global market share of top manufacturers are analyzed emphatically by landscape contrast.

Chapter 4, the Pre-Pregnancy Genetic Testing breakdown data are shown at the regional level, to show the sales, revenue and growth by regions, from 2015 to 2020.

Chapter 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue and market share for key countries in the world, from 2015 to 2020.

Chapter 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2015 to 2020.

Chapter 12, Pre-Pregnancy Genetic Testing market forecast, by regions, type and application, with sales and revenue, from 2020 to 2025.

Chapter 13, 14 and 15, to describe Pre-Pregnancy Genetic Testing sales channel, distributors, customers, research findings and conclusion, appendix and data source.

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Pre-Pregnancy Genetic Testing Market : Drivers, Restraints, Opportunities, and Threats (20202025) - The Think Curiouser

Anthropologist Rayna Rapp will discuss the growth of genetic testing in reproduction in a virtual lecture, Wed., Nov. 11, 5:30 p.m.

Banking on DNA: Gendering the Ever-Expanding Horizon of Prenatal Genetic Testing and Reproductive Technology, a Bentson Deans Lecture, will consider the rapidly escalating role of genetic testing in reproduction and will highlight the benefits and burdens of intensified testing in family-making and their gendered implications. The knowledge and pressure to use such tests, scientists observe, has resulted in growing social and cultural awareness of disability rights, robust commercial investments in genome-based technologies, and the turn to big data in health research.

Rapp, a professor in NYUs Department of Anthropology and affiliated with NYUs Center for Disability Studies, is the author of the prize-winningTesting Women, Testing the Fetus: The Social Impact of Amniocentesis in America and of more than 100 articles and reviews on the politics of gender, medical anthropology, feminist theory, science studies, and disability studies.

An RSVP is required by emailing cas.events@nyu.edu. Zoom coordinates will be sent to attendees the day of the event.

Funded by theBentsonFoundation,BentsonDean's Lectures are traditionally delivered by current full-time College of Arts and Science professors as well as adjuncts and visiting professors who are leaders in their respective fields.

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The Implications of the Growing Role of Genetic TestingLecture by Anthropologist Rayna Rapp, Nov. 11 - NYU News

A recent market research report added to repository of Adroit Market Research is an in-depth analysis of Preimplantation Genetic Testing Market. On the basis of historic growth analysis and current scenario of Preimplantation Genetic Testing market place, the report intends to offer actionable insights on global market growth projections. Authenticated data presented in report is based on findings of extensive primary and secondary research. Insights drawn from data serve as excellent tools that facilitate deeper understanding of multiple aspects of global Preimplantation Genetic Testing market.

This report examines all the key factors influencing growth of global Preimplantation Genetic Testing market, including demand-supply scenario, pricing structure, profit margins, production and value chain analysis. Regional assessment of global Preimplantation Genetic Testing market unlocks a plethora of untapped opportunities in regional and domestic market places. Detailed company profiling enables users to evaluate company shares analysis, emerging product lines, pricing strategies, innovation possibilities and much more.

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The Preimplantation Genetic Testing Market carries out financial changes that occur year by years in market, with information about upcoming opportunities and risk to keeps you ahead of competitors. The report also describes top company profiles that present in market with trends worldwide. This research guided you for extending business.

The following manufacturers are covered in this report:

Thermo Fisher Scientific, Inc., Agilent Technologies, Inc., PerkinElmer, Inc., CooperSurgical, Inc., Beijing Genomics Institute (BGI), Abbott Laboratories, Natera, Inc., Genea Limited, Rubicon Genomics, Inc. and Oxford Gene Technology

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The report assesses key players in the Preimplantation Genetic Testing Market, studying their services, strategies, landmarks, growth plans, and recent developments. By studying multiple organizations covering small, medium, and large players the report enables emerging players to train themselves with knowledge of competition scenarios. The most critical aspect in the competitive landscape individual growth strategy is studied extensively by dwelling into the foregoing growth trajectory of the organization. Moreover, the study paints a picture of the individual standpoints of the players in the years to come, considering the drivers and trends.

It includes the major key players operating in the global regions. Several strategies adopted by top-level industries have been mentioned in this research report. Profiling of top key players has been done to get a detailed analysis of several industries. It helps to understand the global competition across the domestic and global platforms.

Global Preimplantation Genetic Testing market is segmented based by type, application and region.

Market by Types

by Test Type (Aneuploidy, Structural Chromosomal Abnormalities, Single Gene Disorders, X-linked Disorders, HLA Typing, Gender Identification) and Technology (Next Generation Sequencing, Polymerase Chain Reaction, Fluorescent In-Situ Hybridization, Comparative Genomic Hybridization, Single Nucleotide Polymorphism)

Regional Overview:

A thorough evaluation and assessment study of growth prospects through the forecast spam, 2020-25 has also been significantly included in this report. Proceeding beyond regional scope, country specific analysis with prime identification of production and consumption channels, logistics, investor preferences besides vendor activities have been discussed at length in this report, committed to encourage vendor specific business decisions, eying steady and strong foothold in the competition spectrum.

Some Points from Table of Content

Chapter 1: Market Overview, Drivers, Restraints and Opportunities, Segmentation overviewChapter 2: Market Competition by ManufacturersChapter 3: Production by RegionsChapter 4: Consumption by RegionsChapter 5: Production, By Types, Revenue and Market share by TypesChapter 6: Consumption, By Applications, Market share (%) and Growth Rate by ApplicationsChapter 7: Complete profiling and analysis of ManufacturersChapter 8: Manufacturing cost analysis, Raw materials analysis, Region-wise manufacturing expensesChapter 9: Industrial Chain, Sourcing Strategy and Downstream BuyersChapter 10: Marketing Strategy Analysis, Distributors/TradersChapter 11: Market Effect Factors AnalysisChapter 12: Market ForecastChapter 13: Preimplantation Genetic Testing Research Findings and Conclusion, Appendix, methodology and data source.

Points Covered in the Report:

The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc. The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 12 years data history and forecast. The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail. Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements. The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

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Global Preimplantation Genetic Testing Market: In-depth Analysis of Market Share, Size, Segmentaion, Top Players across the Region and Globe, Current...

The Global Direct-to-Consumer Genetic Testing (DTC-GT) Market report by dataintelo provides a detailed analysis of the area marketplace expanding; competitive landscape; global, regional, and country-level market size; impact market players; market growth analysis; market share; opportunities analysis; product launches; recent developments; sales analysis; segmentation growth; technological innovations; and value chain optimization. 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.

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Market Segmentation

The Global Direct-to-Consumer Genetic Testing (DTC-GT) Market has been divided into product types, application, and regions. These segments provide accurate calculations and forecasts for sales in terms of volume and value. This analysis can help customers increase their business and take calculated decisions.

By Product Types,Over-the-Counter (OTC) ChannelOnline Channel

By Applications,Ancestry-based Genetic TestsHealth and Wellness-based Genetic TestsEntertainment-based Genetic Tests

By Regions and Countries,Asia Pacific: China, Japan, India, and Rest of Asia PacificEurope: Germany, the UK, France, and Rest of EuropeNorth America: The US, Mexico, and CanadaLatin America: Brazil and Rest of Latin AmericaMiddle East & Africa: GCC Countries and Rest of Middle East & Africa

The regional analysis segment is a highly comprehensive part of the report on the global Direct-to-Consumer Genetic Testing (DTC-GT) market. This section offers information on the sales growth in these regions on a country-level Direct-to-Consumer Genetic Testing (DTC-GT) market.

The historical and forecast information provided in the report span between 2018 and 2026. The report provides detailed volume analysis and region-wise market size analysis of the market.

Competitive Landscape of the Direct-to-Consumer Genetic Testing (DTC-GT) Market

The chapter on competitive landscape provides information about key company overview, global presence, sales and revenue generated, market share, prices, and strategies used.

Major players in the global Direct-to-Consumer Genetic Testing (DTC-GT) Market include 24GeneticsAncestry.com LLCDante LabsEasyDNAGenebaseAtlas BiomedFamily Tree DNAMyHeritageMapmygenome

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The Direct-to-Consumer Genetic Testing (DTC-GT) Market Report Addresses:

The Report Provides:

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Direct-to-Consumer Genetic Testing (DTC-GT) Market 2020 Global Share, Growth, Size, Opportunities, Trends, Regional Overview, Leading Company Analysis...

Preimplantation Genetic Testing Market Overview:

Reports and Data has recently published a new research study titled Global Preimplantation Genetic Testing Market that offers accurate insights for the Preimplantation Genetic Testing market formulated with extensive research. The report explores the shifting focus observed in the market to offer the readers data and enable them to capitalize on market development. The report explores the essential industry data and generates a comprehensive document covering key geographies, technology developments, product types, applications, business verticals, sales network and distribution channels, and other key segments.

The report is further furnished with the latest market changes and trends owing to the global COVID-19 crisis. The report explores the impact of the crisis on the market and offers a comprehensive overview of the segments and sub-segments affected by the crisis. The study covers the present and future impact of the pandemic on the overall growth of the industry.

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Competitive Landscape:

The global Preimplantation Genetic Testing market is consolidated owing to the existence of domestic and international manufacturers and vendors in the market. The prominent players of the key geographies are undertaking several business initiatives to gain a robust footing in the industry. These strategies include mergers and acquisitions, product launches, joint ventures, collaborations, partnerships, agreements, and government deals. These strategies assist them in carrying out product developments and technological advancements.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

Natera, Inc.; CooperSurgical, Inc.; F. Hoffmann-La Roche AG; Illumina, Inc.; IGENOMIX; and others

An extensive analysis of the market dynamics, including a study of drivers, constraints, opportunities, risks, limitations, and threats have been studied in the report. The report offers region-centric data and analysis of the micro and macro-economic factors affecting the growth of the overall Preimplantation Genetic Testing market. The report offers a comprehensive assessment of the growth prospects, market trends, revenue generation, product launches, and other strategic business initiatives to assist the readers in formulating smart investment and business strategies.

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Test Type (Revenue, USD Million; 20162026)

Type (Revenue, USD Million; 20162026)

Application(Revenue, USD Million; 20162026)

End Use (Revenue, USD Million; 20162026)

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Key Coverage in the Preimplantation Genetic Testing Market Report:

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Preimplantation Genetic Testing Market Analysis, Size, Market Trends, Latest Technology and Cost Structures with Future Forecasts to 2027 - PRnews...

The global Predictive Genetic Testing market is forecasted to reach a market value of ~US$ XX Mn/Bn by the end of 2029 registering a CAGR growth of around XX% during the forecast period (2019-2029). The recent market report provides a detailed analysis of the current structure of the Predictive Genetic Testing market along with the estimated trajectory of the market over the course of the stipulated timeframe.

The report provides an in-depth assessment of the numerous factors that are anticipated to impact the market dynamics with utmost precision and accuracy. The SWOT and Porters Five Forces Analysis provides a clear picture about the current operations of the various market players operating in the global Predictive Genetic Testing market.

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Segmentation analysis

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

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

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

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

The report ponders over the market scenario in various geographies and highlights the major opportunities, trends, and challenges faced by market players in each region. An in-depth country wise analysis of each major region provides readers a deep understanding of the regional aspects of the market including, the market share, pricing analysis, revenue growth, and more.

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The market report on the Predictive Genetic Testing market addresses some important questions such as:

Crucial data enclosed in the report:

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Increasing Government Investments and Favorable Policies to Aid the Growth of the Predictive Genetic Testing Market 2019 2029 - Eurowire

NEW YORK, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Axovant Gene Therapies Ltd. (NASDAQ: AXGT), a clinical-stage company developing innovative gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has lifted its clinical hold and cleared the Investigational New Drug (IND) Application to initiate a registrational study of AXO-AAV-GM2 gene therapy to treat patients with Tay-Sachs disease and Sandhoff disease. AXO-AAV-GM2 is the first investigational gene therapy to achieve IND clearance for Tay-Sachs and Sandhoff diseases. The Company received a letter from the FDA indicating that it has satisfactorily addressed all issues related to the clinical hold.

The IND clearance of AXO-AAV-GM2, the first potentially curative treatment for Tay-Sachs and Sandhoff diseases to enter the clinic, marks a seminal moment for the entire GM2 gangliosidosis community. Along with AXO-AAV-GM1 for GM1 gangliosidosis, todays announcement represents the second IND clearance for Axovants gene therapy pipeline in the last 12 months, said Gavin Corcoran, M.D., Chief R&D Officer of Axovant. AXO-AAV-GM1 and AXO-AAV-GM2 are the first gene therapies to enter active clinical development in their indications. Each program captures the essence of our mission to liberate patients from debilitating neurological diseases by rapidly advancing these gene therapy programs into clinical development. We look forward to working with our study investigators, academic partners, the patient community, and families to begin enrollment in the study promptly.

Sue Kahn, Executive Director of the National Tay-Sachs & Allied Diseases Association (NTSAD), added, This is a big step toward a potential therapy for the GM2 community. It has been a long journey since NTSAD started supporting this promising gene therapy research in 2006. We are thrilled that it is now entering the clinic, bringing tremendous hope to families and the entire NTSAD community.

Axovant aims to advance the program through strategic partnerships with leading research organizations. The Company recently announced a partnership with Viralgen, an AskBio subsidiary, to support AAV-based vector manufacturing of clinical trial material for the registrational study. Additionally, through an existing genetic testing collaboration with Invitae, ongoing partnership with GM2 gangliosidosis patient groups, and collaboration with leading academic researchers at the University of Massachusetts Medical School and Massachusetts General Hospital, Axovant expects to begin patient identification and site startup activities in preparation for dosing children in the planned clinical study.

AXO-AAV-GM2 is an investigational gene therapy for Tay-Sachs and Sandhoff diseases, which are rare, monogenic neurodegenerative lysosomal storage disorders caused by mutations in the genes that encode -Hexosaminidase A, HEXA and HEXB. Children affected by Tay-Sachs and Sandhoff diseases suffer from a progressively debilitating disease course and reduced life expectancy. AXO-AAV-GM2 delivers two vectors encoding the HEXA and HEXB genes directly to the central nervous system to produce a fully functional -Hexosaminidase A enzyme. In 2019, clinical evidence from two patients under an investigator-initiated study found that treatment with AXO-AAV-GM2 was generally well-tolerated and associated with improved bioactivity outcomes. In addition, the data demonstrated the attainment of normal neurodevelopmental milestones and improvement in myelination. AXO-AAV-GM2 has been granted Orphan Drug and Rare Pediatric Disease Designation by the FDA.

The study will enroll both infantile and juvenile subjects with GM2 gangliosidosis in the U.S. The two-part trial, sponsored by Axovant, will consist of (1) a dose ranging cohort evaluating the safe and efficacious dose of the gene therapy, followed by (2) an efficacy cohort, both of which form the basis of the registrational program. Terence R. Flotte, M.D., Professor of Pediatrics and Dean at the University of Massachusetts Medical School, will serve as principal investigator on the clinical trial.

About AXO-AAV-GM2

AXO-AAV-GM2 is an investigational gene therapy for GM2 gangliosidosis (also known as Tay-Sachs and Sandhoff diseases), a set of rare and fatal pediatric neurodegenerative genetic disorders caused by defects in theHEXA(leading to Tay-Sachs disease) orHEXB(leading to Sandhoff disease) genes that encode the two subunits of the -hexosaminidase A (HexA) enzyme. These genetic defects lead to progressive neurodegeneration and shortened life expectancy. AXO-AAV-GM2 aims to restore HexA function by introducing a functional copy of theHEXAandHEXBgenes via delivery of two co-administered AAVrh8 vectors.

About Axovant Gene Therapies

Axovant Gene Therapies is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurodegenerative diseases. Our current pipeline of gene therapy candidates target GM1 gangliosidosis, GM2 gangliosidosis (also known as Tay-Sachs disease and Sandhoff disease), and Parkinsons disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit http://www.axovant.com.

In 2018, Axovant licensed exclusive worldwide rights from the University of Massachusetts Medical School for the development and commercialization of gene therapy programs for GM1 gangliosidosis and GM2 gangliosidosis, including Tay-Sachs and Sandhoff diseases.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "will," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. For example, all statements Axovant makes regarding costs associated with its operating activities are forward-looking. All forward-looking statements are based on estimates and assumptions by Axovants management that, although Axovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Axovant expected. Such risks and uncertainties include, among others, the impact of the Covid-19 pandemic on our operations, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the development of a suspension-based manufacturing process; the scaling up of manufacturing, the expectations for regulatory submissions and approvals; the continued development of our gene therapy product candidates and platforms; Axovants scientific approach and general development progress; and the availability or commercial potential of Axovants product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Axovants most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 11, 2020, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Axovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:

Investors

Parag MeswaniAxovant Gene Therapies Ltd.(212) 547-2523investors@axovant.com

Media

Josephine Belluardo, Ph.D. LifeSci Communications(646) 751-4361jo@lifescicomms.commedia@axovant.com

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Axovant Gene Therapies Announces FDA Clearance of IND for AXO-AAV-GM2 Gene Therapy in Tay-Sachs and Sandhoff Diseases - GlobeNewswire

The global direct-to-consumer genetic testing market is estimated to surpass $2,565.7 million by 2027, exhibiting a CAGR of 12.5% from 2020 to 2027.

The report aims to offer a clear picture of the current scenario and future growth of the global Direct-to-Consumer Genetic Testing market. The report provides scrupulous analysis of global market by thoroughly reviewing several factors of the market such as vital segments, regional market condition, market dynamics, investment suitability, and key players operating in the market. Besides, the report delivers sharp insights into present and forthcoming trends & developments in the global market.

The report articulates the key opportunities and factors propelling the global Direct-to-Consumer Genetic Testing market growth. Also, threats and limitations that have the possibility to hamper the market growth are outlined in the report. Further, Porters five forces analysis that explains the bargaining power of suppliers and consumers, competitive landscape, and development of substitutes in the market is also sketched in the report.

For More Detail Insights, Download Sample Copy of the Report at: https://www.researchdive.com/download-sample/504

The report reveals various statistics such as predicted market size and forecast by analyzing the major factors and by assessing each segment of the global Direct-to-Consumer Genetic Testing market. Regional market analysis of these segments is also provided in the report. The report segments the global market into four main regions including Asia-Pacific, Europe, North America, and LAMEA. Moreover, these regions are sub-divided to offer an exhaustive landscape of the Direct-to-Consumer Genetic Testing market across key countries in respective regions. Furthermore, the report divulges some of the latest advances, trends, and upcoming opportunities in every region.

Furthermore, the report profiles top players active in the global Direct-to-Consumer Genetic Testing market. A comprehensive summary of 10 foremost players operating in the global market is delivered in the report to comprehend their position and footmark in the industry. The report highlights various data points such as short summary of the company, companys financial status and proceeds, chief company executives, key business strategies executed by company, initiatives undertaken & advanced developments by the company to thrust their position and grasp a significant position in the market.

RESEARCH METHODOLOGY

The research report is formed by collating different statistics and information concerning the Direct-to-Consumer Genetic Testing market. Long hours of deliberations and interviews have been performed with a group of investors and stakeholders, including upstream and downstream members. Primary research is the main part of the research efforts; however, it is reasonably supported by all-encompassing secondary research. Numerous product type literatures, company annual reports, market publications, and other such relevant documents of the leading market players have been studied, for better & broader understanding of market penetration. Furthermore, medical journals, trustworthy industry newsletters, government websites, and trade associations publications have also been evaluated for extracting vital industry insights.

Connect with Our Analyst to Contextualize Our Insights for Your Business:https://www.researchdive.com/connect-to-analyst/504

KEY MARKET BENEFITS

KEY MARKET SEGMENTS

The global Direct-to-Consumer Genetic Testing market is segmented on the basis of the following:

Global Direct-to-Consumer Genetic Testing Market By Product Type:

Global Direct-to-Consumer Genetic Testing Market By Applications:

Global Direct-to-Consumer Genetic Testing Market By Regions:

Top Leading key players stated in Global Direct-to-Consumer Genetic Testing Market report are:

Ancestry, Color Genomics, Easy DNA, FamilytreeDNA (Gene By Gene), Full Genome Corporation, Helix OpCo LLC, Identigene, Karmagenes, Living DNA, Mapmygenome, MyHeritage, Pathway genomics.

The report also summarizes other important aspects including financial performance, product portfolio, SWOT analysis, and recent strategic moves and developments of the leading players.

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Top Scenario: Direct-to-Consumer Genetic Testing Market 2020 to Witness Excellent Long-Term Growth Outlook Report by ResearchDive - The Think...

Nicholas C. Rohs, MD, discusses the importance of genetic testing in nonsmall cell lung cancer.

Nicholas C. Rohs, MD, assistant professor of medicine, hematology, and medical oncology, Icahn School of Medicine, Mount Sinai, discusses the importance of genetic testing in nonsmall cell lung cancer (NSCLC).

All patients with NSCLC, particularly those with lung adenocarcinoma, should undergo genetic testing, says Rohs.

An actionable mutation can be identified in about two-thirds of patients with lung adenocarcinoma, Rohs says.These actionable mutations play an important role in the treatment selection process. Oftentimes, these actionable mutations are somatic mutations rather than germline mutations, says Rohs.

Notably, several effective and well-tolerated oral therapiesare available for patients who harbor anEGFRmutation, Rohs adds.

Additionally, although it was believed that KRAS was an undruggable target,early responses with modified KRAS inhibitors have been observed in clinical trials.

The role of KRAS mutations has garnered significantexcitement in NSCLC, and is the focus of ongoing research efforts, Rohs concludes.

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Dr. Rohs on the Importance of Genetic Testing in NSCLC - OncLive

November 02, 2020 -Broad-based genetic testing could identify inherited genetic mutations and accelerate precision medicine therapies for patients with cancer, according to a study published in JAMA Oncology.

Hereditary factors play a key role in the development of many cancers, researchers at Mayo Clinics Center for Individualized Medicine noted. Identifying genetic predispositions for certain cancers can have significant implications for treatment decisions, interventions, cancer screenings, and genetic testing for patients and close relatives.

Selecting patients for genetic testing has traditionally been based on pathologic features of the cancer, age at diagnosis, family history of cancer, and other factors named in clinical guidelines. Few studies have examined the impact of broad-based testing for gene mutations in patients with cancer compared with more traditional methods of selection.

Over the course of two years, Mayo Clinic researchers provided free genetic testing and counseling for 3,084 patients as part of their standard cancer care. The project included a wide range of cancer stages and types, such as breast, colorectal, lung, ovarian, pancreatic, bladder, and prostate cancers.

The results showed that with standard guidelines, physicians were only able to find 48 percent of patients with an inherited genetic mutation.

We found that 13.5 percent of patients had an inherited mutation in a gene associated with the development of their cancer, saidNiloy Jewel Samadder, MD, a Mayo Clinic gastroenterologist and hepatologist, who is the study's author.

More than half of the patients who developed cancer due to inherited mutations were being missed, and that has major implications for family members. Everyone has some risk of developing cancer, and in most cases the disease develops by chance. However, some people are genetically predisposed to developing certain types of cancer, such as breast or colon cancers.

When researchers examined the effects of a genetic mutation discovery, the team found that one-third of patients with the highest-risk cancer genes had a change in their medical management, including the type of surgery or chemotherapy they received.

This targeted treatment would have been lost if the patients had not received genetic testing, Samadder stated.

The results demonstrate the importance of genetic testing for all patients, and not just specific individuals.

Genetic testing is underutilized in cancer care, both for patients and for their families, often due to outdated guidelines that restrict testing to a narrow group of high-risk patients, saidRobert Nussbaum, MD,chief medical officer ofInvitae Corporation.

All cancer patients should have access to complete genetic information that can guide their care and inform their families' health.

Additionally, high-risk patients should share the heritable-cause of the disease with their relatives, which will allow family members to pursue disease care for earlier cancer management and detection.

We can help prevent cancer in their loved ones because it is genetic, and they share these cancer-causing genetic changes with their children, siblings and others in their families, Samadder said. We can target prevention strategies for those high-risk individuals and hopefully prevent cancer altogether in future generations of their family.

All blood-related family members of patients found to have a genetic mutation were offered free genetic testing. Overall, one in five of these family members underwent testing, the researchers said.

Going forward, the research team hopes to be able to incorporate the studys results into the care of all patients with cancer at Mayo Clinic. The study demonstrates the potential for broad genetic testing to accelerate the development of precision medicine therapies for cancer.

Steps are being taken to ensure all patients are offered genomic sequencing to better understand the genes that led to the development of their cancer, and how to precisely target treatment and improve survival, said Samadder.

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Genetic Testing Can Lead to Precision Medicine Therapies for Cancer - HealthITAnalytics.com

In a finding that bolsters the field of personalized medicine, a new large-scale study from the Mayo Clinic reports that one in eight cancer patients they followed had an inherited mutation that increases their risk of developing a malignancy. Further, the study showed that more than half of all patients with such mutations were being missed and therefore probably not receiving optimal treatment.

The study was carried out by scientists at Mayo Clinics Center for Individualized Medicine. They conducted genetic testing in more than 3,000 patients previously diagnosed with cancer at Mayo Clinic Cancer Center locations in Arizona, Florida, and Minnesota. Their report was published in the October 30 online edition ofJAMA Oncology. doi: 10.1001/jamaoncol.2020.6252

We found that 13.5% of patients had an inherited mutation in a gene associated with the development of their cancer, says Niloy Jewel Samadder, MD, a Mayo Clinic gastroenterologist and hepatologist, who is the studys lead author. Everyone has some risk of developing cancer, and in most cases the disease develops by chance. However, some people are genetically predisposed to developing certain types of cancer, such as breast or colon cancers.

The study confirms that nearly 10%-25% of cancer-causing mutations are inherited. It also suggests that patients with these mutations are being overlooked, when they could be candidates for targeted, or personalized, therapies drugs that act specifically against target molecules or processes that are known to cause or contribute to the development or progression of cancers.

The market for targeted cancer therapies is one of the biggest and fastest growing sectors in all of pharmaceuticals. More than a dozen such treatments are already on the market and they are often given fast-track designation as candidate drugs, which makes them particularly lucrative development projects. This market currently includes multiple drugs for both solid tumors and blood cancers, including early entrants to this market: imatinib mesylate (Gleevec), trastuzumab (Herceptin), and cetuximab (Erbitux). Findings such as this one from Mayo clinic should encourage growth and expansion of this market.

In its two-year Interrogating Cancer Etiology Using Proactive Genetic Testing (INTERCEPT) study, Mayo Clinic provided free genetic testing and counseling to 3,084 Mayo Clinic patients as part of their standard cancer care. The project, representing the largest known multicenter study of universal testing of patients with cancer, included a broad mix of cancer stages and types, including breast, colorectal, lung, ovarian, pancreatic, bladder, prostate and endometrial cancers.

The researchers were surprised to find that the standard guidelines physicians relied on to determine which patients with cancer should undergo genetic testing only identified 48% of the patients with an inherited genetic mutation.

More than half of the patients who developed cancer due to inherited mutations were being missed, and that has major implications for family members, Samadder says. Everyone has some risk of developing cancer, and in most cases the disease develops by chance. However, some people are genetically predisposed to developing certain types of cancer, such as breast or colon cancers.

During the study, the researchers found that one-third of the patients with the highest-risk cancer genes had a change in their medical management when a mutation was discovered. That change could include the type of surgery or chemotherapy they received.

This targeted treatment would have been lost if the patients had not received genetic testing, Samadder emphasizes.

Genetic testing is underutilized in cancer care, both for patients and for their families, often due to outdated guidelines that restrict testing to a narrow group of high-risk patients, says Robert Nussbaum, MD, chief medical officer of Invitae Corporation. All cancer patients should have access to complete genetic information that can guide their care and inform their families health. Nussbaum was a contributing author on the study.

Besides helping to guide optimal treatment for current patients, testing for these mutations can also benefit family members by encouraging them to undergo early detection testing and to get proper treatment if they also develop malignancies.

We can help prevent cancer in their loved ones because it is genetic, and they share these cancer-causing genetic changes with their children, siblings and others in their families, Samadder explains. We can target prevention strategies for those high-risk individuals and hopefully prevent cancer altogether in future generations of their family.

In this Mayo study, all blood-related family members of patients found to have a genetic mutation were offered free genetic testing, and one in five of those people opted for testing. The researchers say that the next steps will be to incorporate the study findings into the care of all patients with cancer at Mayo Clinic.

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One in Eight Cancer Patients Harbors Inherited Mutation that Increases Risk of Disease Development - Clinical OMICs News