Myriad Genetics Supports New ACMG Recommendation Statement on Increasing Access to Carrier Screening for All Ethnicities
SALT LAKE CITY, July 21, 2021 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced its support for a new recommendation statement by the American College of Medical Genetics and Genomics (ACMG), advising that genetic carrier screening be offered to all people who are pregnant or considering a pregnancy. The statement recommends screening for more than 110 genetic disorders regardless of family history or ethnicity. ACMG previously recommended more limited carrier screening and for only certain ethnicities.
The new recommendation statement makes ACMG one of the first medical societies to advise that carrier screening for conditions besides only cystic fibrosis and spinal muscular atrophy be offered as a first-line test for all potential parents, no matter their ethnicity. Additionally, ACMG recommends that insurers cover the costs of such tests, which will improve equitable patient access. The statement is partially based on a ground-breaking study by Myriad Genetics, published in the Journal of the American Medical Association, demonstrating that when carrier screening is limited to only certain ethnicities, a substantial number of pregnancies affected by serious genetic conditions fail to be identified. For example, ethnicity-based screening guidelines identify only 6% of affected pregnancies among East Asians and 21% of affected pregnancies among Hispanics. Screening without regard to ethnicity, as ACMG has recommended, avoids such inequity in care. Myriad Genetics has been a leader in establishing the evidence base for carrier screening and for developing inclusive products that serve patients of all ancestries. Seven studies by Myriad were cited in the new statement, including those that demonstrate the clinical utility of carrier screening, reveal the limitations of an ethnicity-based approach, and establish a system of classifying the severity of genetic disease.
“We applaud ACMG for its new, and more inclusive statement, recommending carrier screening to patients of all ethnicities for a broad panel of conditions,” said Nicole Lambert, president of Myriad Genetic Laboratories. “Increasing access to carrier screening will enable more families to benefit from understanding their risk to have a child with a severe genetic condition.”
Carrier screening is a type of genetic testing that determines the risk of carrying a genetic variant associated with a serious, inherited disease that could be passed on to a child. In most cases, a child must inherit the genetic variant from each parent for a disease, such as cystic fibrosis, to be present in the child. Knowing this information in the family planning stages, or early in pregnancy, can help parents prepare for the birth of an affected child.
About Foresight® Carrier Screen
The Myriad Foresight Carrier Screen is designed to maximize detection of couples at-risk for passing serious and prevalent conditions to children. The Foresight Universal Panel screens for 175+ clinically actionable conditions that gives meaningful information to patients and healthcare providers. Additionally, Foresight offers the most extensively validated technology, which yields exemplary detection rates for the vast majority of genes on the panel (>99% across ethnicities) which means patients can trust both positive and negative results.
About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and wellbeing for all, empowering individuals with vital genetic insights and enabling healthcare providers to better detect, treat and prevent disease. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, EndoPredict, 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.
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 ACMG’s recommendation statement, including the anticipated impact of that recommendation on patient access to carrier screening; the benefits of increased access to carrier screening; and the Company’s 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; risks related to our ability to efficiently and flexibly manage our business amid uncertainties associated with COVID-19; the risk that sales and profit margins of our existing molecular diagnostic tests may decline or that we may not be able to operate our business on a profitable basis; risks related to our ability to generate sufficient revenue from our existing product portfolio or in launching and commercializing new tests; risks related to changes in governmental or private insurers’ coverage and 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 in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests , including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; 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 the potential market opportunity for our products; 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 patents or enforcement in the United States and foreign countries; 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; risks related to the material weakness identified in our internal control over financial reporting, including the impact thereof and our remediation plan; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our Transition Report on Form 10-K for the six month transition period ended December 31, 2020, which was filed with the Securities and Exchange Commission on March 16, 2021, 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.
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