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Myriad Announces Publication of Foresight™ Carrier Screen Clinical Utility Study in Genetics in Medicine
Large Study Demonstrates that Expanded Carrier Screening Informs Couples’ Reproductive Choices and Pregnancy Management
SALT LAKE CITY, Oct. 23, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that results from a large clinical utility study using the Foresight™ Carrier Screen were published in the journal Genetics in Medicine. The key finding is that expanded carrier screening (ECS) prompted changes in pregnancy management that resulted in fewer births affected with serious genetic diseases. Foresight is the market-leading ECS and tests for more than 175 serious and clinically-actionable conditions.
“We now have the results from the largest-ever ECS study in parents at elevated risk of passing on an inherited condition to their children,” said James D. Goldberg, M.D., chief medical officer, Myriad Women’s Health. “The important news here is that couples used the information provided by the Foresight test to guide their decision making and help prevent the birth of an affected child.”
This study assessed the impact of ECS on planned and actual pregnancy management in the largest population of at-risk couples (ARCs) studied to date. 391 ARCs reported their actions and pregnancy management. The results show that among those screened before becoming pregnant, 77 percent planned or pursued actions to avoid having an affected offspring. Among those screened while pregnant, 37 percent elected prenatal diagnostic testing for that pregnancy, similar to the proportion of couples who choose prenatal diagnostic testing after screening positive for Down syndrome. Additionally, 166 subsequent pregnancies were reported by ARCs screened previously. Of these, 35 percent of pregnancies were achieved through in vitro fertilization with preimplantation genetic testing, effectively preventing the risk of an affected pregnancy.
“These findings provide strong evidence that ECS guides reproductive choices and impacts pregnancy outcomes,” said Dr. Goldberg. “Importantly, the results support the wider clinical adoption of expanded carrier screening and broader insurance coverage to achieve the best health outcomes for prospective parents and their children.”
The Foresight Carrier Screen is a genetic test that identifies couples who are at increased risk of passing on inherited conditions to their children. Foresight tests for more than 175 serious and clinically-actionable conditions. It is estimated that serious genetic conditions affect one in 300 pregnancies.
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 five strategic imperatives: build upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. 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 HRD, EndoPredict, Vectra, GeneSight, riskScore, Prolaris, ForeSight and Prelude 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 announced results from the clinical utility study using the Foresight™ Carrier Screen, published in the journal Genetics in Medicine; the key finding that expanded carrier screening (ECS) prompted changes in pregnancy management that resulted in fewer births affected with serious genetic diseases; support for wider clinical adoption of expanded carrier screening and broader insurance coverage to achieve the best health outcomes for prospective parents and their children; the estimated number of serious genetic conditions in pregnancies; 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: 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 decision in the lawsuit brought against us by the Association for Molecular Pathology et al; 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, 2018, 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.