Loading, Please Wait...
SALT LAKE CITY, March 06, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that its Myriad Women’s Health business unit has published the first data-driven evaluation of commonly stated recommendations of panel inclusion criteria for expanded carrier screening (ECS) in the journal Genetics in Medicine. The key finding is that the interpretation of current criteria are ambiguous and should be clarified such that ECS can more broadly identify couples at increased risk of passing on serious inherited genetic conditions to their children.
In an analysis of more than 55,000 patients tested with the Foresight®️ 176-condition ECS panel, the study identified how many carriers and at-risk couples would have been missed if the panel were constructed using different interpretations of existing professional organization criteria. For instance, one criterion states that screened conditions should have a carrier rate of at least 1-in-100, yet it is not clear whether this threshold applies to X-linked conditions or whether it must be exceeded in any ethnicity or in all ethnicities. The study showed that these distinctions are clinically consequential because depending on the definition used, a compliant panel identifies between 11 percent (3 conditions) and 89 percent (38 conditions) of at-risk couples relative to the Foresight 176-condition panel. With the most restrictive interpretation – where the carrier rate threshold must be exceeded in all ethnicities – common conditions like cystic fibrosis would be omitted from ECS. Clarifying the current guidelines to include a 1-in-100 carrier rate for any ethnicity results in a 38-condition panel that identifies 89 percent of at-risk couples.
“Existing professional opinions can be interpreted in many ways, which can create confusion and limit the identification of couples at risk for pregnancies affected with serious conditions,” said James Goldberg, M.D., board certified maternal fetal medicine specialist, medical geneticist and chief medical officer, Myriad Women’s Health. “Our study provides data that will be helpful to professional organizations as they update their guidelines to enable screening of many conditions in a clinically responsible manner, with the goal of maximizing the clinical utility of ECS for prospective parents.”
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 Prequel 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 a data-driven evaluation of commonly stated recommendations of panel inclusion criteria for expanded carrier screening (ECS) published in the journal Genetics in Medicine; the key finding that current criteria are unclear and should be updated such that ECS can more broadly identify couples at increased risk of passing on serious inherited genetic conditions to their children; the study providing data that will be helpful to professional organizations as they update their guidelines to enable screening of many conditions in a clinically responsible manner, with the goal of maximizing the clinical utility of ECS for prospective parents; 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.
|Media Contact:||Ron Rogers||Investor Contact:||Scott Gleason|
|(801) 584-3065||(801) 584-1143|