Myriad Announces Prequel™ Prenatal Screen with Expanded Aneuploidy Analysis for all 23 Chromosome Pairs

SALT LAKE CITY, Feb. 11, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that its Myriad Women’s Health subsidiary has enhanced the to include all 23 chromosome pairs rather than just the standard five chromosomes (13, 18, 21, X and Y) previously tested.  Aneuploidies refer to extra or missing chromosomes that can lead to poor reproductive health outcomes.  The expanded Prequel screen will be available to clinicians and patients starting Feb. 19, 2019. 

“The goal of noninvasive prenatal screening (NIPS) is to provide women with information about the health of the pregnancy,” said James Goldberg, M.D., board certified medical geneticist and chief medical officer, Myriad Women’s Health.  “Our expanded Prequel Prenatal Screen now provides patients with a comprehensive assessment of all 23 chromosome pairs for aneuploidies, which improves the detection of aneuploidies by about 30 percent, expanding the clinical utility of the screen.”

Prequel Prenatal Screen with expanded aneuploidy analysis can potentially improve birth outcomes by identifying more pregnancies at risk for birth defects and syndromes, as well as those at risk for pregnancy complications due to these chromosome changes in the placenta. This improves the opportunity for better monitoring, specialized ultrasounds and targeted prenatal diagnosis.

“Every woman who wants to know more about her pregnancy should be offered the Prequel Prenatal Screen,” said Goldberg.  “In addition to testing all 23 chromosome pairs, Prequel has an industry-leading low test failure rate of 0.1 percent, which means patients receive reliable results the first time without the need for retesting.”

About

The Myriad Prequel Prenatal Screen is a noninvasive prenatal screen that uses cell-free DNA (cfDNA) to determine if a pregnancy is at an increased risk for chromosome abnormalities, such as Down syndrome.  Prequel has been shown to be superior to screening methods that use maternal age, ultrasound and serum screening.  Additionally, Prequel has a lower false-positive rate and false-negative rate than these other methods.  The Prequel Prenatal Screen can be ordered with the Foresight Carrier Screen and offered to all women, including those with high body mass index, an ovum donor, or a twin pregnancy. 

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: .

           

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 launch of the to include all 23 chromosome pairs rather than just the standard five chromosomes (13, 18, 21, X and Y) previously tested; the expanded Prequel screen being available to clinicians and patients starting Feb. 19, 2019; the expanded Prequel Prenatal Screen now providing patients with a comprehensive assessment of all 23 chromosome pairs for aneuploidies, improving the detection of aneuploidies by about 30 percent, and expanding the clinical utility of the screen; the potential of the Prequel Prenatal Screen with expanded aneuploidy analysis to improve birth outcomes by identifying more pregnancies at risk for birth defects and syndromes, as well as those at risk for pregnancy complications due to these chromosome changes in the placenta; the Prequel testing having a low test failure rate of 0.1 percent, meaning patients receive reliable results the first time without the need for retesting; 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.

¹ Pescia, G. et al. Cell-free DNA testing of an extended range of chromosomal anomalies: clinical experience with 6,388 consecutive cases. Genet. Med. (2016). doi:10.1038/gim.2016.72