Myriad’s Prequel™ Prenatal Screen Demonstrates High Performance Across All Fetal-Fraction Levels in Women Undergoing Noninvasive Prenatal Screening
Clinical Study Shows Prequel Delivers an Industry Leading Low Test Failure Rate of 0.1%
SALT LAKE CITY, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN, “Myriad” or the “Company”), a global leader in molecular diagnostics and precision medicine, today announced that a new study of the Prequel™ Prenatal Screen was published online in the journal Ultrasound in Obstetrics and Gynecology. The key finding is that Prequel without a fetal-fraction threshold achieves high accuracy, while maintaining a low test-failure rate of one in 1000. The Prequel Prenatal Screen uses a whole genome sequencing approach to identify chromosomal abnormalities including trisomies 21, 18 and 13.
“This is the largest study of Prequel to date and demonstrates that it achieves high accuracy with an industry-low test failure rate of 0.1 percent in a general population of pregnant women,” said James Goldberg, M.D., board certified maternal fetal medicine specialist, medical geneticist and chief medical officer of Myriad Women’s Health. “For women who are overweight or have a compromised placenta, the findings are especially relevant because their pregnancies may have low fetal fraction.”
To assess the clinical performance of the Prequel Prenatal Screen, the study retrospectively analyzed data from more than 58,000 women, including 572 who tested positive for an aneuploidy or suspected aneuploidy (362 for trisomy 21, 142 for trisomy 18 and 68 for trisomy 13). Pregnancy outcomes were sought for all screen-positive patients and for thousands of patients who screened negative. Whereas some other NIPS offerings attempt to avoid false-negative results at low fetal fraction by failing nearly five percent of all samples, 999 out of every 1,000 women received a result with a single run of Prequel. Importantly, the clinical sensitivity and specificity levels observed with Prequel were high and comparable to those reported for the other commercial NIPS offerings that have the far higher test failure rates.
“What these findings mean is that Prequel performed comparably in women with high and low fetal fractions, which should give clinicians confidence in the results and help their patients make informed choices,” said Dr. Goldberg. “Importantly, had a fetal-fraction threshold been applied in this general population, one in 15 women would have received no result, which would have delayed the identification of chromosomal abnormalities and potentially lead to anxiety and multiple rounds of unnecessary invasive testing.”
About Prequel™ Prenatal Screen
The Myriad Prequel Prenatal Screen is a noninvasive prenatal screen (NIPS) that uses cell-free DNA (cfDNA) to determine if a pregnancy is at an increased risk for chromosome abnormalities, such as Down syndrome. Compared to screening methods which use maternal age, ultrasound and serum screening, Prequel has been shown to be superior by achieving a lower false-positive rate and false-negative rate than these other methods. Among other NIPS, Prequel has an industry leading test failure rate of 0.1 percent. The Prequel Prenatal Screen can be ordered with the Foresight Carrier Screen and offered to all women, including those with high body mass index, and 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: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice CDx, 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 performance of the Prequel test; 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, 2019, 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.
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