Myriad Launches Proprietary AMPLIFY Technology, Further Increasing the Performance of its Prequel NIPS Test – GlobeNewswire

Posted: August 2, 2020 at 6:59 am

SALT LAKE CITY, July 29, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today that the company has launched its proprietary AMPLIFY technology, which further increases the performance of its Prequelnoninvasive prenatal screening (NIPS) test. The proprietary AMPLIFY process increases the fetal fraction of a NIPS sample by preferentially sequencing the fetal cell-free DNA fragments that circulate in a mothers blood. AMPLIFY technology enables more accurate detection of fetal chromosome abnormalities. In the analytical validation involving samples from more than 1,000 pregnant women, fetal fraction is 2.3 times greater on average with AMPLIFY than with standard NIPS. This improvement reduces false positive and false negative resultsincluding for common aneuploidies, expanded aneuploidies, microdeletions and a babys sex. For instance, false negative performance in common aneuploidies improves 45x with AMPLIFY technology. Additionally, no samples powered by AMPLIFY technology had a fetal fraction below four percent. Other laboratories may fail samples with less than four percent fetal fraction.

Prequel already provided highly accurate results and this proprietary technology further increases the sensitivity of our test, said Nicole Lambert, president of Myriad International, Oncology and Womens Health. With AMPLIFY, Prequel maintains an industry-leading low rate of failed samplesdelivering results to 99.9 percent of patients. The important clinical benefits are that each woman who receives the test can expect highly accurate NIPS results, regardless of body mass index (BMI), race, or ethnicity.

Up to 50 percent of pregnant women present with high BMI to their healthcare provider. Studies have demonstrated that BMI is not evenly distributed across ethnicities, and up to 24 percent of women with high BMI will not receive a result on standard NIPS platforms due to low fetal fraction. Women who dont receive a result may do no further prenatal screening at all; they may go through subsequent rounds of NIPS, or they may undergo invasive procedures such as an amniocentesis or chorionic villus sampling, which can increase the risk of miscarriage and add unnecessary expense to the US healthcare system. Prequel with AMPLIFY technology overcomes the limitations of standard NIPS in order to provide equity of care to pregnant women.

About Prequel Prenatal ScreenThe Myriad Prequel Prenatal Screen is a non-invasive 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 than 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 GeneticsMyriad 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 three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://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 CDx, Vectra, 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. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to launch of the Companys proprietary AMPLIFY technology; and the Companys 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; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; 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 decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); 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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