Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that its Myriad Women’s Health business unit will present results from two important studies at the 2019 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting that highlight the performance of its prenatal tests.
SALT LAKE CITY, April 2, 2019 –Myriad Genetics, Inc.,. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that its Myriad Women’s Health business unit will present results from two important studies at the 2019 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting that highlight the performance of its prenatal tests. The key findings are that the Foresight® Carrier Screen identifies 45 percent more couples at risk for having a child with cystic fibrosis than current guideline-based testing, and that the Prequel™ Prenatal Screen provides reliable results to 99.9 percent of patients spanning the entire spectrum of fetal-fraction levels.
“Our studies demonstrate the outstanding clinical performance of our tests in a general population of patients undergoing carrier and prenatal screening,” said James Goldberg, M.D., board certified maternal fetal medicine specialist, medical geneticist and chief medical officer, Myriad Women’s Health. “We believe these data will help inform medical guideline updates, support decision making and lead to better outcomes for couples.”
The key data are summarized below. Please visit Myriad Women’s Health at booth #1218 to learn more about our leading portfolio of women’s health products. Follow Myriad on Twitter via @myriadgenetics and @MyrWomensHealth and keep up to date with meeting news and updates by using the hashtag #ACMGMtg19.
Foresight Carrier Screen
Title: Sequencing as a First-Line Methodology for Cystic Fibrosis Carrier Screening
Presenter: Dale Muzzey, Ph.D., Myriad Women’s Health.
Date: Friday, April 5, 2019, 10:30 a.m. to 12:00 p.m.
Location: Poster 880
This study evaluated the performance of sequencing-based cystic fibrosis (CF) screening using the Foresight Carrier Screen compared to genotyping. Three carrier screening strategies were evaluated: 1. Genotyping 23 guideline-recommended genetic variants (CF23);
2. Sequencing all coding bases in the CFTR gene (NGS) using Foresight; and 3. Sequencing plus large copy-number variant identification (NGS+CNV) also using Foresight. The results show that among the 13,080 couples screened, 58 were determined to be couples at risk for a pregnancy affected by CF: 40 were detected by CF23-only screening, 17 additional couples by NGS, and one couple by NGS+CNV. Importantly, these findings demonstrate that using Foresight would increase the detection of at-risk couples by 45 percent relative to current guideline-based testing. Of the couples at risk for CF who were identified, 89 percent said they planned or pursued actions to reduce the risk of having a pregnancy affected by CF, which underscores the clinical utility of the Foresight Carrier Screen to provide actionable information to prospective parents.
“Current medical guidelines for cystic fibrosis recommend carrier screening via targeted genotyping of 23 frequent variants but that approach may miss many couples at risk,” said Goldberg. “Our findings suggest the CF guidelines should be updated to allow for modern NGS and variant interpretation that will enable more effective screening and better detection of at-risk couples.”
Prequel Prenatal Screen
Title: Avoiding Unnecessary Trade-Offs: Clinical Experience for a Noninvasive Prenatal Screen with Both Low Test Failure Rate and High Accuracy
Presenter: Susan Hancock, CGC, Myriad Women’s Health.
Date: Thursday, April 4, 2019, 10:00 a.m. to 11:00 a.m.
Location: Poster 911
This study retrospectively analyzed data from 58,105 women screened with the Prequel Prenatal Screen, which uses a whole genome sequencing approach to noninvasive prenatal screening (NIPS). Importantly, while Prequel measures fetal fraction, samples are not routinely failed due to fetal fraction being below a predetermined threshold. The results demonstrate that Prequel provided a test result for 99.9 percent of patients, meaning that only one in 1,000 received no result. In the cohort, a total of 572 cases tested positive for an aneuploidy or suspected aneuploidy and the clinical sensitivity and specificity levels were comparable to those observed for NIPS offerings with much higher failure rates. Critically, the study shows that performance would not be improved with the use of a fetal-fraction threshold. Rather, applying such a threshold to Prequel would serve only to cause thousands of women to receive a test failure and would unnecessarily delay the identification of a number of affected pregnancies.
“What this data demonstrates is the high accuracy of the Prequel test below a fetal fraction of four percent, meaning more patients receive reliable results the first time,” said Goldberg. “We believe the ability of the Prequel test to perform at any fetal-fraction level is unprecedented and makes it the most effective noninvasive prenatal screening test for aneuploidy available to clinicians today.”
About Foresight® Carrier Screen
The Myriad Foresight Carrier Screen is designed to maximize detection of at-risk couples for serious, prevalent, and clinically-actionable conditions. Foresight has a rigorous disease selection that focuses on 175+ conditions that provides meaningful information to patients. Additionally, Foresight offers superior technology with unmatched detection rates for the vast majority of genes on the panel (>99% across ethnicities) which means patients can trust both positive and negative results.
About PrequelTM Prenatal Screen
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, 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, 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 Company’s presentation of new data for its expanded carrier and noninvasive prenatal screens being featured at the 2019 Annual Clinical Genetics Meeting April 2-6, 2019 in Seattle; the studies demonstrating the outstanding clinical performance of our tests in a general population of patients undergoing carrier and prenatal screening; the Company’s belief that this data will help inform medical guideline updates, support decision making and lead to better outcomes for couples; the possibility that current medical guidelines for cystic fibrosis recommending carrier screening via targeted genotyping of 23 frequent variants may miss many couples at risk; the suggestion that CF guidelines should be updated to allow for modern NGS and variant interpretation that to enable more effective screening and better detection of at-risk couples; this data demonstrating the high accuracy of the Prequel test below a fetal fraction of four percent, meaning more patients receive reliable results the first time; the Company’s belief thatthe ability of the Prequel test to perform at any fetal-fraction level is unprecedented and makes it the most effective noninvasive prenatal screening test for aneuploidy available to clinicians today; 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.
