Results Show 25 Percent of All Reported Variants of Uncertain Significance Were Reclassified over a 10-Year Period
SALT LAKE CITY, Sept. 25, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a worldwide leader in personalized medicine, today announced that results from a landmark study of variant classifications following hereditary cancer genetic testing were published in the Journal of the American Medical Association (JAMA).
“This is the first large, robust study to quantify the prevalence of variant reclassification of hereditary cancer testing in a large commercial laboratory, underscoring Myriad’s commitment to advancing the science of genetic testing,” said Susan Manley, CGC, MBA, vice president of Medical Services at Myriad. “Importantly, this study underscores the need for clinicians to use a clinical laboratory that provides timely variant reclassification information to ensure appropriate medical care of patients and their relatives.”
This was a retrospective study of individuals who had genetic testing from 2006-2016 at Myriad Genetics. Genetic variants were classified as Benign, Likely Benign, Variant of Uncertain Significance, Likely Pathogenic, or Pathogenic. The primary objective of this study was to measure the frequency and types of variant reclassification.
The results showed that 1.45 million individuals had genetic testing in the 10-year time period and 59,955 amended reports were issued due to variant reclassification. Importantly, 25 percent of all reported variants of uncertain significance were reclassified, with 91 percent downgraded to Benign/Likely Benign and 9 percent upgraded to Pathogenic/Likely Pathogenic.
“The implications of this study are three-pronged. Physicians need to be aware of how rapidly knowledge about gene variants is advancing and that reclassifications are common. Labs need to review gene variant information on a regular basis and alert physicians to changes. Finally, patients and their family members need to be made aware of reclassifications by their physicians so they can make well-informed choices,” said Theodora Ross, M.D., Ph.D., senior author of the study and professor of Internal Medicine at the University of Texas Southwestern Medical Center.
Myriad is unique in addressing these three goals through its proprietary myVision® variant classification program that employs multiple methods for variant interpretation to ensure that patients and their physicians receive the latest in scientific advances. In the last year alone, Myriad has issued more than 20,000 amended test reports with uncertain variant reclassifications.
“Myriad’s commitment to provide the most accurate testing doesn’t stop when patients’ receive their initial test result,” said Manley. “We offer Myriad patients and their families a commitment that lasts a lifetime.”
About myVision® Variant Classification
Myriad Genetic Laboratories is the industry leader in variant classification and reclassification. Over the past 22 years, Myriad has conducted millions of genetic tests for hereditary cancer. The resulting analysis and interpretation of the variant database support the Myriad commitment to reduce VUS in genetic testing. Click here to learn more about our myVision program.
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 Prelude 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 publication and results of the Variant Reclassification Study in the Journal of the American Medical Association; the need for clinicians to use a clinical laboratory that provides timely variant reclassification information to ensure appropriate medical care of patients and their relatives; the three-pronged implications of the study; the Company’s lifetime commitment to provide the most accurate testing; 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.