Myriad myRisk® Hereditary Cancer Test Demonstrates the Magnitude of Breast and Ovarian Cancer Risk in Nearly 100,000 Patients
SALT LAKE CITY, June 06, 2016 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that two analyses demonstrating the utility of the Myriad myRisk® Hereditary Cancer test will be featured in oral presentations at the 2016 American Society of Clinical Oncology annual meeting. These presentations demonstrate the importance of using a 25-gene panel to evaluate risk for hereditary breast and ovarian cancers.
"Risk assessment for hereditary cancer is expanding with the use of the myRisk Hereditary Cancer 25-gene panel, approximately doubling the rate of mutation detection over BRCA1/2 testing alone. However, in these studies we sought to understand the magnitude of risk across 25 genes," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "We discovered that mutations in eight genes are associated with a two- to six-fold increase in breast cancer risk and mutations in 11 genes confer a two- to 40-fold increased risk for ovarian cancer. These important findings clarify the risk across diverse genes and support the use of myRisk as part of a clinical risk assessment for patients."
Results of the studies to be presented are described below and abstracts are available at: abstracts.asco.org. Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.
myRisk Hereditary Cancer Podium Presentations
Title: Magnitude of invasive breast cancer (BC) risk associated with mutations detected by multiple-gene germline sequencing in 95,561 women.
Presenter: Michael Hall, Stanford University Cancer Institute
Date: Monday, June 6, 2016, 8:00 — 11:30 a.m.; Discussion 1:15 — 2:30 p.m.
Location: S404, Abstract 1512, Poster Board 335
This study evaluated the magnitude of invasive breast cancer (BC) risk associated with mutations across a 25-gene panel test. A total of 95,561 patients underwent clinical testing with the myRisk Hereditary Cancer test. Seven percent of patients tested positive for a deleterious mutation. The majority of mutations occurred in BRCA1/2 genes (44 percent) or other genes associated with BC risk (40 percent). There was a significant association with personal BC history and mutations in BRCA1/2, PTEN, TP53, PALB2, CHEK2, BARD1 and ATM. Specifically, estimates ranged from two (ATM, CHEK2, BARD1) to six (BRCA1, PTEN) times increased risk for breast cancer. These findings demonstrate the BC risk across the diverse panel of 25 genes in the myRisk test.
Title: Ovarian cancer risk associated with mutations detected by multiple-gene germline sequencing in 95,561 women.
Presenter: Allison Kurian, Stanford University Cancer Institute
Date: Monday, June 6, 2016, 9:45 — 11:15 a.m.
Location: E450ab, Abstract: 5510
This study evaluated the magnitude of ovarian cancer (OC) risk with mutations across the 25 genes included in the myRisk Hereditary Cancer panel. Data from 95,561 patients were analyzed to examine the association between deleterious mutations and personal history of OC. The results showed that seven percent of patients tested positive for a deleterious mutation. Among 5,020 women affected by OC, 14 percent had a deleterious mutation (63 percent with BRCA1/2, 9.4 percent in Lynch Syndrome genes and 11.2 percent in other genes associated with OC). In this study, 11 genes were associated with a significant risk of OC, including the first report of OC risk associated with the ATM gene. Importantly, one-third of mutations in patients with OC were in non-BRCA and non-Lynch genes, demonstrating that panel testing with the myRisk test identified a broader spectrum of associated cancers.
About Myriad myRisk® Hereditary Cancer Testing
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms in an 850 step laboratory process to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: https://www.myriad.com/products-services/hereditary-cancers/myrisk-hereditary-cancer/.
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 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: 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, Vectra 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 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 presentation of data from two clinical studies at the 2016 American Society of Clinical Oncology annual meeting to be held June 3-7, 2016 in Chicago, Ill; key podium presentations highlighting the safety and validity of the myRisk Hereditary multigene panel test in assessing hereditary cancer risk; the myRisk Hereditary Cancer studies presented at ASCO advancing the state-of-the-art of hereditary cancer testing; the new data providing additional evidence for the safety and clinical utility of the myRisk Hereditary Cancer test to help improve and save the lives of patients; 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; 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, 2015, 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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