SALT LAKE CITY, Utah, Dec. 9, 2015 - Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and personalized medicine, today announced it will highlight three scientific presentations related to its myRisk Hereditary Cancer test at the 2015 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. Data include results from studies that advance the understanding of hereditary cancer testing using multi-gene panels to evaluate patients at risk for or diagnosed with breast cancer.
"Our collaborators will present data at SABCS this year that show multi-gene panel testing with myRisk Hereditary Cancer provides clinically significant results that drive appropriate changes in patient care," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "Importantly, there are new data that demonstrate the positive perceptions from patients after they receive a multi-gene test result. Furthermore, as we expand our testing to broader gene panels and share scientific outcomes from our research collaborations, important new questions are being asked that will expand our thinking about exactly which patients should be tested for hereditary cancer."
Details about the featured myRisk Hereditary Cancer presentations at SABCS are below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS15.
myRisk Hereditary Cancer Poster Presentations
- Title: Interim analysis of multiplex gene panel testing for inherited susceptibility to breast cancer.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-01.
Presenter: Dr. Gregory Idos, Stanford University Cancer Institute.
This multi-center prospective study was designed to analyze data from 2,000 patients undergoing cancer-risk assessment using the myRisk Hereditary Cancer 25-gene panel test. The objective was to determine the benefits of multi-gene panel testing versus traditional genetic testing. The interim analysis of the first 332 patients tested found that 11 percent were positive for a deleterious mutation. Among participants testing negative for BRCA1 and BRCA2 mutations, the myRisk test identified deleterious mutations in 14 patients, representing a 61 percent increase over BRCA testing alone and prompting clinically appropriate risk reduction recommendations and enhanced cancer surveillance. These findings demonstrate the ability of the myRisk Hereditary Cancer test to identify a subset of patients with deleterious mutations who historically would have been missed by traditional genetic testing for BRCA1/2 alone, and who could receive appropriate medical management as a result.
- Title: The patient experience in a prospective trial of multiple-gene panel testing for cancer risk.
Date: Thursday, Dec.10, 2015: 7:30 to 9:00 a.m. CT.
Location: Poster P2-09-07.
Presenter: Dr. Allison Kurian, Stanford University Cancer Institute
In this study, 2,000 diverse patients at risk for hereditary breast/ovarian cancer syndrome were evaluated to determine the patient experience following genetic testing with the myRisk Hereditary Cancer test. Patients were surveyed at entry and three months after testing using the Multidimensional Impact of Cancer Risk Assessment (MICRA) scale. An interim analysis of the first 332 patients found that 87 percent said they did not regret learning about the results and 81 percent wanted all their genetic test results for all 25 genes tested. Although the study is ongoing, these interim results suggest there is no evidence of an increase in cancer- or testing-related distress/uncertainty after patients received their test results.
- Title: Predisposing germline mutations in an unselected academic breast cancer (BC) cohort.
Date: Wednesday, Dec. 9, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P1-08-07.
Presenter: Dr. Judy Garber, Dana-Farber Cancer Institute
In this study, 456 patients newly diagnosed with breast cancer were evaluated for mutations in 25 cancer genes using the myRisk Hereditary Cancer test. The results show that 11 percent of the patients in a single academic institution had a germline mutation in a breast cancer predisposition gene. Approximately 7 percent were in BRCA1/2 genes and 4 percent were in other cancer genes. Of the 49 women with deleterious mutations associated with breast cancer, 21 (43 percent) were diagnosed after age 45. This finding suggests that patients diagnosed with breast cancer at older ages may benefit from genetic testing with the myRisk Hereditary Cancer gene panel test.
For more information about these presentations, please visit the SABCS website at https://www.sabcs.org/.
About Myriad myRisk™ Hereditary Cancer Testing
The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology 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: http://www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, 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 clinical utility of the Myriad myRisk™ Hereditary cancer gene panel test; multi-gene panel testing with myRisk Hereditary Cancer providing clinically significant results that drive appropriate changes in patient care; new data demonstrating positive perceptions from patients after they receive a multi-gene test result; the ability of the myRisk Hereditary Cancer test to identify a subset of patients with deleterious mutations who historically would have been missed by traditional genetic testing for BRCA1/2 genes alone, and who could receive appropriate medical management as a result; the findings of the studies suggesting that patients diagnosed with breast cancer at older ages may benefit from genetic testing with the myRisk Hereditary Cancer gene panel test; the Company's commitment to bringing transformative molecular diagnostics to people with cancer; 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.