×

Myriad Publishes myRisk Hereditary Cancer Study in Cancer

SALT LAKE CITY, Sept. 3, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN), today announced that the Myriad myRisk Hereditary Cancer test significantly improved the detection of cancer-causing mutations by 46 percent in patients with breast cancer in a new study published in the journal Cancer (http://onlinelibrary.wiley.com/doi/10.1002/cncr.29010/abstract).

In this study, researchers at Beth Israel Deaconess Medical Center, Dana Farber Cancer Institute and Massachusetts General Hospital Cancer Center used the myRisk test to determine the frequency of hereditary cancer mutations in 2,158 individuals with a history of breast cancer, including 1,781 referred for commercial BRCA1/2 testing, and 377 patients with a personal and family history who previously tested negative for BRCA mutations.

Deleterious mutations were found in a total of 16 genes. Among the 1,781 patients referred for commercial BRCA testing, 9.3 percent carried a mutation in BRCA1 or BRCA2. Importantly, an additional 4 percent of patients carried a mutation in another breast and ovarian cancer susceptibility gene. Among the 377 patients with personal and family histories who previously tested negative for BRCA mutations, the frequency of mutations in the other breast and ovarian cancer susceptibility genes was nearly 3 percent. Additionally, among the 1,781 patients referred for commercial BRCA testing, 0.4 percent of individuals had mutations in colon cancer (Lynch-syndrome) genes.

The myRisk Hereditary Cancer test increased the detection of cancer-causing mutations in genes other than BRCA1 or BRCA2 by 46 percent and found 43 percent more women with a deleterious mutation. Most of these new mutations were in other cancer susceptibility genes associated with breast/ovarian cancer such as CHEK2, PALB2 and ATM.

"In this study, the Myriad myRisk Hereditary Cancer test identified significantly more genetic mutations that raise the risk of hereditary breast, ovarian, and other cancers," said Nadine Tung, M.D., director, Cancer Risk and Prevention Program, Beth Israel Deaconess Medical Center. "These findings support the use of panel testing for some patients with breast cancer because it is much more efficient than testing one gene at a time, and may identify mutations in patients who are unaware of their family history of cancer. Patients should discuss their test results with a qualified healthcare professional and once they know their risk, they can take appropriate action to better manage their healthcare."

The myRisk test uses powerful next-generation sequencing technology to evaluate 25 clinically significant genes associated with eight cancers to provide patients with information about their cancer risks.

"The myRisk test is rapidly moving us beyond testing for one gene at a time, making it possible to test multiple cancer-causing genes at once, which we believe will significantly improve patient care in this new era of genomic medicine," said Anne-Renee Hartman, M.D., vice president of Clinical Development at Myriad Genetic Laboratories. "Myriad is committed to advancing the science even further, and we are conducting several additional studies to develop evidence-based approaches to cancer prevention and risk reduction in these patients."

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/myrisk-hereditary-cancer-panel/.

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. 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, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, HRD, Vectra DA and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. 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 relating to the importance and clinical significance of our myRisk Hereditary Cancer test; 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 existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to changes in the 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; 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 we may not be successful in transitioning from our existing product portfolio to our new products, such as our myRisk Hereditary Cancer test, which represents the next generation of our existing hereditary cancer franchise; the risk that we may not be able to generate sufficient revenue from our existing tests and our new tests or develop new tests; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; 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 increased competition and the development of new competing tests and services; risks related to our projections about the potential market opportunity for our products; 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; 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 in our most recent Annual Report on Form 10-K 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.

CONTACT: Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com

Source:Myriad Genetics, Inc.