Healthcare Industry News: BRCA1
News Release - December 12, 2013
Myriad myRisk Hereditary Cancer(TM) Test Significantly Improves Detection of Women at Risk for Hereditary Cancer by 51 PercentSALT LAKE CITY, Dec. 12, 2013 -- (Healthcare Sales & Marketing Network) -- Myriad Genetics, Inc. (MYGN) today presented clinical data at the 2013 San Antonio Breast Cancer Symposium that showed the myRisk Hereditary Cancer test found 51 percent more patients with a higher risk of hereditary breast and ovarian cancer than did testing for the BRCA1 and BRCA2 genes alone. myRisk is a new diagnostic test that uses next-generation sequencing technology to evaluate 25 genes associated with eight major hereditary cancers including: breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma.
This large prospective clinical validation study measured mutations in 25 cancer-causing genes among patients who were referred for BRCA1/2 testing. Among the 1,951 patients evaluated, 275 patients tested positive for a deleterious mutation with the myRisk test. Testing only for the BRCA1 and BRCA2 genes found only 182 of the mutation carriers, representing a 51 percent increase in hereditary breast and ovarian cancer mutation detection for the myRisk test. In this study, the accuracy of the myRisk test was 99.99 percent.
myRisk Hereditary Cancer has now been validated in approximately 5,000 patients in clinical studies. Today's results build on recently presented data that showed the myRisk test improved the detection of mutations in patients referred for hereditary colon cancer testing by 61 percent and with a 99.99 percent accuracy, which is equal to the gold standard Sanger DNA sequencing.
"Hereditary cancers are caused by mutations in many different genes and new genes linked to cancer have been recently identified. Testing only for one hereditary cancer syndrome may lead to missed mutations," said Richard J. Wenstrup, M.D., chief medical officer of Myriad. "The myRisk test evaluates 25 clinically actionable genes and significantly improves our ability to identify people at higher risk for hereditary cancer, which may lead to prevention or early detection with the ability to reduce cancer incidence and mortality."
The myRisk Hereditary Cancer test includes only clinically actionable genes. The majority of genes in the panel are reflected in the National Comprehensive Cancer Network (NCCN) guidelines and the clinical relevance of all 25 genes is well characterized in the peer-reviewed medical literature. Additionally, all genes in the myRisk panel have a high to moderately-high penetrance or lifetime risk of cancer for patients. For more information about hereditary cancer testing or myRisk, visit: www.myriad.com or take the hereditary cancer quiz at: www.hereditarycancerquiz.com.
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 at: www.myriad.com and our social media channels: Twitter and Facebook.
Myriad, the Myriad logo and myRisk are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries.
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 presentation of myRisk Hereditary Cancer clinical study data at the San Antonio Breast Cancer Symposium annual meeting; data showing increased sensitivity of the test results; the effectiveness of myRisk testing to accurately assess risk; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are management's present 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 described in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic 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; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our 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; 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 companion diagnostic 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 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.
Source: Myriad Genetics
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