SALT LAKE CITY, Utah, June 2, 2014 – Myriad Genetics, Inc. (Nasdaq: MYGN) today presented several clinical studies on the Myriad myRisk™ Hereditary Cancer test at the 2014 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois. Among the important new findings is that the myRisk test detects significantly more deleterious mutations than single cancer tests and helps solve the overlap dilemma that exists among hereditary cancer syndromes.
"There is robust evidence that hereditary cancers are caused by mutations in many genes and testing for only one hereditary cancer syndrome may lead to missed mutations," said Richard J. Wenstrup, M.D., chief medical officer of Myriad. "The Myriad myRisk test solves this dilemma by evaluating 25 clinically significant genes, which detects more deleterious mutations and people at risk for hereditary cancers."
The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant hereditary cancer genes associated with eight major hereditary cancers including: breast, colon, ovarian, endometrial, pancreatic, prostate, gastric cancers and melanoma. The myRisk test results are combined with a patient's personal and family history of cancer and medical society guidelines into a single comprehensive report for the physician, which makes it easier for physicians to tailor treatment plans for patients depending on their level of risk. A summary of the key Myriad studies featured at ASCO follows.
Multi-gene panel testing in patients suspected to have Lynch syndrome
Matthew Yurgelun. (Podium Presentation; S100a).
This study evaluated the outcomes of testing with the myRisk test in 1,260 patients with a history of hereditary colon cancer. Results show that 27 percent of mutation carriers identified by the myRisk test had mutations in genes not normally associated with hereditary colon cancer. Importantly, more than one third of the additional mutations found were in the BRCA1 and BRCA2 genes, which further demonstrates the overlap that exists between the hereditary breast and colon cancer syndromes.
A study of ovarian cancer patients tested with a 25-gene panel of hereditary cancer genes. Lucy Langer. (Podium Presentation; Location S100a)
Results from this study of 648 patients show that 15.4 percent of patients with ovarian cancer had a mutation that was detected by the Myriad myRisk Hereditary Cancer 25-gene panel. Of these, 59.6% percent of patients had mutations in BRCA1 and BRCA2, 34.6% had mutations in the other hereditary cancer genes in the panel, including hereditary colon cancer genes Testing patients with the myRisk Hereditary Cancer panel increased the number of positive test results in ovarian cancer patients by 63 percent over BRCA1 and BRCA2 testing alone.
Analysis of patients with two hereditary cancers (breast/ovarian or colon/endometrial) who met NCCN genetic testing criteria after their first cancer. Jennifer Saam (Poster 1542).
In this study, patients with a history of two associated cancers were evaluated to determine what percentage of patients met National Comprehensive Cancer Network (NCCN) criteria for genetic testing after their first cancer diagnosis, but who did not receive a test result until after their second cancer diagnosis. The majority of patients in this study had at least 5 years between their first and second cancers. For 9,982 patients with breast and ovarian cancer who were evaluated, the overall rate of BRCA1 and BRCA2 mutations was 22 percent. Of these, only 56 percent of patients diagnosed with breast and ovarian cancer met the NCCN criteria for genetic testing after their first cancer. Among 941 patients with colon and endometrial cancer who were evaluated, 28 percent had mutations in the genes associated with hereditary colon cancer. Of these, 65 percent of patients met NCCN criteria for genetic testing after their first cancer. These findings underscore the importance of diagnosing patients with hereditary cancer syndromes after their first cancer so that a second cancer can be prevented or identified early.
About Myriad myRisk Hereditary Cancer Testing
Myriad's myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant hereditary cancer genes associated with eight major hereditary cancers including: breast, colon, ovarian, endometrial, pancreatic, prostate, gastric cancers and melanoma.
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: http://www.myriad.com. Myriad, the Myriad logo, Prolaris, Myriad myPath, Myriad myPlan and Myriad myRisk 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 presentation of the Myriad myRisk Hereditary Cancer clinical study data at the 2014 ASCO Annual Meeting; the ability of the Myriad myRisk test to detect significantly more deleterious mutations than single gene tests and help to solve the overlap dilemma that exists among hereditary cancer syndromes; 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.
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