Myriad's myRisk Hereditary Cancer™ Test Improves Colon Cancer Testing by 60 Percent

October 7, 2013 at 7:05 AM EDT

SALT LAKE CITY, Oct. 7, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced new clinical data from a study with myRisk Hereditary Cancer, a 25-gene hereditary cancer panel, that showed a 60 percent increase in mutations detected in cancer predisposition genes in patients with a prior history of colon cancer and/or polyps. Myriad is presenting this clinical study and data from four other studies this week at the Collaborative Group of the Americas on Inherited Colorectal Cancer (CGA) Annual Meeting in Anaheim, Calif.

Patients with a family history of colon cancer also are vulnerable to other cancers including breast, ovarian, endometrial and stomach cancer. The detection of individuals with mutations associated with hereditary colon cancer greatly increases the chances of successful medical management in those at-risk individuals, which will save lives and reduce the downstream healthcare costs. Also, once a patient has been identified as carrying a deleterious mutation that patient's family members can be tested to determine if they have an increased risk of cancer.

"The new data presented at this year's CGA meeting is ground breaking and underscores the importance of using multi-gene panels when testing patients for hereditary colon cancer," said Richard J. Wenstrup, MD, chief medical officer of Myriad. "Importantly, the data suggest that the use of a 25-gene hereditary cancer panel significantly improved the detection of mutations and is a more efficient way for patients to receive appropriate medical management."

Below is a summary of the key data being presented at the CGA annual meeting.

Abstract: Germline Mutations Identified by a 25-Gene Panel in Patients Undergoing Lynch Syndrome Testing

This study evaluated the mutation prevalence among cases referred for Lynch Syndrome (LS), the most common genetic cause of colon cancer, using the myRisk Hereditary Cancer test, a 25-gene hereditary cancer panel. The study presents data from two cohorts representing a total of 1,133 patients diagnosed with colon cancer or colorectal polyps. The results demonstrated that 10 percent of patients had deleterious mutations in the traditional hereditary colon cancer genes, but an additional 6 percent had deleterious mutations in other genes. This represents a 60 percent increase in the number of patients detected with deleterious mutations in cancer predisposing genes

Abstract: Overlap between Lynch Syndrome and Hereditary Breast and Ovarian Cancer Syndrome among Family Histories in Patients Tested for Hereditary Cancer Syndromes

This study investigated the overlap of personal and family histories in hereditary breast and ovarian cancer (HBOC) and hereditary colon cancer in 9,000 patients. Results showed that among patients tested for HBOC, 6.9 percent also had family histories that meet the National Comprehensive Cancer Network (NCCN) criteria for hereditary colon cancer. In addition, 30 percent of patients tested for hereditary colon cancer also met NCCN criteria for HBOC. This analysis demonstrates the overlap among patients with a family history of hereditary breast cancer and those with a family history of colon cancer, suggesting that patients may benefit from multi-gene panels to better improve the diagnosis of hereditary cancer syndromes.

Abstract: MSI-High Histology Is a Predictive Risk Factor for Lynch Syndrome

The objective of this study was to better understand the prevalence of hereditary colon cancer mutations in patients who have abnormal histology, regardless of family history. Approximately 13.9 percent (57/410) of patients with abnormal histology had a deleterious mutation. Importantly, among the patients who tested positive for a deleterious mutation, 77.2 percent (44/57) would not have met Amsterdam II criteria based on personal or family history for hereditary colon cancer testing if histology was not considered. These data support the use of histology to simplify patient selection for hereditary colon cancer testing. 

Abstract: Mutation Breakdown and Variant Rates in Lynch Syndrome

The objective of this study was to examine the mutation breakdown among the five genes currently included in hereditary colon cancer testing. Also, the 2006 variant of uncertain significance (VUS) rate was compared to the 2013 VUS rate. Data from this study show that approximately 45 percent of positive hereditary colon cancer mutations were in MSH2, 36 percent in MLH1, 15 percent in MSH6, 4 percent in PMS2, and 0.8 percent in EPCAM. The VUS rate has declined significantly from 14 percent in 2006 to 5.8 percent in 2013. These results confirm that hereditary colon cancer testing has improved with the addition of new colon cancer predisposition genes, allowing for increased sensitivity, while the validated reclassification methods have decreased the VUS rate and improved the usefulness of hereditary colon cancer testing.

Abstract: Clinical Presentation of Monoallelic MUTYH Mutation Carriers in a Select Population

This study identified MYH carriers among patients being tested for hereditary colon cancer. Among the 419 MYH mutation carriers that were identified, 54.9 percent (230/419) had a personal history of cancer and/or polyps. 31 percent (130/419) had colon polyps but no colon cancer and 17.9 percent (75/419) had only colon cancer. 71 of the patients had two or more cancers. In this highly selected patient population, a higher frequency of colon cancer and polyps was observed compared to the general population. These data indicate that mutations in the MYH gene may increase an individual's risk of colon cancer.

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 portfolio of 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: and our social media channels: Twitter and Facebook.

Myriad, the Myriad logo, 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 myRisk Hereditary Cancer™ testing improving colon cancer testing; the suggestion that the use of a 25-gene hereditary cancer panel significantly improves the detection of mutations and is a more efficient way for patients to receive appropriate medical management; the suggestion that patients may benefit from multi-gene panels to better improve the diagnosis of hereditary cancer syndromes; the MYH carrier data indicating that mutations in the MYH gene may increase an individual's risk of colon cancer; 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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Source: Myriad Genetics, Inc.

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