Myriad's myRisk Hereditary Cancer™ Test Improves Colon Cancer Testing by 60 Percent
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
Below is a summary of the key data being presented at the CGA annual meeting.
Abstract: Germline Mutations Identified by a 25-
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.
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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
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