Myriad Genetics, Inc. (NASDAQ: MYGN) today announced it will highlight several new clinical studies on its myRisk Hereditary Cancer molecular diagnostic test at the 2015 American Society of Clinical Oncology annual meeting being held in Chicago, Ill.
The myRisk Hereditary Cancer test assesses 25 genes for mutations associated with eight hereditary cancers. Finding deleterious mutations in these genes can help patients with cancer receive appropriate medical care and reduce the risk of second cancers, while patients without cancer can take steps in consultation with their healthcare provider to lower their risk of developing cancer. “Myriad is pioneering a new era of cancer treatment and prevention. The myRisk Hereditary Cancer test has the potential to reduce the burden of hereditary cancer in the lives of women and men for generations to come,” said Richard Wenstrup, M.D., chief medical officer, Myriad. “myRisk represents a significant new opportunity to help physicians tailor treatment to individuals based on their genetic results as well as their personal and family history of cancer.” Below are the key myRisk Hereditary Cancer presentations being highlighted at #ASCO15.
Podium Presentation S100BC: Predisposing Germline Mutations in High Grade ER+HER2- Breast Cancer Patients Diagnosed <50 Years of Age.
Judy Garber, M.D., (Dana-Farber Cancer Institute), presented data on pathogenic DNA mutations in 106 high grade ER+ HER2- breast cancer patients diagnosed <50 years of age. A total of 25 cancer genes were assessed using the myRisk Hereditary Cancer test and germline mutations were classified for pathogenicity. The results demonstrated that 10.4 percent of women with ER+ HER2- breast cancer who were tested had a deleterious mutation. BRCA1/2 mutations were found in 6.6 percent of patients; however, mutations also were found in other genes related to breast cancer such as ATM, CHEK2, PALB2 in 4.7 percent of patients, representing a greater than 70 percent increase in patients identified with pathogenic mutations. These findings support expanded testing with myRisk Hereditary Cancer in women with Grade III ER+/HER2- breast cancer diagnosed at age <50, which will find more mutation carriers and has the potential to improve medical management decisions.
Poster 181: A Study of Triple Negative Breast Cancer Patients Tested with a 25-Gene Panel of Hereditary Cancer Genes.
John Sandbach, M.D. (Texas Oncology Austin), highlighted data on the distribution of mutations identified with the myRisk Hereditary Cancer 25-gene panel in 3,413 patients with triple negative breast cancer (TNBC) and compared those results to 22,890 patients with other types of breast cancer. The results found that the overall prevalence of mutations in patients with TNBC was 14.7 percent, compared to 9.2 percent in patients with other types of breast cancer. In all patients with breast cancer, the myRisk Hereditary Cancer test identified 100.8 percent more mutations than BRCA1/2 testing alone. The increase in mutations identified in patients with TNBC was 43.7 percent and 121.8 percent in patients with other types of breast cancer. TNBC mutation carriers were found to have a higher occurrence of BRCA1 mutations (50.3 percent) than patients with other breast cancers (18.2 percent). Additionally, BARD1, RAD51C and PALB2 were significantly more prevalent in patients with TNBC compared to other types of breast cancer, while ATM and CHEK2 were significantly less prevalent. These data provide insight into the prevalence and diversity of deleterious mutations that may drive the development of TNBC, and highlight the importance of a 25-gene panel versus BRCA1/2 testing alone, which may allow affected patients to receive more appropriate and tailored medical management.
Poster 338: Outcomes of Clinical Testing for 76,000 Patients Utilizing a Panel of 25 Genes Associated with Increased Risk for Breast, Ovarian, Colorectal, Endometrial, Gastric, Pancreatic, Melanoma and Prostate Cancers.
Eric Rosenthal, Ph.D. (Myriad Genetic Laboratories) presented outcomes data from clinical testing of a large, diverse cohort of U.S. patients using the myRisk Hereditary Cancer test. Results are included from the first 76,564 patients tested with the myRisk Hereditary Cancer 25-gene panel. The data found that 7.4 percent of the patients tested carry one or more deleterious mutations linked to an increased risk for hereditary cancer. Importantly, in this analysis the myRisk Hereditary Cancer test resulted in a 130 percent increase in the number of individuals identified with an increased risk for inherited cancer compared with BRCA1/2 testing alone. A significant number of total mutations were found in patients with no personal or family history of cancer associated with that specific gene, suggesting panel testing identifies genetic mutations not apparent from personal and family history alone. Additionally, deleterious mutations were found in patients of all ancestries, indicating that the myRisk Hereditary Cancer test can increase mutation detection across ethnic populations. These findings may benefit patients carrying deleterious mutations in genes for which testing was not widely available previously, and/or whose personal/family histories do not fit unambiguously with a single cancer syndrome.
Poster 357: Multi-Gene Panel Testing in an Unselected Endometrial Cancer Cohort.
Kari Ring, M.D., (MD Anderson Cancer Center) presented data on the prevalence of germline mutations in Lynch Syndrome (LS) and other cancer predisposition genes in 381 patients with endometrial cancer. DNA mutations in 25 cancer genes were identified using the myRisk Hereditary Cancer test. The data showed that 35 patients (9.2 percent) had a deleterious mutation. Of these, 22 patients (5.8 percent) had a deleterious mutation in LS genes and 13 patients (3.4 percent) had a deleterious mutation in non-LS genes, which represents a 59 percent increase in the number of patients identified with mutations using myRisk. Results for endometrial cancer with a deleterious mutation in LS genes were similar to previous findings. Using the myRisk Hereditary Cancer panel test to include non-LS genes allowed for the identification of additional genes that may be associated with serous-type endometrial cancer, the most clinically aggressive form of this cancer. These data are consistent with recent National Comprehensive Cancer Network (NCCN) guideline updates and support providing hereditary cancer testing for the approximately 50,000 patients diagnosed each year with endometrial cancer.
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: http://www.myriad.com/products-services/hereditary-cancers/myrisk-hereditary-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 is focused on strategic initiatives to grow existing markets, diversify through the introduction of new products, including companion diagnostics, and expand 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, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, HRD, Vectra 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 myRisk Hereditary Cancer test having the potential to reduce the burden of hereditary cancer in the lives of women and men for generations to come; the Garber study data supporting expanded testing with myRisk Hereditary Cancer in women with Grade III ER+/HER2- breast cancer diagnosed at age <50, and such expanded testing finding more mutation carriers and having the potential to improve medical management decisions; the Ring study data supporting providing hereditary cancer testing for the approximately 50,000 patients diagnosed each year with endometrial cancer; 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 molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing to new testing services, including unexpected costs and delays; risks related to decisions or 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; risks related to increased competition and the development of new competing tests and services; 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 licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services 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 our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products 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 or other intellectual property; 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 of in our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2014, which has been 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.
Myriad Genetics, Inc.
2015 American Society of Clinical Oncology annual meeting