SALT LAKE CITY, Oct. 14, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that results from a verification study showed the Myriad myPath™ Melanoma test effectively differentiated malignant melanoma from benign skin lesions. The clinically-actionable information provided by myPath Melanoma will empower healthcare providers with objective data and improve the diagnosis of patients with melanoma. Myriad presented these data at the American Society of Dermatopathology Annual Meeting on Oct. 13, 2013.
The verification study evaluated a 23-gene panel designed to differentiate malignant melanoma from benign skin lesions. The study analyzed 464 skin biopsy samples including 254 samples representing melanomas from all major subtypes including superficial spreading, lentigo maligna melanoma, acral, nodular and desmoplastic lesions. Using this set of patient samples, the myPath Melanoma test demonstrated high sensitivity of 89 percent and specificity of 93 percent at differentiating malignant melanoma from benign skin lesions.
"The data from this large cohort showed that this test is highly accurate, relative to expert dermatopathologic review, at differentiating malignant melanoma from benign skin lesions," said Sancy Leachman, M.D., Ph.D, chair of the Department of Dermatology in the Oregon Health & Science University (OHSU) School of Medicine and director of the Melanoma Research Program at the Knight Cancer Institute. "The diagnosis of melanoma by conventional methods often is subjective, and this test provides objective data which could make it an extremely valuable and useful diagnostic tool to help save patients' lives."
Melanoma is the most serious type of skin cancer. According to the American Cancer Society statistics, about 76,000 new melanomas are diagnosed each year, and more than 9,000 people die from melanoma annually. Each year in the United States, there are approximately two million skin biopsies performed specifically for the diagnosis of melanoma. Approximately 14 percent or 280,000 biopsies are classified as indeterminate, which means the dermatopathologist cannot confidently determine whether the cells are benign or malignant.
"Patients and physicians with an indeterminate biopsy result face the challenging clinical question of whether to treat the lesion as melanoma or risk not treating a potentially fatal cancer," Loren Clarke, M.D., vice president of Medical Affairs of Dermatology at Myriad. "Late-stage melanoma has a five-year survival rate of 15 percent compared to early-stage melanomas that have five-year survival rates of about 90 percent. The ability to accurately diagnose and treat melanoma early on is critical to obtaining favorable long-term clinical outcomes."
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: www.myriad.com and our social media channels: Twitter and Facebook.
Myriad, the Myriad logo and myPath are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and other 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 myPath Melanoma providing clinically-actionable information that will empower healthcare providers with objective data and improve the diagnosis of patients with melanoma; myPath Melanoma providing objective data which could make it an extremely valuable and useful diagnostic tool to help save patients' lives; 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.