SALT LAKE CITY, June 2, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today presented results from a pivotal clinical validation study of the Myriad myPath™ Melanoma test at the 2014 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Ill. The Myriad myPath Melanoma test is a novel molecular test that accurately differentiates malignant melanoma from benign skin lesions with a high level of accuracy and helps physicians deliver a more objective and confident diagnosis for patients.
"Unfortunately, some melanomas mimic benign skin lesions, making them very difficult to diagnose and an uncertain result is confusing for patients and clinicians. What we need is a new tool to help us make a more definitive diagnosis," said Sancy Leachman, M.D., Ph.D, chair of the Department of Dermatology at the Oregon Health & Science University (OHSU) School of Medicine and director of the Melanoma Research Program at the Knight Cancer Institute. "In the validation study, Myriad myPath Melanoma was shown to differentiate malignant melanoma from benign skin lesions using traditional dermatopathology as a gold standard. This represents a significant contribution toward making a prompt and accurate diagnosis of potentially fatal melanoma."
The clinical validation study evaluated 437 pigmented lesions (211 melanomas and 226 nevi) representing a broad spectrum of subtypes submitted from four academic medical centers in the United States. The clinical endpoint was the concordance of the Myriad myPath Melanoma test to a consensus diagnosis from expert dermatopathologists. In this study, the Myriad myPath Melanoma test effectively differentiated malignant melanoma from benign skin lesions with a sensitivity of 90 percent and a specificity of 91 percent. These results strongly support the clinical use of the Myriad myPath Melanoma test as an adjunct to standard pathology techniques in the evaluation of pigmented skin lesions, particularly in difficult-to-classify cases.