Pivotal clinical validation data presented at the 50th ASCO Annual Meeting
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.
The Myriad myPath Melanoma test has now shown reproducible results in two large cohorts. Last November, Myriad presented results from its verification study at the American Society of Dermatopathology annual meeting. Data from that verification study of 464 lesions showed that the Myriad myPath Melanoma test had greater than a 90 percent diagnostic accuracy in differentiating malignant melanoma from benign skin lesions in a variety of subtypes.
Additionally, an analysis of a prospective clinical utility study was highlighted at ASCO and initial findings from that study are consistent with earlier findings from a retrospective clinical utility study that was presented at the United States & Canadian Academy of Pathology's (USCAP) annual meeting in March. The USCAP data demonstrated a 33 percent change in medical management based upon the Myriad myPath Melanoma test result.
"We believe the Myriad myPath Melanoma test will substantially improve the standard of care for patients with melanoma," said Loren Clarke, M.D., vice president of Medical Affairs at Myriad Genetic Laboratories. "The Myriad myPath Melanoma test objectively answers a vital clinical question for healthcare providers: Does my patient have malignant melanoma that requires surgical or medical intervention, or a harmless skin lesion that only needs to be watched? The appropriate therapy may differ drastically depending on the answer to that question."
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