Myriad Genetics, Inc., has announced that results from a verification study show the Myriad myPath Melanoma test effectively differentiates malignant melanoma from benign skin lesions. The company believes that the clinically actionable information provided by myPath Melanoma will empower healthcare providers with objective data and improve the diagnosis of patients with melanoma. Approximately 14% of skin biopsies, company representatives say, are classified as indeterminate, leading to treatment dilemmas; it is hoped the new test will help pathologists confidently determine whether cells are benign or malignant.
The study evaluated a 23-gene panel designed to differentiate malignant melanoma from benign skin lesions. It analyzed 464 skin biopsy samples, including 254 representing melanomas from all major subtypes including superficial spreading, lentigo maligna melanoma, acral, nodular, and desmoplastic lesions. Using this set of patient samples, the test demonstrated high sensitivity of 89% and specificity of 93% 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,” says Sancy Leachman, MD, PhD, 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.” Learn more about products and services provided by Myriad.
