NEW YORK (GenomeWeb) — Medicare contractor Palmetto GBA has issued a final local coverage determination (LCD) for Myriad Genetics' myPath Melanoma test, the firm announced today.
Myriad's 23-gene expression signature test helps doctors differentiate malignant from benign biopsies. Palmetto's MolDx program has agreed to cover myPath Melanoma for the "diagnosis or exclusion of melanoma" when a board-certified dermatopathologist orders it; when the biopsy can't be definitively classified as benign or malignant based on standard clinical and histopathological features; and when, the patient will to have to endure another biopsy because of this uncertain classification.
MyPath received a draft LCD last year. In order to determine coverage, MolDx reviewed several studies on the test's analytical and clinical validity, and clinical utility. In one prospective clinical validity study involving more than 700 samples, myPath had a sensitivity of 92 percent and specificity of 93 percent when compared to gold standard histopathological assessment.
According to Myriad, more than 1 million skin biopsies are performed annually and 15 percent of patients have equivocal skin lesions. "There is strong demand among physicians for an objective genetic test to be used as an adjunct to historical approaches for diagnosis,” said Loren Clarke, Myriad's medical director for dermatology, in a statement.
Myriad launched myPath Melanoma in 2013 and estimated at that time that the test had a global market opportunity of $800 million annually.