Myriad Genetics launches diagnostic test for detecting melanoma

Myriad Genetics has launched its new diagnostic test to differentiate malignant melanoma from benign pigmented skin lesions.

Two independent clinical studies have investigated the Myriad myPath Melanoma test. Data from a verification study showed that the 23-gene panel demonstrated greater than 90% accuracy in a variety of subtypes of differentiating malignant melanoma from benign skin lesions. The research was presented at the American Society of Dermatopathology annual meeting last month in Washington, according to the press release.

Results of an independent clinical validation study will be presented at the American Academy of Dermatology annual meeting in March in Denver, Myriad said.

“Even with years of clinical experience, pathologists still have cases where a definitive diagnosis is uncertain,” Mark C. Capone, president of Myriad Genetic Laboratories, said in the release. “In these cases, patients and physicians face the difficult question of whether to treat the lesion as melanoma or risk not treating a potentially fatal cancer. Myriad myPath Melanoma is designed for these difficult-to-diagnose cases.”

An early-access program called the melEval Program will be used to introduce the test to leading dermatopathologists, and the product will be sold through a specialty sales force, the release said.