myPath Melanoma Test Shows 90% Accuracy in 2nd Trial, Company Reports at USCAP 2016

myPath Melanoma Test Shows 90% Accuracy in 2nd Trial, Company Reports at USCAP 2016

Myriad Genetics, Inc., recently released positive data from a second and pivotal clinical validation trial of its myPath Melanoma test in a poster presentation at the 2016 USCAP Annual Meeting in Seattle, Washington.

“There is significant emotional distress associated with a melanoma diagnosis and doctors want to provide their patients with accurate information,” Loren Clarke, MD, medical director of Myriad Genetic Laboratories, said in a press release. “We’re developing the myPath Melanoma test to help pathologists improve the diagnosis of melanoma, particularly for patients with difficult-to-diagnose skin lesions.”

Results from the validation trial, involving 736 patients, showed that the myPath Melanoma test differentiated between malignant melanoma and benign nevi with more than 90 percent accuracy, 91.5 percent sensitivity and 92.5 percent specificity. These results are consistent with those observed in the first validation trial in 437 patients, which showed a diagnostic accuracy of greater than 90 percent, and, the company said, demonstrate the ability of myPath Melanoma test to help diagnose cases of melanoma in samples representative of those seen in routine clinical practice.

The myPath Melanoma test measures 23 genes for which expression patterns differ between malignant melanoma and benign nevi. These genes are involved in cell differentiation, cell signaling, and immune response signaling.

“myPath Melanoma is an extremely robust diagnostic test with unmatched clinical validity data, having completed the largest clinical validation study for a melanoma diagnostic test,” Dr. Clarke said.  “We have now demonstrated in two pivotal validation studies that myPath Melanoma accurately differentiates patients with melanoma from those with benign moles.”

The poster was presented by Hillary Kimbrell, MD, from Myriad Genetic Laboratories, and titled, “An independent validation of a gene expression signature to differentiate malignant melanoma from benign melanocytic nevi.”

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