Melanoma Diagnostic Distinguishes Between Malignant and Benign Skin Lesions

A new diagnostic test effectively differentiates malignant melanoma from benign pigmented skin lesions. It is designed specifically for difficult to diagnose melanoma cases.

The test called myPath Melanoma was launched by Myriad Genetics, Inc. (Salt Lake City, UT, USA). The diagnostic test will deliver valuable, diagnostic information unavailable from any other test—information that can help physicians provide a more informed diagnosis.

Myriad myPath Melanoma is being launched in a phased approach beginning with an early-access program called the melEval Program that will introduce the test to leading dermatopathologists across the country. myPath Melanoma will be sold through a dedicated specialty sales force from Myriad and has average selling price of USD 100.

The myPath Melanoma test has been extensively investigated in two independent clinical studies. Myriad recently presented its verification study results at the American Society of Dermatopathology annual meeting, which was held on October 10, 2013, in the Washington Marriott Wardman Park in Washington DC (USA).

These data showed that the myPath Melanoma test demonstrated over 90% accuracy in differentiating malignant melanoma from benign skin lesions in a variety of subtypes. Results have recently been confirmed in an independent clinical validation study that will be presented at the American Academy of Dermatology in March 2014 in the American Academy of Dermatology's Annual Meeting, which will be held in Denver (CO, USA), March 21–25, 2014.

"Even with years of clinical experience, pathologists still have cases where a definitive diagnosis is uncertain. 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," said Mark C. Capone, president of Myriad Genetic Laboratories. "Myriad myPath Melanoma is designed for these difficult-to-diagnose cases and will provide healthcare providers with objective data that will improve the diagnosis of patients with suspicious skin lesions."

Myriad myPath Melanoma is the third molecular diagnostic test launched by Myriad this fiscal year. In October, the Company launched Myriad myPlan for Lung Cancer, a new prognostic test for patients diagnosed with early-stage lung cancer. In September, the Company launched Myriad myRisk Hereditary Cancer, a new multi-gene diagnostic test for eight major hereditary cancers including breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric, and melanoma.

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Myriad Genetics
myPath Melanoma