New Test Improves Reliability of Melanoma Diagnosis

New results support the use of a novel multigene test as an important adjunct to standard pathology techniques in the evaluation of potentially malignant pigmented skin lesions.

Myriad Genetics, Inc. (Salt Lake City, UT, USA) has presented results from a pivotal clinical validation study of the "Myriad myPath Melanoma" test at the 50th annual meeting of the American Society of Clinical Oncology (ASCO; Chicago, IL, USA) May 30–June 3, 2014. myPath is a novel molecular test that differentiates malignant melanoma from benign skin lesions with a high level of accuracy and helps physicians deliver a more objective and more confident diagnosis for patients. It is a unique gene expression test of 23 genes that provides valuable, additive diagnostic information unavailable from any other method.

"We believe the Myriad myPath Melanoma test will substantially improve the standard of care for patients with melanoma," said Loren Clarke, MD, vice president of Medical Affairs at Myriad Genetic Laboratories. "Unfortunately, some melanomas mimic benign skin lesions, making them very difficult to diagnose," said Sancy Leachman, MD, PhD, chair of the Department of Dermatology at the Oregon Health & Science University (OHSU) School of Medicine and director of the Melanoma Research Program at the Knight Cancer Institute. myPath "represents a significant contribution toward making a prompt and accurate diagnosis of potentially fatal melanoma," she added.

The study evaluated 437 pigmented lesions (211 melanomas and 226 nevi) representing a broad spectrum of subtypes submitted from four academic medical centers in the USA. The clinical endpoint was the concordance of the myPath test to a consensus diagnosis from expert dermatopathologists. myPath effectively differentiated malignant melanoma from benign skin lesions with a sensitivity of 90% and specificity of 91%. These results strongly support the clinical use of the myPath as an adjunct to standard pathology techniques, particularly in difficult-to-classify cases.

The Myriad myPath Melanoma test has now shown reproducible results in 2 large cohorts, including data from a previous verification study of 464 lesions showing that myPath had greater than 90% diagnostic accuracy in differentiating malignant melanoma from benign skin lesions in a variety of subtypes. Additionally, initial findings of a prospective clinical utility study highlighted at ASCO are consistent with earlier findings from a retrospective clinical utility study showing a 33% change in medical management based on myPath testing.

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