Myriad Publishes myPath™ Melanoma Pivotal Validation Study in the Journal of Cutaneous Pathology

Mar 6 2015

Validated myPath Melanoma Test is 90 Percent Accurate in Diagnosis of Melanoma

Myriad Genetics, Inc. (NASDAQ: MYGN) today announced the Journal of Cutaneous Pathology published data from a pivotal clinical validation study that showed the myPath™ Melanoma test is highly effective at differentiating benign skin moles from malignant melanoma with greater than 90 percent diagnostic accuracy.  Melanoma is the most dangerous type of skin cancer and more than 76,000 new cases of melanoma are diagnosed each year in the United States.

“Conventional methods of differentiating benign moles from melanoma are effective for many cases, but there is no one-size-fits-all approach.  About 15 percent of cases are difficult or impossible to diagnose using standard tools, which can lead to undesirable outcomes such as untreated melanoma, unnecessary treatment or psychological distress,” said Loren Clarke, M.D., medical director for Dermatology at Myriad.  

myPath Melanoma is a powerful new molecular diagnostic test that analyzes genetic information inside skin cells to help us understand the biology of a patient’s skin lesion and objectively differentiate benign moles from potentially lethal melanoma

The published study describes the discovery, verification and clinical validation of the myPath Melanoma test, which was designed to differentiate benign moles from malignant melanoma.  The myPath Melanoma test was developed using a verification cohort of 464 patient samples and was validated in a separate independent study with 437 patient samples from leading academic medical centers in the United States.  In both the verification and validation studies, the myPath Melanoma test demonstrated a greater than 90 percent diagnostic accuracy, making it the most accurate molecular diagnostic test developed to date for melanoma.  These clinical findings validate the performance, objectivity and reliability of the myPath Melanoma test for clinical use to improve the diagnosis of melanoma.

“The myPath Melanoma study results confirm the test’s potential to more objectively differentiate between benign lesions and malignant melanoma than current evaluation practices,” said Sancy Leachman. M.D., Ph.D., one of the study’s lead investigators and director of the Melanoma Research Program, Knight Cancer Institute, Oregon Health & Science University.  “The study results validate the promise of molecular diagnostics in improving the precision of cancer treatment.”

About Myriad myPath Melanoma Testing

Myriad myPath Melanoma is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. Myriad myPath Melanoma is a unique test of 23 genes that provides valuable, additive diagnostic information unavailable from any other method – information that can help physicians deliver a more confident diagnosis.  

Melanoma is the most serious type of skin cancer. According to the American Cancer Society, about 76,000 new melanomas are diagnosed each year and more than 9,000 people die from the disease annually. Each year in the United States, there are approximately 1.5 million skin biopsies performed specifically for the diagnosis of melanoma, and approximately 15 percent, or 225,000 biopsies, are classified as indeterminate, meaning that the dermatopathologist cannot confidently determine whether the cells are benign or malignant.  For more information visit: http://www.isthismelanoma.com  and www.myriadpro.com/melanoma.