Myriad Genetics, Inc. presented results from a pivotal clinical utility study of the Myriad myPath™ Melanoma test at the 2014 College of American Pathologists (CAP) annual meeting in Chicago, Ill. Myriad myPath Melanoma is a novel diagnostic test that differentiates malignant melanoma from benign skin lesions with greater than 90 percent accuracy and helps physicians deliver a more objective and confident diagnosis for patients.
This study evaluated the impact of the myPath Melanoma diagnostic test on expert dermatopathologists' diagnoses and treatment recommendations for patients. The analysis included 687 cases of pigmented skin lesions submitted by 42 leading dermatopathologists in the United States. These melanoma experts were asked to document their diagnosis, level of confidence, any further testing and recommendations for treatment both before and after receiving the myPath test results.
The results show that when the myPath Melanoma test score was provided to the dermatopathologists, they revised their treatment recommendations in 35 percent of cases. Additionally, the myPath test score led to a 76 percent reduction in "indeterminate" diagnoses. These data strongly support the integration of myPath Melanoma into clinical practice to improve the diagnosis of melanoma and enhance patient care.
"This clinical utility study demonstrates how the myPath Melanoma test can be successfully incorporated into clinical care to improve the treatment of malignant melanoma," said Loren Clarke, M.D., vice president of Medical Affairs at Myriad Genetic Laboratories. "Myriad myPath Melanoma provides objective information to answer an important clinical question: Does my patient have a melanoma that requires surgery or medical intervention or is the lesion a harmless mole that needs to be watched?"
About Myriad myPath Melanoma Testing
The Myriad myPath Melanoma test is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. The Myriad myPath Melanoma test 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.