Malignant melanoma was differentiated from benign skin lesions with greater than 90% accuracy in a pivotal clinical utility study of the Myriad myPath Melanoma test. These results were presented at the 2014 College of American Pathologists annual meeting in Chicago, Illinois.
The study evaluated the impact of this diagnostic test on the diagnoses and treatment recommendations expert dermatopathologists made for their 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% of cases. In addition, the myPath test score led to a 76% 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, MD, 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?”