Molecular diagnostic company Myriad Genetics recently presented the results of its pivotal clinical utility study of the Myriad myPath Melanoma test, a new diagnostic tool for determining if a tissue is a malignant melanoma or a benign skin lesion, at the 2014 College of American Pathologists (CAP) annual meeting in Chicago, Illinois. The test is 90 percent accurate and may help physicians perform a more objective diagnosis.
The study conducted by Myriad Genetics was meant to assess the test’s impact on expert dermatopathologists’ diagnoses and treatment recommendations for patients. The trial included 687 patients suffering from pigmented skin lesions submitted by 42 dermatopathologists in the United States. As part of the study, the experts registered their level of confidence, any further testing and recommendations for treatment, and a diagnosis, both before and after knowing the myPath test results.
According to the results of the study, 35% of the dermatopathologists revised their treatment recommendations after seeing the myPath Melanoma test scores, and it led to 76 percent reduction in “indeterminate” diagnoses. The company believes that the study results reveal the positive outcomes of the test integration 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,” explained the vice president of Medical Affairs at Myriad Genetic Laboratories, Loren Clarke, M.D. “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?”
Myriad’s myPath Melanoma test performs a gene expression evaluation, analyzing 23 genes that provides valuable, additive diagnostics in order to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. The company has also recently presented the results of its pivotal clinical validation study at the 2014 American Society of Clinical Oncology (ASCO) annual meeting, also in Chicago.