Myriad myPath(TM) Melanoma Improves Diagnosis and Treatment Plans

The gist: It can be difficult for doctors to tell whether a patient has malignant melanoma or simply a benign mole. A test called myPath Melanoma uses molecular testing to help clarify whether or not a person has melanoma. Researchers recently finished a study to look at the effectiveness of the test. They found that doctors who used MyPath Melanoma had 43% fewer cases of indecision, and changed their mind about treatment recommendations 49% of the time.

“Myriad Genetics, Inc. (Nasdaq:MYGN) today presented results from a prospective clinical utility study of its Myriad myPath Melanoma test at the 2014 American Society of Dermatopathology (ASDP) annual meeting in Chicago, Ill. Myriad myPath Melanoma is a genetic test that differentiates malignant melanoma from benign skin lesions across all major melanoma subtypes. Key findings of this clinical utility study included a 43 percent reduction in indeterminate diagnoses and a 49 percent change in physicians’ treatment recommendations for patients.

” ‘These findings demonstrate the power of Myriad myPath Melanoma to improve patient care through more definitive diagnoses of skin lesions, particularly in these difficult-to-call cases,’ said Loren Clarke, M.D., vice president of Medical Affairs at Myriad Genetic Laboratories. ‘Importantly, the number of indeterminate cases was significantly reduced, which means less uncertainty for more patients and physicians, and may lead to less overtreatment in these cases.’ ”

“The study evaluated the impact of the Myriad myPath Melanoma diagnostic test on dermatopathologists’ diagnoses and intended treatment recommendations for 218 patients with pigmented skin lesions that were considered difficult to diagnose. The dermatopathologists recorded their diagnoses and treatment plans before and after receiving the myPath Melanoma test results.”

Myriad Adds to Clinical Utility Data Backing Use of Melanoma Dx to Discern Malignant, Benign Lesions

The gist: Doctors sometimes perform molecular testing on patients’ tumors to identify certain characteristics that can inform treatment decisions. This article describes a molecular test called myPath Melanoma. It helps doctors determine is a patient’s skin lesion is malignant melanoma or benign. Recent research showed that myPath Melanoma helped doctors change their treatment decisions. In particular, many doctors opted for less intensive treatments for their patients based on myPath results.

Myriad Genetics this week presented data showing that its multi-gene myPath Melanoma test helped doctors change their treatment decisions, often lowering the intensity of the treatment strategy, for 35 percent of nearly 700 cases of pigmented skin lesions.

“Myriad presented the data, from a second clinical utility study for myPath Melanoma, at the College of American Pathologists’ annual meeting this week. The results of the prospective analysis aligned with findings from a retrospective clinical utility study presented earlier this year, which showed that doctors changed their decisions for 33 percent of cases using myPath Melanoma results.

“Myriad is marketing the 23-gene panel test, list priced at $1,500, as a tool that doctors can use to determine if a patient’s skin lesion is malignant melanoma or benign. Late last year the company provided early access to the test to dermatopathologists in the US through ‘The melEval Program.’ The test, according to Myriad, is one that pathologists can use to arrive at a more definitive diagnosis for suspicious, difficult-to-assess skin lesions. To date, approximately 120 dermatopathologists have submitted samples for testing with myPath through the early access program, according to the firm.

“In the latest prospective clinical utility study, 42 dermatopathologists answered questions about their treatment decisions for 687 cases of pigmented skin lesions, before and after performing the myPath Melanoma test. Myriad researchers asked these doctors to document their level of confidence about their diagnosis (is the skin lesion benign, malignant, or indeterminate) and their treatment recommendations before and after the test was performed.”