Myriad myPath(TM) Melanoma Improves Diagnosis and Treatment Plans
Source: GlobalNewsWire, November 2014
New Prospective Clinical Utility Data Presented at the ASDP Annual Meeting
Myriad Genetics, Inc. 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. The changes in patient diagnoses are summarized in the table below.
| Pathology Diagnosis | Pre-Test (N=218) | Post-Test (N=218) | % Change |
| Benign | 10.6% | 40.8% | +30.2% |
| Malignant | 9.2% | 21.6% | +12.4% |
| Indeterminate | 80.3% | 37.6% | – 42.7% |
The dermatopathologists also were asked how the Myriad myPath Melanoma test result would change their intended treatment recommendations for patients. Overall, changes in treatment recommendations were observed in 49.1 percent of difficult-to-diagnose cases. In 39.4 percent of patients receiving a benign test result, recommendations were downgraded to less invasive treatment. Conversely, in 45.8 percent of patients receiving a malignant test result, recommendations were upgraded to more invasive treatment.
“These data strongly support the integration of the Myriad myPath Melanoma test into clinical practice to personalize and improve patient care," said Clarke. “The Myriad myPath Melanoma test objectively answers a vital clinical question for physicians: Does my patient have malignant melanoma that requires aggressive intervention, or a harmless skin lesion that should be monitored?"
About Myriad myPath Melanoma
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 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 14 percent 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.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients’ lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad’s molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual’s decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G