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Fly News Breaks for April 5, 2017
MYGN
Apr 5, 2017 | 07:21 EDT
Myriad Genetics has published the third clinical validation study and second clinical utility study for its myPath Melanoma test, which completes the reimbursement dossier for the product. The company will submit the reimbursement dossier to Medicare and private insurers three months earlier than expected. myPath Melanoma is an objective genetic test that measures 23 genes to help differentiate malignant melanoma from benign lesions. The third clinical validation was published in the journal Cancer Epidemiology, Biomarkers & Prevention. The study assessed the performance of the myPath Melanoma test in an independent cohort of 182 patients with melanocytic lesions against clinically proven outcomes. The results showed that the myPath Melanoma test had an overall diagnostic accuracy of 95% to effectively differentiate melanoma from benign lesions. The second clinical utility study was designed to evaluate changes in real world patient management based upon the myPath Melanoma test result. Results showed a 71% change in patient management from pre-test recommendations and an 81% reduction in biopsy site re-excisions for patients with a benign test result.
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