On April 5, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it 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 (Press release, Myriad Genetics, APR 5, 2017, View Source [SID1234518491]). The Company also announced it 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.

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"The pivotal results from these two studies join a number of additional publications, which is the culmination of five years of extensive scientific research and innovation," said Vicki Fish, vice president, Dermatology Business Unit, Myriad Genetic Laboratories. "We believe that our reimbursement dossier is exceptionally strong, and we will work with health plans to ensure this test is widely accessible to the physicians and patients who need it."

The third clinical validation titled "Diagnostic Distinction of Malignant Melanoma and Benign Nevi by a Gene Expression Signature and Correlation to Clinical Outcomes" 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 (99 primary melanomas with distant metastases and 83 benign moles). The median time to melanoma metastasis was 18 months and the median follow-up time for benign moles was 75 months. The results showed that the myPath Melanoma test had an overall diagnostic accuracy of 95 percent to effectively differentiate melanoma from benign lesions. These strong findings demonstrate that the myPath Melanoma test closely correlates with long-term clinical outcomes and adds valuable information to assist in the accurate diagnosis of melanoma.

The second clinical utility study titled "The Influence of a Gene Expression Signature on the Treatment of Diagnostically Challenging Melanocytic Lesions" was published in the journal Personalized Medicine. This study was designed to evaluate changes in real world patient management based upon the myPath Melanoma test result. Samples from 77 patients with suspicious skin lesions (i.e., melanocytic neoplasms) were tested using the myPath Melanoma test accompanied by pre-test documentation of the intended treatment recommendations. The actual treatment provided by dermatologists was then documented after testing. The results showed there was a 71 percent change in patient management from pre-test recommendations and an 81 percent reduction in biopsy site re-excisions for patients with a benign test result. Based on these findings, the myPath Melanoma test significantly influenced the physicians’ treatment of patients.

A list of the key analytic validation, clinical validation and clinical utilities studies that comprise the myPath Melanoma reimbursement dossier follows below.

Key Elements of myPath Melanoma Reimbursement Dossier

Study Key Result Peer-Reviewed Publication
Clinical Validation 1 (n=437) • >90 percent diagnostic accuracy Journal of Cutaneous Pathology (2015)
Clinical Validation 2 (n=736) • >91 percent diagnostic accuracy Cancer (2016)
Clinical Validation 3 (n=182) • >95 percent diagnostic accuracy Cancer Epidemiology, Biomarkers & Prevention (2017)
Analytic Validation (n=544) • Only 2.5 percent standard deviation of the score High dynamic range, precision, RNA yield Biomarkers in Medicine (2015)
Clinical Utility 1 ( n=218) • >50 percent increase in definitive diagnoses for cases that were originally diagnosed as indeterminate.
• ~50 percent change in treatment recommendations for diagnostically challenging cases. Medicine (2016)
Clinical Utility 2 (n=77) • 71 percent change in patient management from pre-test recommendations
• 81 percent reduction in excisions for patients with a benign test. Personalized Medicine (2017)
Health Economic • 8.3 percent reduction in 10-year costs per patient.
• Savings of $.067 per member per month. Journal of Medical Economics (2014).

"Melanoma is one of the fastest growing cancers in the United States, and there is demand among physicians for an objective, high quality, clinically validated molecular diagnostic test to be used as an adjunct to conventional tools like the microscope," said Loren Clarke, M.D., board-certified dermatopathologist and medical director, Dermatology, Myriad Genetic Laboratories. "We believe myPath Melanoma is one of the most studied and accurate molecular diagnostic tests ever developed. It has enormous potential to help save the lives of people with melanoma, spare people with benign moles from unneeded treatment and lower costs for our healthcare system."

Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates about myPath Melanoma from the Company.

About Melanoma
Melanoma is one of the fastest growing cancers in the United States and can strike people of all ages, races and skin types. With a one-in-50 lifetime risk of developing melanoma, nearly 87,000 Americans are expected to be diagnosed with Stage I-IV melanoma and another 75,000 will be diagnosed with melanoma in situ — totaling approximately 162,000 total diagnoses. Early and accurate diagnosis of melanoma is critical for long-term survival. For more information visit: www.mypathmelanoma.com/.

About Myriad myPath Melanoma
Myriad myPath Melanoma is a clinically validated test to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. The test measures the expression of 23 genes and accurately distinguishes melanoma from benign nevi.