Myriad Genetics presents research data that validates accuracy of myPath Melanoma test

Oct 31 2016

Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and personalized medicine, today announced it will present two new studies at the American Society of Dermatopathology (ASDP) annual meeting being held Oct. 27-30, 2016 in Chicago, Ill. The research being presented validates the accuracy of Myriad myPath^® Melanoma in differentiating benign skin nevi from malignant melanoma.

“We are presenting landmark data from the largest outcomes-based study ever performed with a melanoma diagnostic,” said Loren Clarke, M.D., medical director, Dermatology, Myriad Genetic Laboratories.  “The myPath Melanoma test performed very well and identified patients with melanoma versus benign skin lesions with greater than 95 percent diagnostic accuracy, which is exceptional in molecular diagnostics for cancer, particularly given the extreme heterogeneity of melanoma.”

“Pigmented or suspect skin lesions are difficult to diagnose in approximately 15 percent of cases,” said Sancy Leachman, M.D., Ph.D., chair of the Department of Dermatology in the Oregon Health & Science University School of Medicine and director of the Melanoma Research Program at the Knight Cancer Institute.  “A highly accurate biomarker like the myPath Melanoma test should help dermatologists augment their diagnosis of melanoma, improve patient care and lower healthcare costs.”

Below are the featured presentations at ASDP (#ASDP2016).

Poster Presentation

Title: Diagnostic Distinction of Malignant Melanoma and Benign Nevi by a Gene Expression Signature and Correlation to Clinical Outcome​.

Presenter: Jennifer Ko.

Date: Friday, Oct. 28, 2016: 4:15 – 5:00 p.m. and Saturday, Oct. 29, 2016 10:00 – 10:45 a.m. CT.

In this study, research collaborators from the Cleveland Clinic, Stanford University and Nottingham University assessed the clinical accuracy (sensitivity and specificity) of the myPath Melanoma test against clinical outcomes in 182 patients with skin lesions (99 melanomas and 83 nevi) with more than 5 years of follow up.  The results show that the myPath Melanoma test accurately differentiated benign lesions from melanoma with a sensitivity of 93.8 percent and a specificity of 96.2 percent when compared to known clinical outcomes.   The diagnostic accuracy of the myPath Melanoma test was high even in a subset of difficult-to-diagnose cases and, in combination with two previous validation studies, the findings support its use as an adjunct method for the early and accurate diagnosis of melanoma.

Podium Presentation

Title: Gene Expression Signature as an Ancillary Method in the Diagnosis of Desmoplastic Melanoma​.

Presenter: Loren Clarke.

Date: Sunday, Oct. 30, 2016: 8:20 – 8:30 a.m. CT.

The objective of this study was to assess the accuracy of the myPath Melanoma test in the differentiation of desmoplastic melanoma (DM) from benign skin lesions.  These lesions represent approximately one percent of melanomas, but are known to be very difficult to diagnose.  The analysis included samples from 20 patients with DM and 27 from patients with benign moles (nevi).  The results showed that the myPath Melanoma test was positive in 15 of the 20 known melanomas, negative in four and indeterminate in one.  The myPath score was negative in 24 of the benign nevi and indeterminate in three.  Based on these findings, the myPath Melanoma test demonstrated approximately 80 percent diagnostic accuracy in this very difficult-to-diagnose subtype.