On March 15, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported the results from the second pivotal clinical validation study for the myPath Melanoma test at the 2016 USCAP Annual Meeting in Seattle, Wash (Press release, Myriad Genetics, MAR 15, 2016, View Source [SID:1234509543]).

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"There is significant emotional distress associated with a melanoma diagnosis and doctors want to provide their patients with accurate information," said Loren Clarke, M.D., medical director, Myriad Genetic Laboratories. "We’re developing the myPath Melanoma test to help pathologists improve the diagnosis of melanoma, particularly for patients with difficult-to-diagnose skin lesions."

In the study with 736 patients, the myPath Melanoma test effectively diagnosed suspicious lesions with greater than 90 percent diagnostic accuracy, 91.5 percent sensitivity and 92.5 percent specificity. This second validation is consistent with the first validation study with 437 patients that demonstrated a diagnostic accuracy of greater than 90 percent.

"myPath Melanoma is an extremely robust diagnostic test with unmatched clinical validity data, having completed the largest clinical validation study for a melanoma diagnostic test," said Clarke. "We have now demonstrated in two pivotal validation studies that myPath Melanoma accurately differentiates patients with melanoma from those with benign moles."

The Company also announced that it will present new data on its myPlan Lung Cancer prognostic test at USCAP. Details about the featured Myriad presentations at USCAP are below. Follow Myriad on Twitter via @MyriadGenetics and stay up-to-date by using the hashtag #USCAP16.

myPath Melanoma Poster Presentation

Title: An independent validation of a gene expression signature to differentiate malignant melanoma from benign melanocytic nevi.
Date: Tuesday, March 15, 2016: 1:00 to 4:30 p.m. PT.
Location: Poster 84.
Presenter: Hillary Kimbrell, M.D., Myriad Genetic Laboratories.
In this clinical validation study, 736 melanocytic lesions, diagnosed as either benign or malignant by a panel of three expert dermatopathologists, were evaluated using the myPath Melanoma gene expression test. The results showed that the myPath Melanoma test differentiated malignant melanoma from benign nevi with a sensitivity of 91.5 percent and specificity of 92.5 percent. These findings were consistent across melanoma subtypes. There were several instances where the myPath test score differed from the pre-test diagnosis, causing the dermatopathologists to revise their initial diagnosis. These findings demonstrate the ability of the myPath Melanoma test to help diagnose cases of melanoma in samples representative of those seen in routine clinical practice.

myPlan Lung Cancer Poster Presentation

Title: Cell cycle progression score is a promising predictor of recurrence in primary lung carcinoid tumors.
Date: Monday, March 14: 1:00 to 4:30 p.m. PT.
Location: Poster 1874.
Presenter: Neda Kalhor, M.D., MD Anderson Cancer Center.
This exploratory study evaluated the cell cycle progression (CCP) score in pulmonary carcinoid tumors resected at the MD Anderson Cancer Center. The study cohort included 93 patients, including 79 with typical carcinoids (TC) and 14 with atypical carcinoids (AC). The results showed a significant association between the CCP score and recurrence free survival (RFS) in this cohort. These early findings suggest the CCP score may help in effective stratification of primary lung carcinoids to identify high-risk tumors that may require adjuvant therapy.

About myPath Melanoma
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. View Source

About Myriad myPlan Lung Cancer
Myriad myPlan Lung Cancer is a molecular prognostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in patients with early-stage non-small cell lung adenocarcinoma. For more information visit: View Source