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Myriad Launches $1,500 myPath Melanoma to Early-Access Pathologists

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Originally published Nov. 12.

Myriad Genetics this week launched its third new diagnostic in fiscal year 2014, called myPath Melanoma.

The company is marketing the 23-gene panel test as a tool that doctors can use to determine if a patient's skin lesion is malignant melanoma or benign. Carrying a list price of $1,500, Myriad is launching myPath Melanoma initially to early-access dermatopathologists in the US through a program called “The melEval Program.”

Myriad will use its own specialty sales force to market myPath Melanoma as a tool that pathologists can use to arrive at a more definitive diagnosis for suspicious, difficult-to-assess skin lesions. Myriad's website contains educational resources for patients through which the firm encourages once-a-month self-examinations and provides information to help identify unusual skin lesions. The company has also launched a website, called isthismelanoma.com, and has a Facebook page to spread the word about the test.

The American Cancer Society estimates there are 76,000 new patients diagnosed with melanomas and more than 9,000 deaths from the disease annually. Of the two million skin biopsies that pathologists perform each year, they classify 280,000 as “intermediate,” meaning that they cannot determine with a high degree of certainty whether the lesion is benign or malignant.

There is currently limited data available on MyPath Melanoma, as Myriad is still building the evidence-based around the test. The company recently announced results from a verification study involving more than 450 skin biopsy samples showing that the test had a sensitivity of 89 percent and a specificity of 93 percent. “Results of this study have recently been confirmed in an independent clinical validation study that will be presented at the American Academy of Dermatology in March 2014,” the company said in a statement announcing the staged launched of myPath Melanoma.

Myriad officials believe the global market opportunity for myPath Melanoma to be more than $800 million annually.

Before the market introduction of myPath Melanoma, Myriad also introduced the next-generation sequencing-based myRisk Hereditary Cancer test and the myPlan Lung Cancer test to early access customers.

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