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Myriad Adds to Melanoma Franchise with New Gene Expression Test Acquisition

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Myriad Genetics this week announced it has signed an agreement to acquire Melanoma Diagnostics' proprietary platform for the prognosis and diagnosis of skin cancer.

Under the terms of the deal, Myriad will have commercialization rights to "all tests derived from the technology on a worldwide basis in exchange for upfront fees and contingent payments based upon the commercial success of the products."

Myriad currently markets Melaris, a blood test to gauge the presence of p16 mutations, which can increase the hereditary risk of melanoma by 50 percent by age 50. According to Myriad, it will sell the new prognostic test acquired through Melanoma Diagnostics alongside Melaris through a new dermatology commercialization team it is building.

The new acquisition "will expand our presence in the solid tumor market," Mark Capone, president of Myriad Genetic Laboratories, said in a statement.

Melanoma Diagnostics is a spinout of the University of California, San Francisco, that has developed a biomarker panel that it claims allows pathologists to differentiate between benign moles and melanoma, as well as better assess the risk of cancer progression or metastasis.

The assay was described in a study published in the Proceedings of the National Academy of Sciences in April 2009. In the study, led by Mohammed Kashani-Sabet, a professor of dermatology at UCSF and a founder of Melanoma Diagnostics, UCSF researchers used a five-gene panel to pick which patients had melanoma from those with benign nevi with 95 percent sensitivity and 91 percent specificity. Based on the expression of five genes ─ ARPC2, FN1, RGS1, SPP1, and WNT2 ─ the researchers found that "both the intensity and pattern of expression of each marker were significantly different in melanomas compared to nevi."

In another study published in Clinical Cancer Research later in 2009, Kashani-Sabet and colleagues used a training set of 395 patients to develop a signature based on three genes — NCOA3, SPP1, and RGS1 — that could predict disease-specific survival and sentinel lymph node status in melanoma patients. In a validation cohort of 141 patients, the signature was determined to be "the most significant factor" predicting disease-specific survival, when compared to other clinical and histological factors.

Melanoma ranks as the seventh most common cancer in United States. However, diagnosing the cancer is "problematic," Myriad said, given that out of approximately 3 million skin biopsies annually, up to 450,000 of cases have an "ambiguous diagnosis."

Myriad did not respond to questions about this acquisition ahead of press time. It is currently unclear when the company plans to launch this test and whether additional validation work is necessary before the test is introduced to the market.

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