Myriad to Launch Two Melanoma Tests Based on Newly Acquired Technology

Originally published Dec. 13.

This story has been updated to include additional details from a Myriad spokesperson on the company's ongoing test development efforts in melanoma.

By Turna Ray

Myriad Genetics plans to launch a newly acquired diagnostic test for melanoma in the second half of 2011 and is planning to develop a prognostic test in melanoma linked to survival, a company spokesperson told PGx Reporter last week.

Myriad announced earlier this month that it had signed an agreement to acquire Melanoma Diagnostics' proprietary platform for the prognosis and diagnosis of skin cancer. Under the terms of the deal, Myriad has 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" (PGx Reporter 12/08/10).

Melanoma Diagnostics, a spinout from the University of California, San Francisco, has developed technology that allows pathologists to differentiate between benign moles and melanoma, and assess cancer progression and disease metastasis.

In a study published in the April 2009 issue of the Proceedings of the National Academy of Sciences, researchers affiliated with the company described a five-gene panel that was able to distinguish patients who 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."

Suzanne Barton, Myriad's director of investor relations, told PGx Reporter that the company has since obtained "excellent sensitivity and specificity" with the five-marker panel in clinical validation studies.

The diagnostic test will gauge these five genes involved in cell mobilization or cell growth and division, in order to "resolve diagnostic ambiguity between a melanoma and a benign nevus." This test will be launched in the second half of 2011.

Through its deal with Melanoma Diagnostics, Myriad has acquired technology and patent rights surrounding 12 genes in total. While the first diagnostic test will use the five genes mentioned above, the second test for disease prognosis will likely use a different set of genes, also acquired from Melanoma Diagnostics, according to Barton. However, the company has not yet settled on a development timeline for the second melanoma test assessing disease-specific survival.

However there is some published data on markers linked to survival in melanoma. In another study published in Clinical Cancer Research later in 2009, researchers affiliated with Melanoma Diagnostics 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.

According to Barton, in addition to the method-of-use patents on the 12 genes, Myriad has also acquired from Melanoma Diagnostics proprietary antibodies to each of the proteins produced by the 12 genes. "The [first] test that Myriad will develop will be an immunohistochemisty test based on the proprietary antibodies," she added.

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.

With Melaris already in its pipeline, and the addition of these two new melanoma tests, Myriad plans to carve out a new dermatology commercialization team to support its growing dermatology portfolio. In particular, the company is planning to add seven melanoma reps who will primarily reach out to dermatopathologists, Barton said.