Myriad Genetics is acquiring Melanoma Diagnostics’ technology, which reportedly uses validated genetic markers, for the diagnosis and prognosis of malignant melanoma. Myriad thus obtains the right to commercialize all tests derived from the technology on a worldwide basis in exchange for up-front fees and contingent payments based upon the commercial success of the products.
The clinical validation of the melanoma genetic markers used in this technology were published in Proceedings of the National Academy of Sciences by Kashani-Sabet, M.D., founder of Melanoma Diagnostics. A training and validation set (n=693) measured the expression levels of five genes by immunohistochemistry to differentiate patients with melanomas from those with benign nevi. Sensitivity was reportedly 95%, and specificity 91%.
In a second publication in Clinical Cancer Research, Dr. Kashani-Sabet demonstrated in a separate training and validation set (n=536) that these genetic markers were the most significant factor in predicting disease-specific survival when compared to other clinical factors.
“The tests that may be developed from the technology that we are acquiring may provide physicians with important information in the differential diagnosis of melanoma from otherwise benign moles and in understanding the aggressiveness of the patient’s disease,” comments Mark Capone, president of Myriad Genetic Laboratories.
There are approximately 3 million skin biopsies done every year, and physicians estimate that up to 450,000 of those cases have an ambiguous diagnosis, according to Myriad. Failure to accurately diagnose melanoma is one of the leading causes for medical litigation in the U.S., the firm adds.
Remarking on the deal, Capone says, “This will expand our presence in the solid tumor market as we develop a dermatology commercialization team that also will market our existing Melaris® test for melanoma predisposition.”
Melaris is a blood test that detects the p16 gene mutation. Myriad says that such a mutation increases a person’s risk of melanoma by up to 50 times by age 50.
Myriad markets a slew of cancer diagnostic and prognostic tests including BRACAnalysis (breast cancer risk test), Colaris and Colaris AP (colorectal and uterine cancer risk tests), PreZeon (measures PTEN gene), prolaris (prostate cancer prognostic test), OnDose (measures exposure to 5-FU chemo), and TheraGuide 5-FU (predicts toxicity to 5-FU chemo).
The firm has come under legal fire because of its BRACAnalysis test. In May 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a lawsuit against the company, the University of Utah Research Foundation, and the USPTO.
It challenged the USPTO’s authority to issue patents that relate to products of nature as well as the legitimacy of claims issued to Myriad Genetics that relate to isolated DNA encoding the breast cancer markers BRCA1 and BRCA2 and to methods of detecting alterations in BRCA1 gene sequence to diagnose cancer.
In March the District Court in the Southern District of New York ruled that the patents on BRCA1 and 2 are invalid. Myriad is appealing that ruling in the U.S. Court of Appeals for the Federal Circuit. In November the U.S. Justice Department filed a friend-of-the-court brief, supporting the ACLU and PUBPAT.