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Continuing Push to Diversify Offerings, Myriad Licenses Chronix's Early Cancer Detection Technology

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Originally published May 10.

By Turna Ray

Continuing efforts to diversify its product pipeline, Myriad Genetics announced this week that it has acquired an exclusive license to commercialize Chronix Biomedical's technology for the early detection of cancer.

Chronix has yet to complete validation studies for its prostate, breast, and colon cancer tests, however, so questions remain as to when the license will begin adding to Myriad's revenues.

The deal follows Myriad's announcement in late April that it would acquire Rules-Based Medicine for $80 million. The acquisition, slated to close by the end of the month, will give Myriad a greater footprint in the companion diagnostics space as well as access to outcomes-linked patient samples to conduct test validation studies (PGx Reporter 05/04/2011).

Myriad's recent ramp-up in M&A activity, expansions, and collaborations is a sign that the company is looking to improve its image on Wall Street. Some investors and analysts have observed that while sales of the company's flagship BRACAnalysis test, accounting for close to 90 percent of its revenues, are leveling off, revenues from its other products aren't mature enough to contribute significantly to earnings in the near term.

Regarding its deal with Chronix, a Myriad spokesperson told PGx Reporter that "this technology is in its early stages of development and therefore we have not put forth revenue or product launch dates."

Chronix's tests rely on disease-specific biomarkers based on DNA fragments that are released into the bloodstream by damaged and apoptotic cells

Under the terms of the licensing agreement, Myriad will have exclusive commercialization rights in North America, South America, and Europe for tests based on the technology for the early detection of breast, colon, and prostate cancer. Myriad will also help validate these tests and will pay Chronix an undisclosed sum in upfront fees, milestone payments, and royalties upon the "technical and commercial success of the products."

If the development and commercialization of these early detection cancer tests are successful, it could end up being a profitable investment for Myriad in the long term. The American Cancer Society estimates that there were a half million newly diagnosed cases of breast, colon, or prostate cancer last year, and more than 70 million screening tests are performed each year in these cancer settings. According to the National Cancer Institute, when patients' breast, colon, and prostate cancers are caught in the early stages of their disease, they have a 90 percent chance of five-year survival. When these cancers are detected at more advanced stages, patients' five-year survival drops to 30 percent.

A trifecta of early detection oncology tests certainly fits nicely into Myriad's existing product portfolio. In addition to BRACAnalysis, Myriad currently markets Colaris and Colaris AP, genetic tests that gauge patients' risk of hereditary colorectal cancer, and Prolaris, a test that measures the expression level of genes to assess the aggressiveness of patients' prostate cancer.

"This acquisition is consistent with our strategy to broaden our preventive care portfolio beyond predictive medicine products for women's health, and supply healthcare providers with enhanced tools to catch disease early, when it is most treatable," Myriad Genetics Laboratories President Mark Capone said in a statement.

Chronix's technology, upon which its early detection cancer tests are based, applies proprietary algorithms to detect and analyze DNA fragments released into the blood by dying cells. These DNA fragments originate from chromosomal hotspots on the human genome that are linked to certain illnesses. Chronix's diagnostic tests, by honing in on these areas, can detect the presence of disease without having to isolate and analyze tumor cells.

It appears that Myriad will have flexibility as to the specific platform it uses to commercialize Chronix's tests. Chronix CEO Howard Urnovitz described the company's technology as platform agnostic, "in that multiple platforms can be used to detect the cancer-specific DNA fragments that originate from chromosomal hotspots." Detecting cancer-specific serum DNA, and not being dependent on analyzing the cancer cell, "allows for a more efficient and cost-effective protocol necessary for widespread screening," he said.

At the American Society of Clinical Oncology's annual meeting last year, Chronix presented data from a study involving 575 patients showing that its assay detected breast cancer and invasive prostate cancer with 92 percent sensitivity and 100 percent specificity (PGx Reporter 06/16/2010).

"Myriad will expand on this initial research with the goal of developing molecular diagnostic products which are less invasive and significantly outperform the accuracy of current early detection methods," the company said in a statement announcing the licensing deal.

Urnovitz said the company would provide more information about the timing and design of the validation studies it will conduct with Myriad as these programs advance.


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