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Personalized Medicine Makes Significant Headway Following the Rapid Evolution of U.S. Molecular Diagnostics Market, Finds Frost & Sullivan
Date:5/5/2009

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"The development of companion diagnostics is a game-changing phenomenon, which will impact the structure and dynamics of the pharmaceutical and biotechnology industry in the near future," advises Frost & Sullivan Senior Analyst Dr. Sudeep Basu. "Companion diagnostics will drive M&A activity and strategic partnerships in this market, in addition to encouraging a systems biology approach in attacking pathways as opposed to single targets."

The National Institute of Health-National Cancer Institute (NIH-NCI) programs, the FDA's Critical Path Initiative, and the availability of advanced tools have also speeded up market momentum. The Oncology Biomarkers Qualification Initiative (OBQI) program marshals public and private support to collaborate and develop the new rules of the game.

Considering the obvious benefits offered by this method and the lack of any deleterious effect observed with the testing, the likelihood of FDA granting approval for this method is high.

The flux in the regulatory environment surrounding the U.S. CMD market poses a major challenge to companies operating in this domain. Frequent adjustments to changing time lines and interim guidelines have proved to be an impediment for new entrants attempting to introduce novel tests to market.

"While FDA approval is no guarantee of market success, it surely helps the process," adds Dr. Basu. "FDA approval is based on a host of factors, and importantly, is an approval of the high levels of clinical relevance of the test, and low levels of risk which stems from the significant clinical studies carried out by the company for validating the diagnostic assay."

Besides adjusting to the ever-changing regulatory environment, participants must skillfully navigate the reimbursement space to ensure that growth continues on an upward trajectory.'/>"/>

SOURCE Frost & Sullivan
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