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Genomic Health Inc. Message Board

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  • brotherlu2003 brotherlu2003 Sep 18, 2012 10:51 PM Flag

    Prostate Cancer Test nearing Commercialization

    Hello board,

    Pretty familiar w/ biotechs that produce drugs and the pre-clinical to phase three to approval process.

    I also know that medical devices, such as ISRG's went through a different FDA process than drugs. Can any of you clarify for me the main steps to what I assume is a FDA approval for tests? Prostate cancer market seems huge, love the Baker Brothers, but couldn't really understand clinical trials, phases, approval from their website.

    Thanks in advance.

    Sentiment: Buy

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    • The procedures the FDA looks for with diagnostics is much different than the Phase 1 2 3 NDA etc for a drug.For the sake of this board - ; - ) look on the FDA site. "trials are replaced with data that is "peer reviewed" (Academia) .The process helps the FDA sort ot the Commercialism of some bios.What makes Genomic Health the class act ,is that they almost furnish "drug trial" dat to insure the decision quickly ,,,as they did on prostate Best ! Terry

 
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