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  • unbearibull unbearibull Feb 8, 2009 1:59 PM Flag

    False positive - maybe not false?

    DNA testing will run in parallel with the RNA test going forward for both the LDT study and the FDA study for EVERY test subject. Two tubes of blood (10 ml) will be extracted from each patient - one will be RNA tested the other DNA tested - that is for everyone in all studies going forward.

    For the LDT commercialization - when a no call comes up in the RNA test, the DNA test will be reflexed. The DNA test WILL be commercialized as part of the LDT this year. The DNA test will also detect T-18 and T-13.

    When it comes time to submit to the FDA, only one methodology will be submitted - either RNA or DNA. The DNA testing will have zero effect on the timeline to LDT commercialization or FDA approval. The cost for additional DNA testing is minor and incremental. The DNA test is a simpler test and the COGS are less than the RNA test.

    My bet is on DNA test FDA approval in 2010.

    BTW - the American College of Gynocologists recommend many tests that are not FDA approved so endorsement by ACOG could accellerate devlopments as well.

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