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Sequenom Inc. Message Board

  • unbearibull unbearibull Feb 10, 2009 7:51 PM Flag

    Ken Luskin's (onlypro) lies - revisited

    OK boys and girls, time for a review...

    1. RNA test is a failure.
    LIE - 1 false positive, no false negatives out of 858 samples - specificity of 99.7% and 100% sensitivity.

    2. No calls were actually wrong calls.
    LIE - study was blind, independantly verified

    3. SQNM is a scam.
    LIE

    4. SQNM's data is cooked.
    LIE - study was blind etc.

    5. Tests will not work in the real world
    LIE - current tests just reported were done with real world procedures.

    6. SQNM requires OBGYNs to freeze blood.
    LIE - OBGYNs transport blood by courier to a lab processing site where the samples are spun, separated and frozen then shipped to a lab for analysis.

    Listen here..... http://www.zshare.net/audio/55305264fc67...

    7. In the real world all samples are included.
    LIE - failures are rarely reported in pilot trials

    8. SQNM's RNA test needs FDA approval.
    LIE - almost 40% of CLIA labs do not use FDA approved tests at all, and another 26% use them for less than 25% of the tests they offer. Per FDA guidelines SQNM's RNA test is not an IVDMIA and is excluded from FDA oversight.

    link (page 6, bullet 3)...
    http://www.fda.gov/cdrh/oivd/guidance/1610.pdf

    9. SEQureDX will never be accepted by the medical community due to "no-calls".
    LIE - Physicians will evaluate the utility of SEQureDX compared to the current regimen for prenatal Downs screening which is a series of tests over several weeks. The number of no-calls (5%-7% in the real world) will have negligible bearing on their decision when the obvious advantages of accuracy, timeliness and cost are so clear.

    In the event of a no-call, when a patient's only loss is a tube of blood and the loss of time it takes to draw the blood, versus the 95% chance that there will be a definitive answer to the health of their baby, Physicians and mothers will take that chance.

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