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Sequenom Inc. Message Board

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  • unbearibull unbearibull Feb 11, 2009 7:00 PM Flag

    FDA Overhang

    Because Labcorp's Ovasure is not a direct test like SEQureDX. Ovasure uses a scoring method like APPY. It uses multiple variables. All the bruhaha is about using multiple variables to come up with a probability score. That's why APPY got shot down and why your comparisions of SQNM to APPY are laughable. SEQureDX is not an IVDMIA so it will not fall under FDA oversight. The real danger the FDA is concerned with is diagnostic companies using a black box algorithm to assign a score (IVDMIA's) for disease probablity - especially life threatening diseases such as cancer and in APPY's case - appendicitis.

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