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GetSeriousOK

08/23/15 7:14 PM

#29754 RE: livinginsv #29753

A better name would be "Can't Be Sure."

The poor sensitivity/specificity makes it useless as a screener. Even MacLellan adnitted that in one of the conference calls.

That's why the FDA rejected the 510(k) twice and finally cleared the test as a CRC monitoring device ONLY.

Every entity trying to market DR-70 as a screener is trying to pull the wool over someone's eyes.