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Re: The Rainmaker post# 3611

Wednesday, 03/30/2011 4:17:13 PM

Wednesday, March 30, 2011 4:17:13 PM

Post# of 5735
That's true. What the FDA will want to see, though, is a test that can identify a range from no cancer to those with lung cancer. BMOD is going to have to be able to prove that cypath does this accurately.

It's important that they pick up on some cancers that current non-invasive methods are missing (sensitivity). But for this to become a standard screen paid for by insurance companies, it is equally important that the test does not have false positives (specificity).

I'm wondering if 58% specificity needs to be improved upon before the FDA will approve cypath. The FDA and the insurance companies won't want to approve a test that sends 42 cancer-free people out of every 100 positive tests to get a catscan unnecessarily.

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