Biotech Values

[genisi]

no-prep test such as EXAS’ ColoGuard can be repeated often, allowing the cumulative sensitivity of a series of tests to be impressively high for both cancer and pre-cancer even when the sensitivity of each individual test is only middling.

Question is if cumulative-sensitivity logic is appreciated by the FDA. The FDA wants a comparison to the gold standard-colonoscopy and if ColoGuard sensitivity and specificity in an individual test is only middling it won't pass like GIVN's 1st generation pill. A possible solution (maybe that's what EXAS is doing, please share if you know), is to perform each test on a few different samples for every individual with several repeats. That should improve accuracy but only in case the DNA markers are real good. So another question is how good are their markers.