Biotech Values

[DewDiligence]

EXAS—Question is if cumulative-sensitivity logic is appreciated by the FDA.

The answer is no, as noted at the bottom of my reply to iwfal in #msg-75642526.

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.

I fully agree.

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.

Unfortunately, the SAP of the DEEP-C pivotal study is based on a single sample (http://www.clinicaltrials.gov/ct2/show/NCT01397747 ).

That should improve accuracy but only in case the DNA markers are real good. So another question is how good are their markers?

That’s the $64,000 question. EXAS has done a lot of work in this regard and is still doing more (to potentially upgrade the assays) concurrently with running the DEEP-C study—see http://www.clinicaltrials.gov/ct2/show/NCT01260168.

All told, EXAS’ ColoGuard is a fairly high-risk program, IMO; however, there’s a very compelling medical need for something better, more tolerable, and less invasive than standard or virtual colonoscopy (even with the no-prep software enhancements). GIVN’s PillCam COLON 2 could play a role in this market, but it hardly seems like the ultimate solution.