10,000 patients study before FDA approval???Just for information purpose...First take a look in this link from FDA approval process.
https://www.fda.gov/news-events/approvals-fda-regulated-products/about-fda-products-approval '' FDA has streamlined its review process.....the average review time for an innovative new drug is now 6 months''.
It doesn' say anything about blood tests although it should be quite the same.
In the next link check the paragraph...
Cologuard:Reducing the Human Cost of the Colorectal Cancer Screening Gap. In this paragraph its seem to indicate that a 10,000 study was necessary before Cologuard FDA approval.
https://www.exactsciences.com/hubfs/Whitepaper-%20Final%20draft%20copy.pdf In this next link check the paragraph
'' abstract'' you will see that SZLS (Genenews) did a study on 10,000 patients.
https://www.genenews.com/uploads/1/4/5/4/14548558/stabilityofthecolonsentry_ijdm-101_2019jan.pdf We don't know what are the other steps necessary for an FDA approval, but at least SZLS seem to have the 10,000 patients study necessary for the FDA approval process.