Biotech Values

[DewDiligence]

Cologuard is intended for people with an “average” risk for colorectal cancer, which excludes someone with a history of adenoma polyps.

If you took the Cologuard test anyhow (despite a history of polyps), it would not necessarily come back with a false positive, but the tradeoff between false positives and false negatives inherent in any diagnostic would be skewed so that the test result would have less predictive value than for someone with average risk.

This is the original (2014) Cologuard FDA label:
https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130017C.pdf . (In 2019, the lower bound for the age range was reduced from 50 to 45.)