Episode 272: 271. Cologaurd Has a New Test? How Good is it?

The company that developed Cologuard also developed this “next generation” multitarget stool DNA test, and has applied for U.S. FDA approval. The new test appears to have similar sensitivity and higher specificity than its predecessor — which means fewer false positives.  Positive predictive value (the proportion of positive tests that were true positives for cancer or advanced neoplasia) was 11%. Negative predictive value (the proportion of negative tests that were true negatives for cancer or advanced neoplasia) was 93%. The stool DNA test was substantially more sensitive than FIT (94% vs. 67% for cancer; 43% vs. 23% for advanced precancerous lesions), but slightly less specific. https://www.nejm.org/doi/10.1056/NEJMoa2310336