- An FDA panel has unanimously determined that Cologuard, a noninvasive, stool-based DNA screening test for colorectal cancer, has demonstrated safety, effectiveness, and a favorable risk-benefit profile.
- Results of clinical trial show that Cologuard had a significantly higher sensitivity for detecting colorectal cancer compared with fecal immunochemical testing.
- Cologuard is used to analyze stool samples for the presence of DNA methylation and mutation markers, total DNA, and hemoglobin.
2.3% sensitivity for all 65 malignancies vs 74% for fecal immunochemical testing and 93.3% sensitivity in detecting the stage I–III colorectal cancers, vs 73% for fecal immunochemical testing.
In addition, sensitivity for patients with advanced precancerous lesions was 42% for Cologuard vs 24% for fecal immunochemical testing.
The DNA test detected 69% of patients with polyps with high-grade dysplasia vs 46% for fecal immunochemical testing.
Specificities for Cologuard vs fecal immunochemical testing were 87% vs 95%.