Performance data for a second-generation Cologuard (multi-target stool DNA) test showed an overall sensitivity of 95.2% for colorectal cancer at specificity of 92.4% for negative samples confirmed by colonoscopy.
Cologuard is sponsored by Exact Sciences Corp.
Subgroup analyses showed 83.3% sensitivity for high-grade dysplasia and 57.2% for all advanced precancerous lesions. The data will be presented Jan. 22, 2022 at ASCO GI in a poster titled, “Second-generation Multi-target Stool DNA Panel Reliably Detects Colorectal Cancer and Advanced Precancerous Lesions.”
Cologuard is the first and only FDA-approved, non-invasive stool DNA test used to screen average-risk people for CRC. Exact Sciences is developing a second-generation Cologuard to improve the specificity and precancer sensitivity of the test, decreasing the false positive rate and increasing the detection rate of precancerous lesions. The study showed the potential of a panel of methylated DNA markers and fecal hemoglobin to accomplish both in a real-world setting.
The study was designed to simulate a true screening population and better predict real-world, prospective performance of the marker panel. It included non-advanced precancers, samples collected prospectively across all precancer types and sizes, and colorectal cancer samples weighted heavily towards early stages.
The study consisted of 777 stool samples collected in the United States and Canada across 134 sites, including 112 cancers—78% in stages I and II, 98 prospectively collected advanced precancerous lesions, 176 non-advanced precancerous lesions, and 391 negative controls.
A multi-center pivotal trial evaluating second-generation Cologuard markers is ongoing, and results are expected late 2022 or early 2023. Exact Sciences plans to use results of the ongoing trial to support an FDA submission and approval and make the enhanced Cologuard test available broadly.
