Exact Science second-generation Cologuard shows high sensitivity, improved specificity
Exact Science announced its second-generation Cologuard test performance data, according to a company press release.
The test showed an “overall sensitivity of 95.2% for colorectal cancer at specificity of 9% for negative samples confirmed by colonoscopy.” Subgroup analyses showed 83.3% sensitivity for high-grade dysplasia and 5% for all advanced precancerous lesions.
"The Exact Sciences team is constantly innovating to help make earlier cancer detection a routine part of medical care," Kevin Conroy, chairman and CEO, said in the release.
The study design simulated a true screening population 777 stool samples collected in the U and Canada across 134 sites better predict real-world performance of the marker panel.
"Exact Sciences and Mayo Clinic scientists worked together to discover these new methylation markers, which demonstrate improved performance over first-generation Cologuard markers," Paul Limburg, MD, MPH, AGAF, chief medical officer for screening at Exact Sciences, said in the release. "In particular, the observed increased specificity suggests that false positive screening results can be reduced, which has important implications for clinical practice and decision-making."