Exact Sciences Corp. (NASDAQ: EXAS) today announced performance data for a second-generation Cologuard (multi-target stool DNA) test showing overall sensitivity of 95.2% for colorectal cancer (CRC) at specificity of 92.4% for negative samples confirmed by colonoscopy. Subgroup analyses showed 83.3% sensitivity for high-grade dysplasia, the most dangerous precancerous lesions, and 57.2% for all advanced precancerous lesions. These data will be presented January 22 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 shows the potential of a highly discriminate panel of methylated DNA markers and fecal hemoglobin to accomplish both in a real-world setting. If approved, the second-generation Cologuard test could help increase screening rates while sending fewer people to follow-up colonoscopies unnecessarily and identifying more advanced precancers before they progress to cancer, helping prevent the disease.
“The Exact Sciences team is constantly innovating to help make earlier cancer detection a routine part of medical care,” said Kevin Conroy, chairman and CEO. “These data demonstrate our commitment to patients and the power of our research and development teams, scientific platform, and expertise in colorectal cancer screening.”