Exact Sciences Corp. (EXAS), a leader in cancer screening and diagnostic tests, announced on Friday the approval of its Cologuard Plus test by the U.S. Food and Drug Administration (FDA). This innovative test is a non-invasive multitarget stool DNA test designed for colorectal cancer screening.
The FDA's approval is underpinned by data from the pivotal BLUE-C study, where the Cologuard Plus test demonstrated impressive results: a sensitivity of 95% for detecting colorectal cancer and 43% for advanced precancerous lesions, both measured at a specificity of 94%. Comparatively, this test significantly outperformed an independent fecal immunochemical test in overall CRC sensitivity, treatable-stage CRC sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.
"Cologuard Plus provides improved detection of cancers and precancerous polyps, boasting greater sensitivity than the original Cologuard while reducing false positives by over 30%. This breakthrough is especially vital now, as 60 million Americans are not current with their cancer screenings," remarked Kevin Conroy, Chairman and CEO of Exact Sciences.
The company intends to introduce the Cologuard Plus test to the market in 2025.
