Exact Sciences Corp. (EXAS), a provider of cancer screening and diagnostic tests, Friday said the U.S. Food and Drug Administration (FDA) has approved its Cologuard Plus test, a non-invasive multitarget stool DNA test for colorectal cancer screening.
The approval was based on results from the pivotal BLUE-C study, in which Cologuard Plus test showed sensitivities of 95 percent for colorectal cancer and 43 percent for advanced precancerous lesions at 94 percent specificity. Data from BLUE-C also showed that the Cologuard Plus test significantly outperformed an independent fecal immunochemical test for overall CRC sensitivity, treatable-stage CRC sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.
"Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent. This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening," said Kevin Conroy, Chairman and CEO of Exact Sciences.
The company plans to launch Cologuard Plus test in 2025.
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