The blood test also showed 31.2% sensitivity for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy, according to a Sept. 16 press release.
The study consisted of more than 3,000 blood samples, including approximately 2,900 blinded, using an analysis that was prespecified by the FDA.
The study also included more than 90 advanced precancerous lesions, the majority of which were prospectively collected, and 60 case-collected colorectal cancer samples.
“A blood-based colorectal cancer screening test that can detect advanced precancerous lesions at a level comparable to the FIT test would be a breakthrough in this field,” Paul Limburg, MD, chief medical officer for screening at Exact Sciences, said in the release. “Results from this large, well-designed study show progress toward that goal and move us one step closer toward providing average-risk patients with another non-invasive screening option.”
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