FDA Approves Next-Gen Noninvasive CRC Screening Test: Daily Dose

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On October 4, 2024, we reported on the US Food and Drug Administration (FDA) approval of Cologuard Plus, a multitarget next-generation stool DNA test, for adults at least 45 years of age who are at average risk for colorectal cancer (CRC).

The approval

The FDA's decision was based on findings from the pivotal multicenter prospective BLUE-C study in which, among a subset of 20 176 evaluable adults undergoing screening colonoscopy, Cologuard Plus showed an overall sensitivity for CRC of 93.9%, a specificity for advanced neoplasia of 90.6% as well as 43.4% sensitivity for advanced precancerous lesions at 92.7% specificity for nonneoplastic findings or negative colonoscopy.

Results also showed that in the first head-to-head comparison with fecal immunochemical testing (FIT) the Cologuard Plus was significantly more likely to detect CRC (94% vs 67%; P < .001) or advanced precancerous lesions (APL; 43% vs 23%; P < .001). The advanced test also showed higher sensitivity than FIT for high-grade neoplasia, the most clinically significant form of advanced precancerous lesions at 75% vs 47% ( P < .001).

Importantly, the performance of the next-gen DNA test was even better in younger age groups, at a specificity of 96% in individuals aged 45-54 years, a population at increasingly high risk for CRC.

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