Cologuard Plus Gains FDA Nod, Offers Enhanced Colorectal Cancer Detection

The US Food and Drug Administration (FDA) has approved Exact Sciences’ Cologuard Plus, a next-generation, non-invasive colorectal cancer (CRC) screening test for adults aged 45 and older at average risk for CRC.

Cologuard Plus builds on the original Cologuard test by incorporating enhanced biomarkers and laboratory processes, offering a more effective way to detect CRC at earlier, treatable stages and identify advanced precancers.

The approval is based on findings from the BLUE-C study, a large-scale trial involving nearly 19,000 participants. Cologuard Plus demonstrated a 95 percent sensitivity for overall cancer detection and a 43 percent sensitivity for advanced precancerous lesions, with a 94 percent specificity in individuals with no findings — or no evidence of colorectal cancer or precancerous lesions — on colonoscopy. The study results showed that Cologuard Plus outperformed a fecal immunochemical test (FIT) in detecting treatable-stage CRC, high-grade dysplasia and advanced precancerous lesions.

This new test also aims to reduce false positives, minimizing unnecessary follow-up colonoscopies. The test maintained a 93 percent specificity rate in individuals with no findings, weighted to reflect the age range of the US population. These sensitivity and specificity metrics reflect the test’s accuracy in detecting CRC and advanced precancerous lesions.

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The original Cologuard test allowed patients to test at home without special preparation, identifying DNA markers and blood in stool linked to CRC and precancer. Modeling data over the past decade indicated that it had detected more than 623,000 cancers and precancers, likely saving the US healthcare system an estimated $22 billion.

Cologuard Plus further advances these capabilities with novel biomarkers and improved Cologuard Plus sample stability, giving patients more time to return their samples and enhancing the rate of valid results.

Exact Sciences is also actively addressing CRC disparities through its FOCUS Program, which awarded $1.5 million in 2024 to 28 organizations, aiming to increase screening access, particularly for underserved populations.

Exact Sciences plans to launch Cologuard Plus in 2025, focusing initially on Medicare coverage and inclusion in the US Preventive Services Task Force guidelines. Supported by the company’s ExactNexus technology platform, this non-invasive screening option will be accessible to over 350 health systems, addressing the pressing need for CRC screening.