Abbott Obtains CE Mark for Cologuard Plus Cancer Test

Abbott has secured CE Mark approval under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) for its Cologuard Plus colorectal cancer screening test, enabling European market introduction of the non-invasive stool-based diagnostic. Announced on 21 October 2026, the clearance opens substantial new commercial territory across European CRC screening programmes, sharpening competitive positioning against blood-based CRC diagnostics and traditional colonoscopy workflows across the growing non-invasive cancer screening category.

Designed for adults aged 45+ at average risk, Cologuard Plus analyses at-home stool samples for neoplasia-linked DNA markers and occult blood without requiring bowel preparation, sedation or dietary changes. Clinical data from the prospective, multi-centre BLUE-C trial of more than 20,000 participants demonstrated 95% sensitivity at 94% specificity for colorectal cancer detection in the US cohort, with 43% of advanced precancerous lesions and 74% of high-grade dysplasia cases identified. Enhanced laboratory methods and novel biomarkers also reduced false-positive findings by up to 40% compared with the original Cologuard. Positive findings warrant follow-up colonoscopies.

Developed alongside Mayo Clinic, both Cologuard and Cologuard Plus use stool-based technology, with the original test recording more than 23 million US screenings since its 2014 launch. Jake Orville, Senior Vice-President of Abbott’s cancer diagnostics business, positioned the launch as building on Cologuard’s US success. The CE Mark intensifies competitive pressure across the non-invasive CRC screening market, challenging blood-based competitors Guardant Health (Shield), Epigenomics (Epi proColon) and Freenome, stool-based specialists Mainz Biomed (ColoAlert) and traditional fecal immunochemical test (FIT) suppliers.

The commercial signal is a maturing non-invasive colorectal cancer screening category where European IVDR access unlocks substantial addressable patient populations and sharpens competitive dynamics between stool-based diagnostics, blood-based cancer screening and colonoscopy triage. CE Mark is a key gating milestone. Expect Guardant Health, Epigenomics, Freenome, Mainz Biomed, Olympus, Boston Scientific and Fujifilm Medical to sharpen European CRC positioning through 2027.

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