Abbott Secures CE Mark for Cologuard Plus Colorectal Cancer Screening Test in Europe

Abbott has announced that it secured CE Mark approval under the European Union In Vitro Diagnostic Medical Devices Regulation for its Cologuard Plus colorectal cancer screening test. The regulatory clearance permits the company to introduce the noninvasive test across select European markets, though deployment timelines remain subject to national healthcare pathways, operational readiness, and local reimbursement frameworks.

Overview of the Noninvasive Screening Option

Designed for adults aged 45 and older who are at average risk for colorectal cancer, the test examines at-home stool samples for neoplasia-linked DNA markers and occult blood. The procedure does not require bowel preparation, dietary changes, sedation, or time away from daily activities. Abbott noted that positive screening results indicate the need for a follow-up colonoscopy, but clarified that the tool does not replace diagnostic or surveillance colonoscopies for high-risk patients.

Clinical Trial Performance and Findings

The regulatory approval is supported by clinical data from the prospective, multi-centre BLUE-C trial, which enrolled more than 20,000 participants. Findings from the US cohort demonstrated 95% sensitivity and 94% specificity for colorectal cancer detection. Furthermore, the test successfully identified 43% of advanced precancerous lesions and 74% of high-grade dysplasia cases.

According to company data, the updated testing format incorporates enhanced laboratory methods, improved sample stability, and novel biomarkers. These technological refinements reduced false-positive findings by up to 40% compared to the original version of the test.

Expert Perspectives and Development Background

Jake Orville, senior vice-president of Abbott’s cancer diagnostics business, emphasised the importance of accessible screening methods. Screening serves as a vital tool against colorectal cancer, he stated, but noted its success depends on patient completion rates. The original version helped transform screening in the US by offering a convenient at-home alternative, and the newer iteration builds on that foundation with stronger performance metrics to address unmet screening needs across Europe.

Developed in collaboration with the Mayo Clinic, the technology builds upon stool-based screening methods that have recorded more than 23 million completions in the US since their initial launch in 2014.

• Approved under EU In Vitro Diagnostic Medical Devices Regulation
• Intended for average-risk adults aged 45 and older
• Analyzes at-home stool samples without requiring bowel preparation
• Demonstrated 95% sensitivity and 94% specificity in the BLUE-C trial