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.
The regulatory clearance enables the company to introduce the noninvasive test across select European markets, with deployment timelines subject to national healthcare pathways, operational readiness, and reimbursement.
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Designed for adults aged 45 and above at average risk, the test analyses at-home stool samples for neoplasia-linked deoxyribonucleic acid (DNA) markers and occult blood without requiring bowel preparation, sedation, dietary changes, or time away from daily activities.
Abbott stated that positive findings warrant follow-up colonoscopies while clarifying that Cologuard Plus does not replace diagnostic or surveillance colonoscopies in high-risk patients.
Clinical data from the prospective, multi-centre BLUE-C trial of more than 20,000 participants showed 95% sensitivity at 94% specificity for colorectal cancer detection in the US cohort.
The test identified 43% of advanced precancerous lesions and 74% of high-grade dysplasia cases.
Enhanced laboratory methods, sample stability, and novel biomarkers also reduced false-positive findings by up to 40% compared with the original version.
Abbott cancer diagnostics business senior vice-president Jake Orville said: “Screening is one of the most powerful tools we have in the fight against colorectal cancer, but it only works when people complete it.
“Cologuard has helped transform colorectal cancer screening in the US by giving people an effective, convenient option they can complete at home. With Cologuard Plus, we’ve built on that experience with even stronger performance.
“Receiving CE Mark is an important step toward bringing this option to more people and helping address unmet screening needs across Europe.”
Developed alongside Mayo Clinic, both Cologuard and Cologuard Plus utilise stool-based technology, with the initial test recording more than 23 million screenings in the US since its 2014 launch.
Earlier this month, Abbott received approval from the US Food and Drug Administration (FDA) for its CardioMEMS HF system capabilities, introducing new digital features that allow individuals to track their cardiac data directly on mobile devices.
