Press release summary
Abbott said Oct. 20 that Cologuard Plus received CE marking under the European Union’s In Vitro Diagnostic Medical Devices Regulation, clearing a key regulatory step toward commercial introduction in selected European markets.
The noninvasive screening test analyzes multiple DNA markers and occult blood in a stool sample to detect colorectal cancer and advanced precancerous lesions. It is intended for average-risk adults age 45 and older. A positive result requires follow-up colonoscopy, and the test does not replace diagnostic or surveillance colonoscopy for people at high risk.
Abbott cited results from the prospective BLUE-C study of more than 20,000 participants. In the screened U.S. population, Cologuard Plus showed 95% sensitivity for colorectal cancer at 94% specificity, 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia. Abbott said the newer test also incorporates additional biomarkers and laboratory-process and sample-stability improvements compared with the original Cologuard.
For clinical laboratories, the CE mark matters because it may broaden European access to a high-volume molecular screening workflow while creating new demands for sample logistics, quality controls and follow-up coordination. Availability will vary by country based on reimbursement, health-system pathways and operational readiness.
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