Abbott said Oct. 20 that its Cologuard Plus test received a CE mark under the European Union’s In Vitro Diagnostic Medical Devices Regulation, advancing its plans for colorectal cancer screening in Europe.
A stool sample collected at home is checked for blood and DNA indicators linked to colorectal cancer and advanced precancerous lesions. Abbott says the test is intended for adults 45 and older at average risk. A positive result should be followed by a colonoscopy. The company says sample collection requires no bowel preparation, dietary changes or sedation.
FDA-approved labeling reports results for 18,911 participants in the primary effectiveness population of the U.S. BLUE-C study. Cologuard Plus detected 81 of 85 colorectal cancers, giving it 95.3% sensitivity. It also detected 849 of 1,962 advanced precancerous lesions, or 43.3% sensitivity.
The labeling reports 90.7% specificity among participants who had neither colorectal cancer nor advanced precancerous lesions. Abbott’s rounded 94% figure uses a narrower group with no colorectal neoplasia and is weighted by age to the U.S. population. The labeling gives that measure as 93.8%. The two specificity figures describe different groups and should not be treated as interchangeable.
A joint report by the Organisation for Economic Co-operation and Development and European Commission puts the unweighted average for reporting EU countries at 42%. That measure covers colorectal cancer screening in the preceding two years among people ages 50 to 74, using data from 2022 or the nearest available year. The report describes national or regional programs that generally offer stool testing every two years for that age group.
Abbott completed its acquisition of Cologuard developer Exact Sciences on March 23. Jake Orville, senior vice president of Abbott’s cancer diagnostics business, said screening “only works when people complete it.”
Abbott plans to introduce Cologuard Plus in selected European markets but has not named them or set launch dates. The company says availability will depend on local care pathways, reimbursement and operational readiness.
