Abbott Park, Illinois, USA, October 20, 2026
Abbott has announced that its Cologuard Plus® colorectal cancer screening test has received CE Mark certification under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR). The regulatory milestone paves the way for the company to introduce the noninvasive, stool-based DNA screening test in selected European markets. Designed to detect colorectal cancer and advanced precancerous lesions, Cologuard Plus offers an at-home testing approach that may help expand screening options and address gaps in early detection. Abbott plans to introduce the test country by country, with availability depending on local healthcare pathways, reimbursement arrangements and operational readiness.
Cologuard Plus Receives European Regulatory Certification
The CE Mark confirms an important step toward bringing Abbott’s next-generation colorectal cancer screening technology to healthcare systems across Europe. Colorectal cancer remains a significant public health concern, and early detection can improve opportunities for effective treatment. Screening can also identify certain precancerous lesions before they develop into cancer, making participation in screening programmes an important part of cancer prevention strategies. Abbott’s Cologuard Plus test builds on the company’s experience with stool-based molecular screening and is intended to provide another option for eligible individuals. The European certification was granted under the EU’s In Vitro Diagnostic Medical Devices Regulation, which governs in vitro diagnostic tests marketed in the region. Although certification supports planned market introduction, the timing of availability will differ by country according to local requirements and healthcare systems.
At-Home DNA Testing Designed to Support Early Detection
Cologuard Plus is a noninvasive, stool-based DNA screening test that analyses multiple DNA markers and blood in a stool sample associated with colorectal cancer and advanced precancerous lesions. Individuals collect their samples at home, avoiding the bowel preparation, dietary restrictions and sedation associated with some other screening procedures. This approach is designed to make screening more convenient and may help address practical barriers that prevent people from completing recommended tests. Abbott developed Cologuard Plus in collaboration with Mayo Clinic, building on the experience of the original Cologuard test, which was introduced in the United States in 2014. The newer test incorporates novel biomarkers, improved laboratory processes and enhanced sample stability. These developments are intended to improve test performance while retaining a convenient sample-collection process. However, a positive Cologuard Plus result requires follow-up colonoscopy to determine whether colorectal cancer or advanced precancerous lesions are present. The test is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals.
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BLUE-C Study Demonstrates Strong Screening Performance
Cologuard Plus was evaluated in the BLUE-C clinical study, a prospective, multicentre investigation involving more than 20,000 participants. In the screened U.S. population, the test demonstrated 95% sensitivity for colorectal cancer at 94% specificity, according to Abbott’s announcement. The study also reported 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia, a type of precancerous abnormality with greater potential to progress to cancer. Abbott also reported up to a 40% reduction in false-positive results compared with the original Cologuard test. The BLUE-C findings were published in the New England Journal of Medicine. These performance figures come from the study population and should not automatically be assumed to represent identical results across all European populations. Clinical implementation and screening recommendations will depend on applicable regulatory requirements and local healthcare guidance. Colorectal cancer is one of the most commonly diagnosed cancers in Europe.
Abbott cited approximately 538,000 diagnoses across Europe in 2022, including more than 356,000 new cases within the European Union. The company’s European expansion plans aim to make an additional noninvasive screening option available to eligible populations. Broader access, appropriate follow-up and participation in organised screening programmes will remain important factors in translating diagnostic performance into public health benefits. For cGxP.wire, Abbott’s CE Mark announcement represents a significant MedTech and cancer diagnostics development, combining regulatory progress, clinical performance data and plans for wider access to colorectal cancer screening in Europe.
Source: Abbott press release
