Abbott Wins CE Mark for Cologuard Plus Colorectal Cancer Test

Abbott announced on October 20, 2026, from Abbott Park, Illinois, that the Cologuard Plus test has received CE Mark under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR), and that it plans to introduce the noninvasive, stool-based DNA screening test in select European markets.

Cologuard Plus is designed to detect both colorectal cancer and advanced precancerous lesions. The test analyzes DNA markers and blood in stool associated with colorectal cancer and precancer, and does not require bowel preparation, dietary restrictions or sedation.

Patients collect the stool sample at home. For the sample-collection process, patients do not need bowel preparation, dietary changes, sedation, or time away from work or other activities. The test is indicated to screen adults aged 45 years or older who are at average risk for colorectal cancer. A positive result may indicate the presence of colorectal cancer or advanced precancerous lesions and should be followed by a colonoscopy. Abbott states the test is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

“Screening is one of the most powerful tools we have in the fight against colorectal cancer, but it only works when people complete it,” said Jake Orville, senior vice president of Abbott’s cancer diagnostics business. Orville said Cologuard has helped transform colorectal cancer screening in the United States by giving people an effective, convenient option they can complete at home, and that Cologuard Plus builds on that experience with even stronger performance. He described the CE Mark as an important step toward bringing the option to more people and helping address unmet screening needs across Europe.

Colorectal Cancer Burden and Screening Participation in Europe

Colorectal cancer is one of the most commonly diagnosed cancers in Europe, according to the announcement. Citing the GLOBOCAN 2022 database from the International Agency for Research on Cancer, Abbott said approximately 538,000 people across Europe were diagnosed with the disease in 2022. Within the European Union, colorectal cancer accounted for more than 356,000 new cases, or approximately 13% of all new cancer diagnoses, according to figures from the European Commission’s European Cancer Information System cited in the announcement.

The announcement states that screening can identify colorectal cancer earlier, when treatment may be more effective, and can also identify certain precancerous lesions before they progress to cancer. It notes that participation in colorectal cancer screening varies considerably across Europe. In 2022, an average of 42% of people in the target age group across reporting EU countries participated in colorectal cancer screening within the previous two years, according to the OECD/European Commission Health at a Glance: Europe 2024 report cited by the company.

Dr. Cesare Hassan, Full Professor of Gastroenterology at Humanitas University in Milan, Italy, said colorectal cancer remains a major public-health challenge in Europe and that increasing participation in screening is an important part of addressing it. “Expanding access to accurate, noninvasive screening options that people are willing to complete could help identify more cancers earlier and detect advanced precancerous lesions before they progress,” he said.

Clinical Performance in the BLUE-C Study

Cologuard Plus was evaluated in BLUE-C, a prospective, multicentre study of more than 20,000 participants that the announcement describes as one of the largest prospective studies of colorectal cancer screening. Results from the BLUE-C study were published in the New England Journal of Medicine.

Among the U.S. screening population, Cologuard Plus demonstrated 95% sensitivity for colorectal cancer detection at 94% specificity, the announcement states, citing the Cologuard Plus Clinician Brochure from Exact Sciences Corporation. The test showed 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia, described in the announcement as the type of precancerous lesion most likely to progress to cancer. Citing data on file at Exact Sciences Corporation, the announcement also reports up to a 40% reduction in false-positive results compared with the original Cologuard test. A footnote states that the 94% specificity figure was determined among adults with no colorectal neoplasia and age-weighted to the U.S. population.

According to the company, Cologuard Plus incorporates novel biomarkers and improvements to laboratory processes and sample stability, building on more than a decade of experience with the original Cologuard test. The first version of Cologuard was launched in the United States in 2014 and has been used for more than 23 million screenings. Both tests were developed in collaboration with Mayo Clinic, and Cologuard and Cologuard Plus are trademarks of the Abbott group of companies.

Abbott said it plans to introduce Cologuard Plus in select European markets, with the timing and availability of the test varying by country based on local healthcare pathways, reimbursement and operational readiness.