Abbott Secures CE Mark for Cologuard Plus® Colorectal Cancer Screening Test
- Cologuard Plus is a noninvasive, stool-based DNA screening test designed to detect both colorectal cancer and advanced precancerous lesions
- In the pivotal BLUE-C study, Cologuard Plus demonstrated 95% sensitivity for colorectal cancer at 94% specificity in the screened population
- CE Mark is an important regulatory milestone as Abbott prepares to introduce Cologuard Plus in select European markets, with timing and availability varying by country
Abbott has announced that the Cologuard Plus® test has received CE Mark under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR), marking an important step toward making the noninvasive colorectal cancer screening test available in Europe.
Cologuard Plus is a DNA test 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.
The CE Mark represents an important regulatory milestone in Abbott plans to bring Cologuard Plus to people in Europe. Abbott plans to introduce the test in select European markets, with the timing and availability varying by country based on local healthcare pathways, reimbursement and operational readiness.
“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. “Cologuard has helped transform colorectal cancer screening in the United States 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.”
Addressing a Significant Cancer Burden in Europe
Colorectal cancer is one of the most commonly diagnosed cancers in Europe. In 2022, approximately 538,000 people across Europe were diagnosed with the disease.1 Within the European Union, colorectal cancer accounted for more than 356,000 new cases, or approximately 13% of all new cancer diagnoses.2
Screening can identify colorectal cancer earlier, when treatment may be more effective, and can also identify certain precancerous lesions before they progress to cancer. Yet 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.3
“Colorectal cancer remains a major public-health challenge in Europe, and increasing participation in screening is an important part of addressing it,” said Dr. Cesare Hassan, Full Professor of Gastroenterology at Humanitas University, Milan, Italy. “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.”
How Cologuard Plus Screens For Colorectal Cancer
Cologuard Plus uses a stool sample that patients collect at home. The test analyses multiple DNA markers and blood in the stool associated with colorectal cancer and advanced precancerous lesions. For the sample-collection process, patients do not need bowel preparation, dietary changes, sedation, or time away from work or other activities.
Clinical Performance Demonstrated in the BLUE-C Study
Cologuard Plus was evaluated in BLUE-C, a prospective, multicentre study of more than 20,000 participants and one of the largest prospective studies of colorectal cancer screening.
Among the U.S. screening population, Cologuard Plus demonstrated:
- 95% sensitivity for colorectal cancer detection at 94% specificity4
- 43% sensitivity for advanced precancerous lesions4
- 74% sensitivity for high-grade dysplasia, the type of precancerous lesion most likely to progress to cancer4
- Up to a 40% reduction in false-positive results compared with the original Cologuard test.5
Results from the BLUE-C study were published in the New England Journal of Medicine.
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.
- Ferlay J, et al. Global Cancer Observatory: Cancer Today. International Agency for Research on Cancer. GLOBOCAN 2022.
- European Commission, European Cancer Information System. Colorectal cancer prevention: prevalence and incidence in the European Union.
- OECD/European Commission. Health at a Glance: Europe 2024: State of Health in the EU Cycle. Cancer screening. 2024. OECD – Health at a Glance: Europe 2024
- Cologuard Plus Clinician Brochure. Exact Sciences Corporation.
- Data on file. Exact Sciences Corporation.
*94% specificity was determined among adults with no colorectal neoplasia and age-weighted to the U.S. population.
NOTE: Cologuard and Cologuard Plus are trademarks of the Abbott group of companies
For further information: Abbott Media: Veronika Bendere +41 78 351 30 80 | Abbott Financial: Michael Comilla, (224) 668-1872
Source: Abbott’s Cologuard