Abbott's Cologuard Plus® receives CE Mark for colorectal cancer screening in Europe
Key Highlights
- ➤Cologuard Plus receives CE Mark under Europe’s IVDR, advancing launch preparations
- ➤BLUE-C study showed 95% colorectal cancer sensitivity at 94% specificity
- ➤Cologuard Plus demonstrated 43% sensitivity for advanced precancerous lesions
- ➤Abbott plans select European launches, with timing varying by country
Expert Statements
Jake Orville, Senior vice president of Abbott's cancer diagnostics business
“Screening is one of the most powerful tools we have in the fight against colorectal cancer, but it only works when people complete it.”
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.”
Jake Orville, Senior vice president of Abbott's cancer diagnostics business
“With Cologuard Plus, we've built on that experience with even stronger performance.”
Jake Orville, Senior vice president of Abbott's cancer diagnostics business
“Receiving CE Mark is an important step toward bringing this option to more people and helping address unmet screening needs across Europe.”
Dr. Cesare Hassan, Full Professor of Gastroenterology at Humanitas University, Milan, Italy
“Colorectal cancer remains a major public-health challenge in Europe, and increasing participation in screening is an important part of addressing it.”
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.”
Abbott's Cologuard Plus® receives CE Mark for colorectal cancer screening in Europe PR Newswire
ABBOTT PARK, Ill.,, Oct. 20, 2026 * 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 PARK, Ill., , Oct. 20, 2026 /PRNewswire/ -- Abbott, a global healthcare leader, announced today 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.
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