Abbott's Cologuard Plus® Receives CE Mark for Colorectal Cancer Screening in Europe
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ABBOTT PARK, Ill., October 20, 2026 / PRNewswire / -- Abbott, a global healthcare leader, announced today that the Cologuard Plus® test has received the CE mark under the European Union's In Vitro Diagnostic Medical Devices Regulation (IVDR), representing a major step toward making this non-invasive colorectal cancer screening test available in Europe. Cologuard Plus is a DNA-based test designed to detect both colorectal cancer and advanced precancerous lesions. The test analyzes stool DNA and blood markers associated with colorectal cancer and precancerous lesions, and requires no bowel preparation, dietary restrictions, or sedation. The CE mark represents a very important regulatory milestone within Abbott's plans to bring Cologuard Plus to Europe. Abbott plans to introduce the test in selected European markets, and availability and timing of launch will vary by country, depending on local health systems, reimbursement, and operational readiness. "Early detection is one of the most powerful tools we have in the fight against colorectal cancer, but it only works when people actually do it," noted Jake Orville, senior vice president of Abbott's oncology diagnostics business. "Cologuard has helped transform early detection of colorectal cancer in the United States, offering people an effective and convenient option they can do in their own home. Thanks to Cologuard Plus, we...
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