October 20, 2026- Abbott 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.