Abbott’s Cologuard Plus test has received CE Mark under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR).
In an Oct. 20 statement, Abbott said it plans to introduce the test in select European markets, with timing and availability varying by country based on local healthcare pathways, reimbursement, and operational readiness. The company did not provide either a list of countries or potential launch dates.
Cologuard Plus is a stool-based DNA test that analyzes biomarkers associated with colorectal cancer and advanced precancerous lesions. Abbott acquired the test via its $21 billion purchase of Exact Sciences, which closed earlier this year.
“Cologuard has helped transform colorectal cancer screening in the US by giving people an effective, convenient option they can complete at home,” Jake Orville, senior VP of Abbott’s cancer diagnostics business, said in a statement. “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.”
According to Abbott, there were approximately 350,000 colorectal cancer diagnoses in the EU in 2022 and participation in screening varies widely.