After Cologuard first debuted more than 10 years ago, the new version of the stool test with at-home sample collection brings a refined slate of genetic biomarkers, which the company says cuts its rate of false positives.
First developed through a collaboration with the Mayo Clinic, the test was acquired through the company’s $21 billion buyout of Exact Sciences last year, which also brought the tissue- and blood-based cancer diagnostics Oncotype Dx, Cancerguard and Oncodetect into Abbott’s fold.
With a CE Mark under the European Union’s In Vitro Diagnostic Regulation, Abbott says it now plans to begin introducing Cologuard Plus in select European markets, with timings based on reimbursement availability and local readiness. The test was approved in the U.S. in 2024.
“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 VP of Abbott’s cancer diagnostics business, said in a statement. “Receiving CE Mark is an important step toward bringing this option to more people and helping address unmet screening needs across Europe.”
Abbott estimates that colorectal tumors account for about 13% of all new cancer diagnoses in the E.U., or about 356,000 cases. The company also noted that a 2022 study found an average of 42% of people in the target age group had completed recommended colorectal cancer screening within the prior two years.
The noninvasive DNA test, which does not require bowel preparation, dietary restrictions or sedation, is designed to funnel users toward a confirmatory colonoscopy following a positive result.
The test’s large-scale pivotal study showed 95% sensitivity and 94% specificity for colorectal cancer among 20,000 participants; it was less accurate for the detection of precancerous lesions and high-grade dysplasia.
