Abbott's non-invasive colon cancer screening test Cologuard Plus has received CE marking under the EU In Vitro Diagnostic Regulation (IVDR). As the company announced, this is an important regulatory step to make the stool-based DNA test available in Europe. Abbott is preparing for launch in selected European markets; timing and availability will vary by country, depending on supply chains, reimbursement, and operational readiness.
Cologuard Plus analyzes DNA markers and blood in stool associated with colorectal cancer and advanced precancerous lesions. The test requires no bowel preparation, dietary restrictions, or sedation. In the pivotal BLUE-C study with more than 20,000 participants, Cologuard Plus showed 95 percent sensitivity for colorectal cancer with 94 percent specificity in the US screening population. Sensitivity for advanced precancerous lesions was 43 percent, and for high-grade dysplasia, it was 74 percent. The rate of false-positive results decreased by up to 40 percent compared to the original Cologuard test. The results were published in the "New England Journal of Medicine."
Jake Orville, senior vice president of Abbott's diagnostics business, said early detection is one of the most effective tools against colon cancer, but it only works if people use it. Cologuard has changed screening in the U.S. through an effective and convenient at-home application; Cologuard Plus builds on this and enhances performance. The CE marking is an important step to make this option accessible to more people and address the unmet need for screening in Europe.
Colorectal cancer is among the most commonly diagnosed cancers in Europe. In 2022, approximately 538,000 people in Europe were diagnosed with the disease; in the EU, more than 356,000 new cases were attributed to colorectal cancer, around 13 percent of all new cancer diagnoses. Participation in screening varies widely, according to the announcement: in 2022, an average of 42 percent of people in the target age group in reporting EU countries participated within the last two years. Gastroenterologist Cesare Hassan of Humanitas University in Milan said broader access to precise, non-invasive screening options that people are willing to undertake could help detect more cancers earlier and identify advanced precursors.
Cologuard Plus is indicated for adults 45 years and older at average risk for colorectal cancer and uses a stool sample collected at home. A positive result should be followed up with a colonoscopy; the test does not replace a diagnostic or surveillance colonoscopy in people at high risk. Cologuard and Cologuard Plus were developed with the Mayo Clinic. The first version of Cologuard was launched in the U.S. in 2014 and has been used in more than 23 million screening exams, according to the company. Abbott has about 122,000 employees in more than 160 countries.
