Abbott Laboratories (NYSE: ABT), a global healthcare company, said on Tuesday that Cologuard Plus has received CE Mark approval under the European Union's In Vitro Diagnostic Medical Devices Regulation, clearing the way for its introduction in selected European markets.

Cologuard Plus is a non-invasive, stool-based DNA screening test that detects colorectal cancer and advanced precancerous lesions by analysing DNA markers and blood in stool. The test does not require bowel preparation, dietary restrictions or sedation.

Colorectal cancer remains a significant disease burden in Europe, with about 538,000 diagnoses recorded across the region in 2022. In the European Union, the disease accounted for more than 356,000 new cases, or around 13% of all new cancer diagnoses, while average screening participation across reporting EU countries was 42% within the previous two years.

The test was evaluated in the BLUE-C prospective multicentre study involving more than 20,000 participants. Among the US screening population, Cologuard Plus demonstrated 95% sensitivity for colorectal cancer detection at 94% specificity, 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia, while reducing false-positive results by up to 40% compared with the original Cologuard test.

Cologuard Plus builds on the original Cologuard test, launched in the United States in 2014, which has been used in more than 23 million screenings.