Abbott Laboratories said its Cologuard Plus test received a CE Mark under the European Union’s regulations for in vitro diagnostic devices. The certification is a key step toward making the noninvasive colorectal cancer screening test available to patients across Europe.
Cologuard Plus analyzes DNA markers and blood in a stool sample to detect colorectal cancer and advanced precancerous lesions.
In the supporting BLUE-C study, the test showed 95% sensitivity for colorectal cancer. Its specificity was 94%.
The timing of a commercial launch will depend on reimbursement and approval processes in individual countries.