Abbott Laboratories gains European regulatory approval for its Cologuard Plus screening test, leveraging high clinical sensitivity to expand its diagnostic footprint in the colorectal cancer detection market.
Abbott has achieved a significant regulatory milestone with the CE marking for Cologuard Plus, a non-invasive stool-based DNA screening test. This approval validates the product's efficacy, supported by the BLUE-C study which demonstrated a 95% sensitivity for detecting colorectal cancer and advanced precancerous lesions.
It is a non-invasive, stool-based DNA screening test designed to detect colorectal cancer and advanced precancerous lesions.
According to the BLUE-C study, the test demonstrated a 95% sensitivity for detecting colorectal cancer in the studied population.
Abbott Laboratories has received CE marking for its Cologuard Plus stool-based DNA screening test, marking a significant regulatory expansion into the European market. The non-invasive diagnostic tool, which demonstrated 95% sensitivity in the BLUE-C clinical trial, is designed to detect colorectal cancer and advanced precancerous lesions.
The CE marking confirms that Cologuard Plus meets European health, safety, and environmental protection standards, allowing Abbott to market and sell the diagnostic test across the European Economic Area.
In the pivotal BLUE-C study, the test achieved a 95% sensitivity rate for detecting colorectal cancer in the studied population.