Molecular diagnostics company Exact Sciences Corp. (NASDAQ:EXAS) announced on Friday that it has received FDA approval for its next-generation multitarget stool DNA test, Cologuard Plus.
This test is approved for adults aged 45 and older at average risk for colorectal cancer (CRC). Approval followed findings from the pivotal BLUE-C study, one of the largest prospective studies in CRC screening, involving nearly 19,000 participants.
Cologuard Plus demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no colonoscopy findings. Additionally, it significantly outperformed an independent fecal immunochemical test in various sensitivity metrics.
CRC, often preventable yet frequently undetected, remains the second deadliest cancer in the US Cologuard Plus builds on the success of the original Cologuard test, which has been utilized over 17 million times. Launching in 2025, the test will leverage Exact Sciences' commercial organization and ExactNexus technology platform, ensuring seamless integration for over 350 health systems.
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