Indiana University School Of Medicine

FDA approves Cologuard Plus, a noninvasive stool DNA test for CRC screening in adults 45+ at average risk, with 95% cancer sensitivity and 43% for advanced precancerous lesions. The BLUE-C study supported its efficacy. In May 2024, FDA also approved ColoSense, another noninvasive stool test for early CRC detection in patients 45+, showing 93% sensitivity for CRC and 100% for stage I CRC.

The US FDA approved Cologuard Plus, a multitarget stool DNA test for CRC screening in adults aged 45+, reducing false positives by over 30%. The test showed 93.9% sensitivity for CRC and 90.6% specificity for advanced neoplasia, outperforming fecal immunochemical testing (FIT) in detecting CRC and advanced precancerous lesions. Cologuard Plus is set to launch with Medicare coverage in 2025.

FDA approves Cologuard Plus™ for colorectal cancer screening in adults aged 45+. Cologuard Plus, a next-gen multitarget stool DNA test, showed 93.9% sensitivity for colorectal cancer and 90.6% specificity for advanced neoplasia in the BLUE-C trial. Expected availability in 2025.

The FDA approved Cologuard Plus, a multitarget stool DNA test for CRC screening in adults 45+ at average risk. The BLUE-C trial showed 93.9% overall CRC sensitivity and 90.6% specificity for advanced neoplasia, outperforming an independent FIT in sensitivity for CRC and advanced precancerous lesions. Cologuard Plus aims to improve early CRC detection and reduce false positives.

FDA approves Exact Sciences' Cologuard Plus test for CRC screening in adults ≥ 45, based on BLUE-C study results showing 95% cancer sensitivity and 43% precancerous lesion sensitivity at 94% specificity. The test outperformed an independent FIT in multiple metrics, with plans for Medicare coverage and guideline inclusion in 2025.

The FDA approved Exact Sciences’ Cologuard Plus, a multitarget stool DNA test for colorectal cancer screening in adults aged 45 or older. The next-generation test uses novel biomarkers and improved processes, enhancing sensitivity and specificity over the original Cologuard. Data from the BLUE-C trial showed Cologuard Plus outperformed FIT in detecting CRC and precancerous lesions, with a 30% reduction in false positives. The test is expected to launch in 2025.

The FDA approved the Cologuard® Plus test, a next-gen multitarget stool DNA test for CRC screening in individuals 45+ at average risk. The test uses new biomarkers and enhanced lab processes, with improved sample stability, allowing a larger window for sample return. It yielded a 93.9% sensitivity rate for CRC and 90.6% specificity for advanced neoplasia. The Cologuard Plus test is expected to launch with Medicare coverage in 2025.

FDA approves Cologuard Plus™ test, offering 95% sensitivity for colorectal cancer and 43% for advanced precancerous lesions at 94% specificity, aiming to reduce unnecessary colonoscopies. Expected launch with Medicare coverage in 2025.