FDA approves Exact Sciences' Cologuard Plus, a next-gen stool DNA test for colorectal cancer screening.

The FDA has approved Exact Sciences' Cologuard Plus, a next-generation stool DNA test for colorectal cancer screening in adults aged 45 and older at average risk. Based on the BLUE-C study, the test shows 95% sensitivity for cancer and 43% for advanced precancerous lesions, with 94% specificity. Planned for launch in 2025, it aims to reduce false positives and is expected to be covered by Medicare.

October 04, 2024
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