The FDA has approved Exact Sciences’ Cologuard Plus test for adults 45 and older at average risk for colorectal cancer, which enhances sensitivity and reduces unnecessary follow-up procedures. Developed with Mayo Clinic, the test’s approval was based on the BLUE-C study’s results, showing high sensitivity for cancer and advanced precancerous lesions. The company plans to launch Cologuard Plus in 2025 and expects Medicare coverage and inclusion in USPSTF guidelines. Dr. Thomas F. Imperiale, the study’s principal investigator, believes the test can meaningfully improve outcomes in colorectal cancer by detecting cancer early and preventing advanced precancerous lesions.
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FDA OKs Next-Gen Cologuard Test for CRC Screening
