Medical Professionals Reference (MPR)FDA Clears Cologuard Plus for Colorectal Cancer Screening

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The FDA has approved Cologuard Plus™, a next-generation multitarget stool DNA test, for colorectal cancer screening in average-risk adults aged 45 and older. This approval is based on data from the BLUE-C trial, which compared Cologuard Plus to a fecal immunochemical test (FIT) in a large study population. The trial demonstrated superior sensitivity for Cologuard Plus in detecting both colorectal cancer and advanced precancerous lesions compared to FIT, while maintaining high specificity.

Key Points:

• Cologuard Plus showed 93.9% sensitivity for colorectal cancer, compared to 67.3% for FIT.
• For advanced precancerous lesions, Cologuard Plus demonstrated 43.4% sensitivity, while FIT showed 23.3%.
• Specificity for advanced neoplasia was 90.6% for Cologuard Plus and 94.8% for FIT.
• The BLUE-C trial included 20,176 participants, with colonoscopy results used as the reference standard.
• Colorectal cancer was detected in 0.5% of participants, while 10.6% had advanced precancerous lesions.
• Cologuard Plus features novel biomarkers and enhanced sample stability components.
• The test is expected to be available for clinical use sometime next year.

“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early – when it is most treatable – and find advanced precancers, which can prevent cases of this cancer.”
— Thomas F. Imperiale, MD, Professor of Medicine at the Indiana University School of Medicine

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