Medical News Today (MNT)FDA Approves Second Blood Test to Help Close Colorectal Cancer Screening Gap

📋 Regulatory Action / Label Change

Blood-based colorectal cancer screening continues to expand following FDA authorization of a second commercially available test. The approval addresses persistent screening gaps among eligible adults who decline colonoscopy or stool-based screening despite guideline recommendations.

Clinical Considerations

• The PREEMPT CRC study enrolled more than 48,000 participants and supported FDA approval.
• SimpleScreen detected approximately 8 of 10 colorectal cancers in the clinical validation study.
• Professional societies continue to view colonoscopy and stool-based testing as preferred screening strategies.
• Positive blood-test results still require diagnostic colonoscopy to complete evaluation.

Practice Applications

• Recognize blood-based screening as an additional option for average-risk adults.
• Discuss screening preferences with patients who decline established methods.
• Interpret positive blood-test results as requiring follow-up colonoscopy.
• Consider blood-based testing within shared decision-making conversations about screening adherence.