DiaCarta’s iColon Fecal Occult Blood Test, an over-the-counter product, has received FDA 510(k) clearance. This test enables early at-home detection of blood in stool, a key indicator of gastrointestinal disorders and colorectal cancer. It complements DiaCarta’s existing ColoScape test, which identifies colorectal cancer-associated mutations and methylation biomarkers in circulating blood to assess high-risk patients for colorectal cancer.
Key Insights:
- Enhanced Accessibility for Early Detection: The iColon test’s over-the-counter availability makes early detection of potential colorectal issues more accessible to the general public.
- Comprehensive Screening Approach: By complementing the ColoScape test, DiaCarta offers a more holistic approach to colorectal cancer screening, covering both genetic biomarkers and occult blood detection.
- Potential for Improved Outcomes: Early detection through such non-invasive tests can lead to timely intervention, potentially improving patient outcomes in colorectal cancer and other gastrointestinal disorders.