Labcorp Launches ColoSense, an RNA-Based At-Home Colon Cancer Test
Labcorp has launched ColoSense, the first FDA-approved, RNA-based at-home screening test for colorectal cancer. Developed in partnership with Geneoscopy, the diagnostic tool aims to boost screening participation by simplifying the collection process, addressing discomfort and complexity that often deter patients from completing traditional at-home testing.
Colorectal cancer remains highly preventable through early detection, yet nearly 40% of eligible adults remain unscreened. Many patients cite the messy and complicated nature of existing stool-based kits as a primary barrier to compliance. Labcorp designed ColoSense to solve these logistical hurdles, offering a streamlined kit that eliminates the need for users to mix or manually separate samples.
The test identifies biomarkers linked to colorectal cancer and advanced adenomas using proprietary RNA technology. Clinical performance data shows 93% sensitivity for colorectal cancer in average-risk adults, with a 100% sensitivity rate for stage I disease. The test is now available nationwide for patients aged 45 to 85. It has earned coverage from Medicare and Medicare Advantage, following a recent update to the National Coverage Determination by the Centers for Medicare & Medicaid Services.
Dr. Brian Caveney, chief medical and scientific officer at Labcorp, noted that the platform aligns with guidelines from the American Cancer Society and the National Comprehensive Cancer Network. While ColoSense is intended for average-risk individuals, it is not a replacement for a diagnostic colonoscopy. If a patient receives a positive result, they are expected to undergo follow-up procedures to confirm findings and determine the necessary clinical path.
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