Geneoscopy Gains FDA Approval for Simpler At-Home CRC Test with Updated ColoSense Kit

Geneoscopy has received FDA approval for a new, simplified stool collection method for its RNA-based ColoSense® colorectal cancer (CRC) screening test. The revised kit eliminates the need to divide the stool sample into multiple containers, addressing a key barrier to patient compliance with at-home testing. This streamlined approach maintains the test’s clinical accuracy while offering a more user-friendly experience.

ColoSense is designed for average-risk adults aged 45 and older and uses RNA biomarker detection to identify colorectal cancer and advanced adenomas. It remains the only FDA-approved RNA-based CRC screening tool and has demonstrated 93% sensitivity for CRC and 45% for advanced adenomas in average-risk populations. Notably, in individuals aged 45–49, ColoSense showed 100% sensitivity for CRC.

With an estimated 44 million Americans aged 45–75 still unscreened, improving ease of use is critical. Geneoscopy expects the new kit to reduce collection errors, lower invalid test rates, and ultimately drive higher participation. By removing the most confusing and unpleasant step—scraping the stool sample—the test improves accessibility and may help close a persistent screening gap.

The ColoSense test is included in the National Comprehensive Cancer Network (NCCN) guidelines and will be distributed nationally through Geneoscopy’s partnership with Labcorp. The enhanced test underscores the importance of patient-centered innovation in advancing early cancer detection and public health outcomes.