Geneoscopy, Inc., a life sciences company advancing gastrointestinal diagnostics, has received FDA approval for an updated stool collection kit for ColoSense®, its RNA-based colorectal cancer (CRC) screening test. The newly approved kit eliminates the need for patients to separate stool samples into multiple containers—significantly simplifying the at-home testing process while maintaining clinical performance.
“This is a critical step toward improving the at-home CRC screening experience,” said Dr. Erica Barnell, Chief Medical & Science Officer at Geneoscopy. “By removing the need to scrape stool—a major source of confusion and discomfort—we’ve made the collection process more user-friendly and accessible, which we believe will boost adherence and improve health outcomes.”
ColoSense is FDA-approved for adults aged 45 and older at average risk for colorectal cancer. Utilizing RNA biomarker detection, the test identifies both colorectal cancer and advanced adenomas (AA)—precancerous lesions that can progress to cancer if untreated. It is currently the only FDA-approved RNA-based screening test for CRC.
In clinical studies, ColoSense demonstrated:
93% sensitivity for CRC
45% sensitivity for advanced adenomas
100% sensitivity for CRC among average-risk individuals aged 45–49, a group experiencing rising incidence rates
Despite the availability of multiple screening tools, an estimated 44 million Americans aged 45–75 remain unscreened for colorectal cancer. By eliminating the most burdensome aspect of stool collection, the new kit is expected to improve patient compliance, reduce sample collection errors, and minimize invalid results—ultimately leading to fewer missed screenings and broader population-level impact.
“To achieve over 80% compliance in CRC screening, we must enhance the patient experience,” said Andrew Barnell, CEO of Geneoscopy. “ColoSense delivers high sensitivity with the convenience of at-home testing—and now with an easier, more intuitive sample collection process.”
ColoSense is included in the National Comprehensive Cancer Network (NCCN) guidelines, reflecting the strength of its clinical data and innovative RNA-based science. The test is available through Geneoscopy’s strategic collaboration with Labcorp, ensuring wide access for both patients and healthcare providers across the U.S.
This update reinforces ColoSense as a leading noninvasive alternative to colonoscopy and highlights the importance of simplifying screening tools to reach underserved and reluctant populations.