ST. LOUIS — Geneoscopy, Inc. has received FDA approval for a new stool collection method for its ColoSense® test, a noninvasive RNA-based colorectal cancer (CRC) screening tool. The updated kit simplifies the sample collection process by eliminating the need for patients to divide their stool into multiple containers—a common deterrent to at-home testing.
“We’ve taken a critical step toward improving the at-home colorectal cancer screening experience by removing one of the most burdensome aspects for patients—the scraping of stool,” said Dr. Erica Barnell, Chief Medical & Science Officer of Geneoscopy. “By eliminating the most confusing and undesirable step, we believe ColoSense will drive higher adherence and better outcomes.”
ColoSense is the only FDA-approved RNA-based screening test for CRC and is indicated for average-risk individuals aged 45 and older. The test detects RNA biomarkers associated with colorectal cancer and advanced adenomas (AA). Clinical data showed ColoSense achieved 93% sensitivity for CRC and 45% for AA in the general 45+ population. Notably, it demonstrated 100% sensitivity for CRC and 44% for AA among individuals aged 45 to 49—a group experiencing a rising incidence of the disease.
An estimated 44 million Americans aged 45 to 75 remain unscreened for colorectal cancer, despite multiple testing options. Geneoscopy aims to boost screening rates by addressing one of the most significant barriers: the collection process. The simplified kit reduces collection errors and lowers the risk of invalid samples, making the experience more accessible and user-friendly.
“To exceed 80% compliance for colorectal cancer screening, the patient experience for stool-based screening must be improved,” said Andrew Barnell, CEO of Geneoscopy. “The new ColoSense test does that, offering patients everything they like about at-home, high-sensitivity screening, but now, with an easier collection process.”
ColoSense is included in the National Comprehensive Cancer Network (NCCN) guidelines and will be available nationwide through Geneoscopy’s partnership with Labcorp. The innovation is expected to expand access to CRC screening and offer a meaningful alternative to colonoscopy for patients who may otherwise forgo testing.
