ST. LOUIS — Geneoscopy, Inc., a life sciences company focused on advancing gastrointestinal health through diagnostic innovation, announced new peer-reviewed data in Practical Laboratory Medicine validating the analytical reliability of the scrape-free collection method used in its ColoSense colorectal cancer (CRC) screening test. The method, which removes the need for patients to handle stool samples and standardizes testing in the laboratory, will be featured at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting on Monday, October 27, 2025.
The study, titled “Analytical validation of a scrape-free multitarget stool RNA test for colorectal cancer screening,” evaluated the fecal immunochemical test (FIT) component of Geneoscopy’s FDA-approved ColoSense test. In testing across more than 1,300 replicates, ColoSense demonstrated high reliability and reproducibility under a variety of simulated and real-world conditions, including differences in stool volume, dietary factors, freeze-thaw cycles, and shipping times of up to 120 hours. A prospective clinical equivalency analysis showed 94 percent agreement between the in-lab FIT and traditional at-home FIT methods. In retrospective testing, the in-lab FIT achieved high sensitivity for detecting colorectal cancer and advanced adenomas, matching established performance benchmarks.
“Accurate, patient-friendly collection methods are essential to improving participation in colorectal cancer screening,” said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer at Geneoscopy and lead author of the study. “Our continued research reinforces that simplifying the collection process can enhance accuracy while reducing barriers that often limit screening completion. We look forward to sharing our latest developments at ACG.”
ColoSense uses an FDA-approved, no-touch, single-sample collection system that enables patients to send stabilized stool samples directly to the laboratory. Trained technicians then perform all analyses under controlled conditions, ensuring consistent results and reducing variability often associated with at-home testing. This scrape-free, standardized process aims to make colorectal cancer screening more accessible, reliable, and patient-friendly.
