Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today 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 eliminates patient handling of stool and standardizes testing in the laboratory, will be highlighted at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting on Monday, Oct. 27, 2025.

The recently published study, “Analytical validation of a scrape-free multitarget stool RNA test for colorectal cancer screening,” evaluated the fecal immunochemical test (FIT) component used with Geneoscopy’s FDA-approved ColoSense screening test. Across more than 1,300 replicates, ColoSense demonstrated high reliability and reproducibility under a range of simulated and real-world scenarios, including variable stool volumes, common dietary interferences, freeze-thaw cycles, and in-transit times up to 120 hours. A prospective, clinical equivalency analysis showed 94% agreement between results from the in-lab FIT and those from traditional at-home FIT.¹ Additionally, in retrospective testing, the in-lab FIT achieved high sensitivity for colorectal cancer and advanced adenomas, consistent with established performance benchmarks.¹

“Accurate, patient-friendly collection methods are essential to improving participation in colorectal cancer screening,” said Erica Barnell, MD, PhD, 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 utilizes an FDA-approved, no-touch, single-sample collection process that allows patients to send a stabilized stool sample directly to the laboratory, where trained technicians perform all analyses under controlled conditions. This standardized approach reduces variability, ensures consistent results, and eliminates issues associated with at-home FIT collection.

Geneoscopy will be available to discuss ColoSense and its clinical research at Booth #565 during ACG 2025. The company’s poster, P2612 (Category: Colon Cancer), will be presented in the Exhibit Hall on Oct. 27, 2025, from 10:30 a.m. to 4:00 p.m. PDT. Additional information is available through the ACG 2025 Poster Program.

About ColoSense

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.

A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA). For more information, visit www.colosense.com.

About Geneoscopy, Inc.

Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

References

1. Barnell EK, Kruse K, Wurtzler EM, Scott MC, Barnell AR, Duncavage EJ. Analytical validation of a scrape-free multitarget stool RNA test for colorectal cancer screening. Practical Laboratory Medicine. 2025;47:e00502. https://doi.org/10.1016/j.plabm.2025.e00502

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