Modeling Study Published in Clinical Gastroenterology and Hepatology Validates Geneoscopy’s ColoSense® Real-World Screening Impact

ST. LOUIS--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced the publication of a new study in Clinical Gastroenterology and Hepatology showing that its FDA-approved multitarget stool RNA (mt-sRNA) test, ColoSense®, achieved notable clinical benefits among colorectal cancer (CRC) screening tests when modeled at real-world adherence levels.

In the absence of a head-to-head study comparing CRC screening options, this peer-reviewed modeling study, titled “Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia,” provides valuable insights by evaluating five CRC screening strategies for patients aged 45 and older. Using a 10-year Markov model, researchers simulated disease progression, comparing mt-sRNA, two mt-sDNA tests, a blood-based test, and a fecal immunochemical test (FIT), and reported findings similar to previously published modeling studies.^1-3 When test performance was normalized to better reflect the age of the intended use population, the clinical and economic benefits of ColoSense were amplified.

At real-world adherence of 60% (the typical rate observed in practice), the modeling study results showed that ColoSense reduced CRC deaths by 14% compared to FIT, by 19% and 23% compared to the mt-sDNA tests, and by 86% compared to a blood-based test.¹ While FIT remained the most cost-effective strategy overall, ColoSense was the most cost-effective among molecular tests across all levels of screening adherence.

“Study cohorts often don’t reflect the target patient population, which can skew results and limit clinical relevance,” said Dr. Erica Barnell, co-author and Chief Science and Medical Officer at Geneoscopy. “These data reinforce the need to design studies around real-world populations. ColoSense was developed with that in mind, delivering strong performance across diverse groups, including younger adults who are often under-represented in clinical trials.”

This study builds on prior research by using a model that normalizes the age of the populations in independent, peer-reviewed studies to better reflect the general screening population. Given that many assays rely on methylation-based biomarkers, whose sensitivity is lower in younger individuals,^4,5 adjusting sensitivity estimates for colorectal cancer and advanced adenomas is essential for accurate clinical and economic assessment.

ColoSense is included in the 2025 National Comprehensive Cancer Network (NCCN) guideline update, highlighting the strength of its clinical evidence and the robust science behind Geneoscopy’s RNA-based approach. As the only FDA-approved stool RNA test for CRC screening, ColoSense represents a significant step forward in noninvasive screening methods, underscoring the need for accessible alternatives that can increase compliance, especially among groups less likely to pursue colonoscopy.

*All data used in the study were derived from independent, non-head-to-head clinical trial results.

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) in October 2023. 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. Shaukat A, Levin TR, Liang PS, Weiss JM, Smare C, Boller E, Venkatachalam M, Barnell EK. Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia. Clinical Gastroenterology and Hepatology. 2025. doi: https://doi.org/10.1016/j.cgh.2025.06.006.
2. Ladabaum U, Mannalithara A, Schoen RE, Dominitz JA, Lieberman D. Projected impact and cost-effectiveness of novel molecular blood-based or stool-based screening tests for colorectal cancer. Ann Intern Med. 2024;177(12):1610-1620. doi: 10.7326/ANNALS-24-00910. Epub 2024 Oct 29. PMID: 39467291.
3. Rui M, Wang Y, You JH. Novel non-invasive tests for colorectal cancer screening - a cost-effectiveness analysis. Cancer Epidemiol Biomarkers Prev. 2025;OF1–OF11. doi:10.1158/1055-9965.EPI-24-1549.
4. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, Boardman LA, Thibodeau SN, et al. Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research. 2012;72(8_Supplement):3572–3572. https://doi.org/10.1158/1538-7445.am2012-3572.
5. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. Aberrantly methylated gene marker levels in stool: effects of demographic, exposure, body mass, and other patient characteristics. J Mol Biomark Diagn. 2012;3:133. doi:10.4172/2155-9929.1000133.