CMS Grants Medicare Coverage for ColoSense®, Expanding Access to Simplified Noninvasive Colorectal Cancer Screening

Medicare coverage will provide approximately 65 million eligible Medicare beneficiaries access to the first FDA-approved colon cancer screening stool-RNA test

ST. LOUIS--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved coverage for FDA-approved ColoSense, a stool-based colorectal (CRC) screening test, within the National Coverage Determination (NCD) for colorectal cancer screening tests.

Coverage for ColoSense provides Medicare's approximately 65 million eligible beneficiaries with access to the first FDA-approved, high-sensitivity stool-RNA test that addresses one of the most commonly cited barriers to stool-based screening: the need to handle the sample during collection.¹ ColoSense requires only three simple steps, with no stool scraping required, eliminating the need for patients to manipulate the stool sample, while maintaining clinical performance for detection of colorectal cancer and advanced adenomas.

Forward-Thinking Coverage Framework Supports Innovation

The updated National Coverage Determination (NCD) for CRC screening also establishes a framework that supports future innovations, including new or improved RNA-based assays.

"We applaud CMS for revising the NCD for CRC screening tests in a way that is forward-thinking and allows for new innovation in this area of testing," said Geneoscopy CEO, Andrew Barnell. “Restructuring the CRC Screening NCD to include high-sensitivity tests like ColoSense demonstrates the importance that CMS places on earlier detection of colorectal cancer through preventive screening. This new framework ensures that Medicare beneficiaries will have timely access to innovative screening technologies that receive FDA approval."

In average-risk patients, ColoSense is 93% sensitive for CRC and 45% sensitive for advanced adenomas, with consistent performance across age groups.¹ Notably, ColoSense showed 100% sensitivity for stage I cancer,^* detecting CRC at its most treatable stage when the five-year survival rate is approximately 90%.^1,2

CMS coverage aligns with current NCCN and ACS guidelines, which recommend ColoSense as a preferred screening option with a three-year testing interval for average-risk adults aged 45 to 85.

Addressing Critical Gaps in Colorectal Cancer Screening for Medicare Patients

Despite improvements in colorectal cancer incidence within the Medicare population, more than half of all colorectal cancer diagnoses still occur in patients 65 and older.³

CMS coverage for ColoSense provides Medicare beneficiaries with an additional, guideline-endorsed screening option that removes common barriers to test completion. “With such a high percentage of new cancer diagnoses still occurring in the Medicare population, it was critical for CMS to expand coverage to include new, non-invasive tests,” added Barnell. “The addition of a new, high-sensitivity stool test like ColoSense, with a simplified specimen collection methodology that eliminates the need for patients to manipulate the stool sample, can make at-home screening easier for the 65 and older population. A simple testing process is important for Medicare beneficiaries, who may demonstrate limited dexterity or lower health literacy.”⁴

A strategic collaboration with Labcorp will further expand access to ColoSense, enabling broader provider and patient adoption through Labcorp’s nationwide network. The ColoSense experience includes a structured patient support process that engages ColoSense recipients throughout the CRC screening continuum: from the point of order and sample collection, through navigation support to colonoscopy for patients with positive/abnormal results. Providers can customize the level and type of support that their patients receive.

*12/12 patients, 95% CI 74%-100%

About ColoSense

ColoSense is the first and only FDA-approved stool-based RNA test for colorectal cancer screening. The test is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool.

ColoSense is indicated as a screening test for adults aged 45 years or older who are at average risk for developing CRC and is included in NCCN and ACS guidelines with a recommended three-year testing interval.¹ ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

A positive ColoSense result may indicate the presence of colorectal cancer, advanced adenomas, or serrated precancerous lesions and should be followed by a colonoscopy. ColoSense is a single-site test performed at Geneoscopy's CLIA-certified laboratory.

Results from Geneoscopy's pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA).⁵ For more information, visit www.colosense.com.

About Geneoscopy, Inc.

Geneoscopy is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA 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 an RNA-based platform to screen for colorectal cancer and advanced adenomas in average-risk individuals 45 years of age or older. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is developing diagnostic tests for treatment selection and therapy monitoring. For more information, visit www.geneoscopy.com.

References

1. ColoSense Clinician Brochure, St. Louis, MO, Geneoscopy, Inc.
2. American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025. Atlanta: American Cancer Society; 2023.
3. Siegel RL, Wagle NS, Jemal A. Leading Cancer Deaths in People Younger Than 50 Years. JAMA. 2026;335(3):e2525467. doi:10.1001/jama.2025.25467
4. Liu PH, Nair RG, Skinner CS, et al. Unsatisfactory fecal immunochemical tests for colorectal cancer screening: prevalence, reasons, and subsequent testing. Cancer Epidemiol Biomarkers Prev. 2024;33(2):215-223. doi:10.1158/1055-9965.EPI-23-0507
5. Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023;330(18):1760-1768. doi:10.1001/jama.2023.22231