CMS Final Colorectal Screening Decision Adds Geneoscopy's ColoSense Stool RNA Test

The Centers for Medicare & Medicaid Services has finalized a revised national coverage determination for colorectal cancer screening that brings stool RNA testing into Medicare coverage, with Geneoscopy saying its ColoSense test now qualifies. CMS posted the final decision memorandum for the reconsideration, "Screening for Colorectal Cancer-Non-Invasive Biomarker Tests" (CAG-00440R), on June 8.

The memo says the reconsideration of NCD 210.3 was externally initiated by Geneoscopy. CMS opened the analysis in September 2025, posted a proposed decision on March 10, 2026, and received 95 comments in the second comment period before issuing the final decision.

Performance thresholds replace product-specific rules

Under the decision, non-invasive biomarker screening tests are covered once every three years for people aged 45 to 85 who have no symptoms of colorectal disease and are at average risk. The test must be authorized by the Food and Drug Administration and indicated for colorectal cancer screening, processed in a CLIA-certified laboratory, and meet the requirements of any FDA-required post-approval study to keep coverage. Patients must be given information about the test's performance and the importance of a follow-on colonoscopy if the result is positive.

Tests must also meet one of two performance criteria based on FDA labeling: sensitivity of at least 90% with specificity of at least 87%, or sensitivity of at least 79% with specificity of at least 90%, in detecting colorectal cancer compared with colonoscopy. CMS wrote that "we provide a direct pathway for coverage of appropriate mt-sDNA, mt-sRNA, and BBB CRC screening tests when the criteria are met," referring to multitarget stool DNA, multitarget stool RNA and blood-based biomarker tests.

In its evidence review, CMS cited the pivotal CRC-PREVENT study of ColoSense, published by Barnell and colleagues in 2023, which reported 94.4% sensitivity for colorectal cancer and 87.9% specificity for no lesions on colonoscopy. The agency noted that all studies of the commercially available tests it reviewed were supported by the companies that developed them, and that FDA has required a post-approval study for ColoSense to add at least 23 more cancer cases. Some commenters had asked CMS to delay the final memo to convene an advisory committee; CMS said its process does not provide for one at that stage.

Company response

Geneoscopy announced the coverage in a release distributed by Business Wire, read via BioSpace, saying the decision gives Medicare's approximately 65 million eligible beneficiaries access to the test. "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.

The company said that in average-risk patients ColoSense is 93% sensitive for colorectal cancer and 45% sensitive for advanced adenomas, figures it attributes to its clinician brochure. ColoSense received FDA premarket approval (P230001) on May 3, 2024, according to the CMS memo, and is run at Geneoscopy's single CLIA-certified laboratory, the company said.