Geneoscopy announced that CMS has granted Medicare coverage for ColoSense®, the first FDA-approved stool RNA test for colorectal cancer screening, expanding access to approximately 65 million Medicare beneficiaries.
The company says ColoSense demonstrated 93% sensitivity for colorectal cancer, 45% sensitivity for advanced adenomas, and 100% sensitivity for Stage I colorectal cancer in its pivotal study. CMS coverage follows recent ACS guideline updates that include stool RNA testing as a preferred screening option, further validating RNA-based approaches as an emerging category in colorectal cancer screening.
The decision also reflects growing momentum behind noninvasive screening technologies designed to improve participation rates, particularly among older adults who may be reluctant to undergo colonoscopy or traditional stool-based testing. However, as with all non-colonoscopy screening methods, positive results still require follow-up colonoscopy to complete the screening process.