Geneoscopy said the U.S. Centers for Medicare and Medicaid Services expanded national coverage for colorectal cancer screening tests to include its ColoSense stool-based RNA assay. The update adds a framework for high-sensitivity RNA-based approaches, positioning Geneoscopy for broader access under Medicare as long as FDA approval is maintained. For average-risk patients, the company reported 93% sensitivity for colorectal cancer and 45% sensitivity for advanced adenomas, with 100% sensitivity for stage I cancer. The test also detects colorectal neoplasia-associated RNA markers and occult hemoglobin in stool, with a three-year interval referenced in NCCN and American Cancer Society guidance. Geneoscopy also pointed to a collaboration with Labcorp to expand availability through the lab’s nationwide network. The CMS change matters for manufacturers of next-generation screening tests because Medicare coverage often determines adoption at scale for in vitro diagnostics. The immediate industry impact is that RNA-based screening moves from “emerging option” to “reimbursed testing pathway” for Medicare beneficiaries, which may accelerate competition in molecular stool diagnostics and reduce barriers to reimbursement-driven scale-up.
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