Geneoscopy’s FDA-Approved At-Home RNA Colorectal Cancer Test
Geneoscopy has received FDA approval for ColoSense, a noninvasive, at-home RNA-based colorectal cancer screening test for adults aged 45 and older at average risk.
ColoSense: A Breakthrough in Colorectal Cancer Screening
ColoSense utilizes RNA biomarkers to detect colorectal cancer (CRC) and advanced adenomas (AA) with high sensitivity. In the pivotal CRC-PREVENT trial, ColoSense demonstrated 94% sensitivity for CRC detection and 46% sensitivity for AA. Notably, among participants aged 45-49, the test achieved 100% sensitivity for CRC and 44% for AA, addressing the rising incidence of early-age onset CRC.
Advantages of RNA-Based Screening
Traditional screening methods often rely on DNA biomarkers, but ColoSense’s RNA-based approach offers a dynamic view of disease activity, potentially enhancing diagnostic accuracy. This innovation positions ColoSense as a valuable tool in gastrointestinal diagnostics.
Funding and Commercialization Efforts
To support the commercialization of ColoSense, Geneoscopy secured $105 million in Series C funding. These funds will facilitate marketing efforts and broader accessibility of the test.
Challenges and Future Outlook
Despite its approval, ColoSense faces challenges, including securing Medicare coverage and integrating into existing screening guidelines. However, its approval marks a significant advancement in noninvasive colorectal cancer screening, offering a convenient and accurate option for early detection.
