Geneoscopy’s latest FDA approval marks a meaningful innovation in at-home colorectal cancer (CRC) screening, simplifying one of the most uncomfortable aspects of stool-based testing. The updated stool collection kit for ColoSense®, Geneoscopy’s RNA-based CRC screening test, eliminates the need for sample scraping and multiple containers, making the process more user-friendly. By streamlining collection without compromising clinical performance, this improvement is poised to overcome a key barrier to patient adherence – particularly for those hesitant about traditional stool-based methods. In doing so, the company addresses a critical access challenge in CRC screening among the more than 44 million average-risk individuals aged 45 to 75 who remain unscreened.
ColoSense stands out as the only FDA-approved RNA-based test for CRC, offering high sensitivity for both cancer and advanced adenomas. The test’s ability to detect early-stage colorectal cancer, including in individuals aged 45-49-a population seeing rising incidence rates-is particularly impactful. Its inclusion in NCCN guidelines and its distribution partnership with Labcorp position it as a powerful tool in national CRC prevention efforts. The improved usability of the test further strengthens its potential as a first-line, non-invasive option that aligns with patient preferences for at-home, high-sensitivity diagnostics.