ColoSense: New Colorectal Cancer Screening Test Covered by Medicare

Geneoscopy, Inc. has announced that the Centers for Medicare & Medicaid Services (CMS) will now cover ColoSense, a stool-based colorectal cancer screening test. This decision provides approximately 65 million Medicare beneficiaries with access to ColoSense, the first FDA-approved stool-RNA test designed for colorectal cancer detection. The screening approach eliminates traditional barriers by requiring minimal sample handling, enhancing user convenience without compromising diagnostic performance.

The National Coverage Determination (NCD) for colorectal cancer screening has been updated to accommodate innovations such as ColoSense. This adjustment reflects CMS's commitment to supporting advanced screening technologies, ensuring beneficiaries can access innovative and preventive healthcare options.

Andrew Barnell, CEO of Geneoscopy, stated, "The updated NCD framework emphasizes early cancer detection through preventive screening." ColoSense offers 93% sensitivity for detecting colorectal cancer and 45% sensitivity for identifying advanced adenomas among average-risk patients, demonstrating consistent efficacy across various age groups. Additionally, the test exhibited 100% sensitivity at stage I cancer, significantly improving treatment outcomes.

Aligned with guidelines from the National Comprehensive Cancer Network (NCCN) and the American Cancer Society (ACS), the CMS decision supports a three-year screening interval for adults aged 45-85. Despite progress in reducing colorectal cancer incidence among Medicare beneficiaries, a significant number of diagnoses occur in individuals aged 65 and above. Thus, the adoption of ColoSense aims to bridge critical gaps in screening accessibility, making it a viable option for this demographic.

A partnership with Labcorp will further facilitate the distribution and implementation of ColoSense, leveraging Labcorp's extensive network to reach a wider audience of both providers and patients. This collaboration enhances the patient journey, from order and sample collection to post-result guidance for those testing positive.

ColoSense stands out as the only stool-based RNA test approved by the FDA for colorectal cancer screening, targeting adults over 45 at average risk. It detects RNA markers and occult hemoglobin in the stool, serving as a preliminary step prior to diagnostic or surveillance colonoscopies in high-risk individuals. Should ColoSense yield a positive result, follow-up with a colonoscopy is recommended.

Developed by Geneoscopy, ColoSense supports the company's mission to advance gastrointestinal health diagnostics. Their stool-RNA biomarker platform underpins ongoing collaborations with leading universities and biopharmaceutical firms to refine diagnostic applications across patient treatment and therapy monitoring landscapes.