Labcorp has announced the availability of ColoSense, its ribonucleic acid (RNA)-based at-home screening test for colorectal cancer that has been approved by the US Food and Drug Administration (FDA).
Developed by Geneoscopy, the test is being provided commercially through Labcorp following an update to the US Centers for Medicare & Medicaid Services’ (CMS) National Coverage Determination this month.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
ColoSense is available for eligible Medicare and Medicare Advantage beneficiaries, with further commercial coverage options also in place.
It is designed for adults aged 45 to 85 years who are considered at average risk for colorectal cancer. The test is not intended for people with a history of colorectal cancer or certain high-risk medical conditions.
Using RNA-based methods, ColoSense detects biomarkers linked to both colorectal cancer and advanced adenomas, which are early, precancerous changes.
The FDA had previously awarded breakthrough device designation, indicating potential for improved diagnosis of life-threatening conditions.
The company stated that conventional at-home tests can be challenging for patients to complete, with internal research indicating that 41% of users felt uncomfortable preparing the sample and 34% found the process messy.
ColoSense aims to address these issues by offering a simplified sample collection kit that minimises direct handling and eliminates the need to separate or mix the stool sample.
Once a healthcare provider orders the test, the patient receives the kit at home for sample collection and return.
Labcorp chief medical and scientific officer Dr Brian Caveney said: “Labcorp is focused on improving colorectal cancer screening rates by offering at-home options consumers are more likely to complete.
“With ColoSense now available nationwide, we’re expanding access to an FDA-approved screening option that delivers advanced science and a more streamlined, easier-to-use collection experience.”
Clinical data referenced by Labcorp indicates ColoSense demonstrated 93% sensitivity for detecting colorectal cancer in average-risk individuals and 100% sensitivity for stage I colorectal cancer.
The test is included in the screening guidelines of both the American Cancer Society and the National Comprehensive Cancer Network.
ColoSense is intended as a screening tool and does not replace diagnostic colonoscopy.
