Labcorp has announced the nationwide availability of ColoSense®, the first FDA-approved RNA-based at-home test for colorectal cancer (CRC) screening in the US.
Developed in collaboration with Geneoscopy, the test expands Labcorp’s colorectal cancer screening portfolio and is now available for eligible adults through healthcare providers.
Coverage is available for qualifying Medicare and Medicare Advantage beneficiaries following a Centers for Medicare & Medicaid Services (CMS) update, with additional commercial coverage also emerging.
RNA-based detection at home
ColoSense uses RNA technology to detect biomarkers associated with colorectal cancer and advanced adenomas, which are precancerous lesions linked to early disease development. The test is intended for adults aged 45 to 85 at average risk and is not indicated for individuals with a personal history of colorectal cancer or certain high-risk conditions. It aligns with stool-based RNA screening approaches recognized in American Cancer Society (ACS) and National Comprehensive Cancer Network (NCCN) colorectal cancer screening guidelines.
The test also received FDA Breakthrough Device Designation, reserved for technologies with potential to improve diagnosis or treatment of serious conditions.
Addressing screening barriers
Despite strong evidence supporting early detection, approximately 4 in 10 eligible adults remain behind on recommended colorectal cancer screening. According to Labcorp, 41% of at-home screening users reported discomfort with sample preparation, while 34% described the process as messy—factors the company says ColoSense is designed to address through a simplified collection method that reduces handling steps.
“Labcorp is focused on improving colorectal cancer screening rates by offering at-home options consumers are more likely to complete,” said Dr. Brian Caveney, chief medical and scientific officer at Labcorp, in a press release. "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 performance and workflow
In clinical evaluation, ColoSense demonstrated 93% sensitivity for colorectal cancer detection in average-risk individuals, including 100% sensitivity for stage I disease. After provider ordering, the kit is shipped directly to the patient’s home, where users collect and return samples using a simplified process that eliminates stool mixing or separation steps.
Geneoscopy provides patient navigation support to guide individuals through results and follow-up care, including colonoscopy when indicated. The companies emphasize that ColoSense is a screening test and does not replace diagnostic colonoscopy.
“ColoSense reflects years of scientific innovation focused on improving how we screen for colorectal cancer at home,” said Matt Sargent, chief commercial officer at Geneoscopy.
With national availability, ColoSense adds to Labcorp’s colorectal cancer screening offerings, aiming to increase completion rates and support earlier detection through more accessible at-home testing options.
Note: This news summary was generated by AI based on a published press release, followed by a review from human editors.
