Labcorp makes RNA-based colorectal cancer home test available nationwide

Labcorp (NYSE: LH) announced the nationwide availability of ColoSense®, an RNA-based at-home colorectal cancer screening test developed by Geneoscopy, through a commercial collaboration between the two companies.

ColoSense is the only RNA-based at-home colorectal cancer screening test approved by the U.S. Food and Drug Administration. The test detects biomarkers associated with colorectal cancer and advanced adenomas. It received FDA Breakthrough Device Designation and is included in screening guidelines from the American Cancer Society and the National Comprehensive Cancer Network.

The test is now covered for eligible Medicare and Medicare Advantage beneficiaries following a Centers for Medicare & Medicaid Services update to the National Coverage Determination in June. Additional commercial coverage is also available.

ColoSense is available through healthcare providers for adults aged 45 to 85 at average risk. The company reports the test demonstrated 93% sensitivity for colorectal cancer in average-risk individuals and 100% sensitivity for stage I colorectal cancer, based on a sample of 12 patients.

Once ordered, a collection kit is delivered to the patient's home. The kit is designed to minimize sample handling by eliminating the need to separate or mix the stool sample. Geneoscopy provides patient navigation support to help individuals interpret results and pursue follow-up care, including colonoscopy after a positive result.

"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.

The test is not intended for individuals with a personal history of colorectal cancer or certain high-risk conditions, and does not replace diagnostic colonoscopy. According to the press release, Labcorp's own research found that 41% of at-home screening test users were uncomfortable preparing samples, and 34% described the process as messy.

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