Labcorp partners with Geneoscopy for nationwide commercial rollout of ColoSense

USA—Labcorp has introduced ColoSense, the inaugural FDA-approved at-home RNA-based test for colorectal cancer in the US, significantly broadening non-invasive screening choices for adults at average risk.

The nationwide rollout follows a recent update to the US Centers for Medicare & Medicaid Services’ (CMS) National Coverage Determination, making the test available to eligible Medicare and Medicare Advantage beneficiaries, while additional commercial insurance coverage is also in place.

Expanding access to at-home screening

Developed by Geneoscopy and offered commercially through Labcorp, ColoSense is intended for adults aged 45 to 85 years who are considered to have an average risk of colorectal cancer.

However, it is not recommended for individuals with a personal history of colorectal cancer, inflammatory bowel disease, inherited colorectal cancer syndromes, or other high-risk conditions.

The new screening option arrives as healthcare providers continue to encourage more people to undergo routine colorectal cancer screening.

Although early detection greatly improves treatment outcomes, nearly four in ten eligible adults in the United States remain behind on recommended screening schedules, according to Labcorp.

RNA technology aims to simplify testing

Unlike traditional stool-based screening tests, ColoSense uses RNA technology to identify biomarkers associated with both colorectal cancer and advanced adenomas—precancerous growths that can develop into cancer if left untreated.

The FDA previously granted the test Breakthrough Device Designation, recognising its potential to improve the detection of life-threatening diseases.

Labcorp says the test was designed to overcome common barriers that discourage people from completing at-home screening.

Internal research found that 41% of users felt uncomfortable preparing stool samples, while 34% described the collection process as messy.

To address these concerns, the ColoSense kit features a simplified collection system that minimises direct sample handling and removes the need to separate or mix the specimen before returning it for laboratory analysis.

Once a healthcare provider orders the test, the collection kit is delivered directly to the patient’s home.

After the sample is collected, it is mailed back to Labcorp for analysis.

Geneoscopy also provides patient navigation services to help users understand their results and, when necessary, arrange appropriate follow-up care, including diagnostic colonoscopy after a positive screening result.

Strong clinical performance and guideline recognition

According to clinical data released by Labcorp, ColoSense demonstrated 93% sensitivity in detecting colorectal cancer among average-risk individuals.

The test also achieved 100% sensitivity in identifying stage I colorectal cancer during clinical evaluation, highlighting its ability to detect cancer at one of its earliest and most treatable stages.

The screening test is recognised in the colorectal cancer screening recommendations of both the American Cancer Society and the National Comprehensive Cancer Network, further supporting its use as an evidence-based screening option for eligible adults.

However, Labcorp emphasises that ColoSense is strictly a screening tool and does not replace diagnostic colonoscopy, particularly for individuals who receive positive test results or present with symptoms suggestive of colorectal cancer.

Labcorp Chief Medical and Scientific Officer Dr. Brian Caveney said the company aims to increase colorectal cancer screening rates by offering at-home options that patients are more willing to complete.

He noted that the nationwide availability of ColoSense broadens access to an FDA-approved screening test that combines advanced molecular science with a cleaner, more convenient collection experience.

Meanwhile, Geneoscopy Chief Commercial Officer Matt Sargent said the partnership with Labcorp will help bring years of scientific innovation into routine clinical practice, enabling more patients to benefit from earlier detection of colorectal cancer.