Labcorp Announces Nationwide Availability of ColoSense®, the First FDA-Approved RNA-Based At-Home Colorectal Cancer Screening Test
- First FDA-approved, at-home screening test that uses RNA technology to detect biomarkers associated with colorectal cancer and advanced adenomas
- Designed to reduce common barriers to at-home screening with a cleaner, simplified collection experience that minimizes sample handling
- Meets screening guidelines from the American Cancer Society (ACS) and National Comprehensive Cancer Network (NCCN)
BURLINGTON, N.C. and ST. LOUIS, June 22, 2026 /PRNewswire/ -- Labcorp (NYSE:LH), a global leader of innovative and comprehensive laboratory services, today announced the nationwide availability of ColoSense®, the only RNA-based at-home test for colorectal cancer (CRC) screening approved by the U.S. Food and Drug Administration (FDA). Offered through a commercial collaboration with test developer Geneoscopy, ColoSense expands Labcorp's comprehensive portfolio of colorectal cancer screening solutions. The test is now covered for eligible Medicare and Medicare Advantage beneficiariesi following the Centers for Medicare & Medicaid Services (CMS) update to the National Coverage Determination (NCD) in June, with additional commercial coverage also available.
Reducing Barriers to At-Home Screening
Colorectal cancer is highly preventable when detected early, yet approximately 4 in 10 eligible adults are not up to date with recommended screenings. While at-home tests offer convenience, the collection process can be a significant barrier to completion. According to Labcorp research, among users of at-home screening tests, 41% were uncomfortable preparing the sample, and 34% said the process felt messy. ColoSense is designed to reduce common barriers to at-home screening with a cleaner, simplified collection experience that minimizes sample handling.
"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. "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."
Breakthrough Innovation Recognized by the FDA and Leading Cancer Authorities
ColoSense uses RNA-based technology to detect biomarkers associated with both colorectal cancer and advanced adenomas, precancerous changes that may be an early indication of disease. ColoSense received Breakthrough Device Designation from the FDA, which is reserved for medical devices that offer the potential for more effective diagnosis or treatment of life-threatening conditions. ColoSense aligns with stool-based RNA screening approaches recognized in the American Cancer Society (ACS) colorectal cancer screening guidelines and is included as a recommended screening option in the National Comprehensive Cancer Network (NCCN) guidelines.
"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. "We're proud to partner with Labcorp to help bring this test into routine care nationwide and ensure more patients can benefit from earlier detection."
ColoSense is available through healthcare providers for adults aged 45 to 85 at average risk and is not for individuals with a history of colorectal cancer or certain high-risk conditions. ColoSense has demonstrated strong clinical performance, with 93% sensitivity for colorectal cancer in average-risk individuals, and achieved 100% sensitivityii for stage I colorectal cancer, detecting disease at its most treatable stage.
Once ordered, the collection kit is delivered directly to the consumer's home for collection and return, featuring a simplified design that eliminates the need to separate or mix the stool sample. Geneoscopy offers patient navigation support to help individuals understand their results and follow recommended next steps, including colonoscopy after a positive result. ColoSense is a screening test and does not replace diagnostic colonoscopy.
The introduction of ColoSense further expands Labcorp's portfolio of colorectal cancer screening options, providing patients and providers with greater choice and flexibility. To learn more, visit https://www.labcorp.com/treatment-areas/colorectal-cancer/crc-screening/colosense.
About Labcorp
Labcorp (NYSE:LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 71,000 employees serve clients in approximately 100 countries, provided support for more than 85% of the new drugs and therapeutic products approved by the FDA in 2025 and performed more than 750 million tests for patients around the world. Learn more at www.labcorp.com.
About Geneoscopy, Inc.
Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy's mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other GI disease areas. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements with respect to the expected utility and benefits, and availability from Labcorp, of the ColoSense screening test for colorectal cancer.
Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the company's control. These factors, in some cases, have affected and in the future (together with other factors) could affect the company's ability to implement the company's business strategy, and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of the forward-looking statements.
The company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the company's most recent Annual Report on Form 10-K under the heading RISK FACTORS and in the company's other filings with the SEC. The information in this press release should be read in conjunction with a review of the company's filings with the SEC including the information in the company's most recent Annual Report on Form 10-K under the heading "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS."
iPatient Criteria: Age 45 to 85 years; asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test (gFOBT) or fecal immunochemical test (FIT)); and at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn's Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).
ii12/12 patients (100%, 95% confidence interval, 74%-100%)
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SOURCE Labcorp