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— 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."
i Patient 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).
ii 12/12 patients (100%, 95% confidence interval, 74%–100%)
CMS Grants Medicare Coverage for ColoSense®, Expanding Access to Simplified Noninvasive Colorectal Cancer Screening
Medicare coverage will provide approximately 65 million eligible Medicare beneficiaries access to the first FDA-approved colon cancer screening stool-RNA test.
ST. LOUIS, Mo.—June 08, 2026— Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved coverage for FDA-approved ColoSense®, a stool-based colorectal (CRC) screening test, within the National Coverage Determination (NCD) for colorectal cancer screening tests.
Coverage for ColoSense provides Medicare's approximately 65 million eligible beneficiaries with access to the first FDA-approved, high-sensitivity stool-RNA test that addresses one of the most commonly cited barriers to stool-based screening: the need to handle the sample during collection.1 ColoSense requires only three simple steps, with no stool scraping required, eliminating the need for patients to manipulate the stool sample, while maintaining clinical performance for detection of colorectal cancer and advanced adenomas.
Forward-Thinking Coverage Framework Supports Innovation
The updated National Coverage Determination (NCD) for CRC screening also establishes a framework that supports future innovations, including new or improved RNA-based assays.
"We applaud CMS for revising the NCD for CRC screening tests in a way that is forward-thinking and allows for new innovation in this area of testing," said Geneoscopy CEO, Andrew Barnell. "Restructuring the CRC Screening NCD to include high-sensitivity tests like ColoSense demonstrates the importance that CMS places on earlier detection of colorectal cancer through preventive screening. This new framework ensures that Medicare beneficiaries will have timely access to innovative screening technologies that receive FDA approval."
In average-risk patients, ColoSense is 93% sensitive for CRC and 45% sensitive for advanced adenomas, with consistent performance across age groups.1 Notably, ColoSense showed 100% sensitivity for stage I cancer,* detecting CRC at its most treatable stage when the five-year survival rate is approximately 90%.1,2
CMS coverage aligns with current NCCN and ACS guidelines, which recommend ColoSense as a preferred screening option with a three-year testing interval for average-risk adults aged 45 to 85.
Addressing Critical Gaps in Colorectal Cancer Screening for Medicare Patients
Despite improvements in colorectal cancer incidence within the Medicare population, more than half of all colorectal cancer diagnoses still occur in patients 65 and older.3
CMS coverage for ColoSense provides Medicare beneficiaries with an additional, guideline-endorsed screening option that removes common barriers to test completion. "With such a high percentage of new cancer diagnoses still occurring in the Medicare population, it was critical for CMS to expand coverage to include new, non-invasive tests," added Barnell. "The addition of a new, high-sensitivity stool test like ColoSense, with a simplified specimen collection methodology that eliminates the need for patients to manipulate the stool sample, can make at-home screening easier for the 65 and older population. A simple testing process is important for Medicare beneficiaries, who may demonstrate limited dexterity or lower health literacy."4
A strategic collaboration with Labcorp will further expand access to ColoSense, enabling broader provider and patient adoption through Labcorp's nationwide network. The ColoSense experience includes a structured patient support process that engages ColoSense recipients throughout the CRC screening continuum: from the point of order and sample collection, through navigation support to colonoscopy for patients with positive/abnormal results. Providers can customize the level and type of support that their patients receive.
*12/12 patients, 95% CI 74%–100%
About ColoSense
ColoSense is the first and only FDA-approved stool-based RNA test for colorectal cancer screening. The test is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool.
ColoSense is indicated as a screening test for adults aged 45 years or older who are at average risk for developing CRC and is included in NCCN and ACS guidelines with a recommended three-year testing interval.1 ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
A positive ColoSense result may indicate the presence of colorectal cancer, advanced adenomas, or serrated precancerous lesions and should be followed by a colonoscopy. ColoSense is a single-site test performed at Geneoscopy's CLIA-certified laboratory.
Results from Geneoscopy's pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA).5 For more information, visit www.colosense.com.
About Geneoscopy, Inc.
Geneoscopy is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA biomarker platform, Geneoscopy's mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company's FDA-approved ColoSense test uses an RNA-based platform to screen for colorectal cancer and advanced adenomas in average-risk individuals 45 years of age or older. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is developing diagnostic tests for treatment selection and therapy monitoring. For more information, visit www.geneoscopy.com.
Media Contact
media@geneoscopy.com
Investor Contact
Amit Bhalla, Chief Financial Officer
amit.bhalla@geneoscopy.com
References
1. ColoSense Clinician Brochure, St. Louis, MO, Geneoscopy, Inc.
2. American Cancer Society. Colorectal Cancer Facts & Figures 2023–2025. Atlanta: American Cancer Society; 2023.
3. Siegel RL, Wagle NS, Jemal A. Leading Cancer Deaths in People Younger Than 50 Years. JAMA. 2026;335(3):e2525467. doi:10.1001/jama.2025.25467
4. Liu PH, Nair RG, Skinner CS, et al. Unsatisfactory fecal immunochemical tests for colorectal cancer screening: prevalence, reasons, and subsequent testing. Cancer Epidemiol Biomarkers Prev. 2024;33(2):215-223. doi:10.1158/1055-9965.EPI-23-0507
5. Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023;330(18):1760-1768. doi:10.1001/jama.2023.22231
Geneoscopy's ColoSense® Test Included as a Preferred Option in the American Cancer Society Colorectal Cancer Screening Guidelines Update
Guideline inclusion recognizes ColoSense as an evidence-based, preferred solution for colorectal cancer screening in average-risk individuals aged 45+.
ST. LOUIS, Mo.—[May 27, 2026]— Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for gastrointestinal health, today announced that the American Cancer Society (ACS) has updated its colorectal cancer (CRC) screening guidelines to include ColoSense®, Geneoscopy's FDA-approved at-home stool test. This update marks the first time a noninvasive RNA-based test has been included in ACS screening guidelines for detecting colorectal cancer and advanced adenomas in average-risk adults aged 45 or older. ColoSense is also included in the National Comprehensive Cancer Network® (NCCN®) colorectal cancer screening guidelines.
The ACS guidelines are considered a definitive gold standard in the field of oncology and public health. Guidelines are developed by top oncologists, epidemiologists, primary care clinicians, and biostatisticians who commission systematic, independent reviews of the highest-quality evidence to assess real-world impact on cancer mortality. The 2026 Colorectal Screening Guidelines update adds ColoSense (mt-sRNA) as a new preferred test to the choice of stool‐based testing. The addition of the mt‐sRNA is supported by performance data and modeling studies indicating potential to reduce CRC incidence and mortality when used with appropriate follow‐up.1
"We commend the American Cancer Society for embracing testing methods that reflect the rapid pace of innovation in cancer screening," said Andrew Barnell, CEO and co-founder of Geneoscopy. "Expanding the range of recommended screening options will improve screening rates. ColoSense combines clinical accuracy with a patient-friendly experience and can help identify patients most at risk of cancer progression."
The ACS guideline inclusion represents a significant validation of RNA technology in colorectal cancer screening. In the pivotal CRC-PREVENT trial, ColoSense demonstrated high sensitivity for colorectal cancer (93%) and advanced adenomas (45%), including 100% sensitivity for stage I cancer detection,2* in average-risk individuals.3 ColoSense offers a streamlined stool collection process that does not require patients to separate their sample into multiple containers. This seamless, scrape-free experience puts patient comfort first and reduces barriers to at-home screening,4 while maintaining clinical performance.
"This guideline update reinforces the importance of making screening both reliable and approachable for all patients," said Erica Barnell, MD, PhD, co-founder and Chief Science and Medical Officer at Geneoscopy. "By broadening access to accurate, at-home options that remove unnecessary burdens from patients, we can help more people take that critical first step toward prevention."
ColoSense was approved by the U.S. Food and Drug Administration (FDA) in May 2024. On March 10, 2026, the Centers for Medicare & Medicaid Services (CMS) proposed changes to the National Coverage Determination that would cover ColoSense. CMS is expected to issue a final coverage memorandum on June 8, 2026. If covered under the revised NCD, ColoSense would be accessible for the 65 million Medicare beneficiaries enrolled in the program. ColoSense is currently available to providers in all 50 states through Geneoscopy's online direct order portal. A strategic collaboration with Labcorp will further expand access to ColoSense in the coming months, enabling broader provider and patient adoption through Labcorp's nationwide network.
Colorectal cancer is the second leading cause of cancer-related death in the United States, and the leading cause of cancer death among adults under 50, yet 41% of adults aged 45 and older remain unscreened.5,6 When detected early, before it has spread, the five-year relative survival rate is approximately 90%. The rate of colorectal cancer is increasing among younger adults, including those between 45 and 50 years of age, making screening adherence in this population particularly critical.7
*12/12 patients (100%, 95% confidence interval, 74%–100%)
About ColoSense
ColoSense is an FDA-approved screening test for the qualitative detection of colorectal neoplasia-associated RNA markers and occult hemoglobin in human stool. Indicated for adults aged 45 years or older at average risk for colorectal cancer, ColoSense is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals. A positive result may indicate colorectal cancer, advanced adenomas, or serrated precancerous lesions and should be followed by colonoscopy. Results from Geneoscopy's pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA).6 For more information, visit www.colosense.com.
About Geneoscopy, Inc.
Geneoscopy is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA biomarker platform, Geneoscopy's mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company's FDA-approved ColoSense test uses an RNA-based platform to screen for colorectal cancer and advanced adenomas in average-risk individuals age 45 or older. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is developing diagnostic tests for treatment selection and therapy monitoring. For more information, visit www.geneoscopy.com.
Media Contact
media@geneoscopy.com
Investor Contact
amit.bhalla@geneoscopy.com
References
1. Wolf AMD, Hoffman RM, Walter LC, et al. Colorectal cancer screening: an update to the American Cancer Society guideline, 2026. CA Cancer J Clin. 2026; e70083. doi:10.3322/caac.70083
2. Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023;330(18):1760-1768. doi:10.1001/jama.2023.22231
3. U.S. Food and Drug Administration. (2024). Summary of Safety and Effectiveness Data (SSED): ColoSense (PMA P230001). Stage 1 CRC (100%, 95%CI, 74%-100%) https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230001B.pdf
4. Luque, J. S., Wallace, K., Blankenship, B. F., Roos, L. G., Berger, F. G., LaPelle, N. R., & Melvin, C. L. (2018). Formative research on knowledge and preferences for stool-based tests compared to colonoscopy: What patients and providers think. Journal of Community Health, 43(6), 1085–1092. https://doi.org/10.1007/s10900-018-0525-x
5. Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45.
6. Siegel RL, Wagle NS, Jemal A. Leading Cancer Deaths in People Younger Than 50 Years. JAMA. 2026;335(3):e2525467. doi:10.1001/jama.2025.25467
7. Siegel, R. L., Wagle, N. S., Cercek, A., Smith, R. A., & Jemal, A. (2023). Colorectal cancer statistics, 2023. CA: A Cancer Journal for Clinicians, 73(3), 233–254. https://doi.org/10.3322/caac.21772
Geneoscopy Wins Second Patent Trial and Appeal Board Decision, Invalidating All Challenged Claims of Exact Sciences’ ’746 Patent
Decision removes last patent hurdle as Geneoscopy advances ColoSense®, its RNA-based noninvasive colorectal cancer screening test
ST. LOUIS, Mo. – February 6, 2026 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a Final Written Decision following inter partes review (IPR), finding all 10 challenged claims of Exact Sciences’ U.S. Patent No. 11,970,746 (the ’746 patent) unpatentable. This decision follows the PTAB’s July 2025 Final Written Decision invalidating all 20 claims of Exact Sciences’ U.S. Patent No. 11,634,781 (the ‘781 patent). As a result, all patent claims asserted by Exact Sciences against the company in the parties’ ongoing litigation have now been invalidated by the PTAB.
The PTAB’s ruling concluded that all claims of the ’746 patent challenged by the company before the PTAB are unpatentable in view of prior art describing stool sample collection and processing. The PTAB’s decision to invalidate all challenged claims of the ‘746 patent, following its final decision invalidating all claims of the ‘781 patent, further confirms Geneoscopy’s long-held position and clears the path for the continued commercialization of ColoSense.
“The PTAB’s final decisions on these two patents validate what we have believed all along—that the claims in both the ’781 patent and the ‘746 patent being asserted by Exact Sciences against the company should never have been issued,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This outcome underscores that invalid patents cannot be used to limit patient access to life-saving colorectal cancer screening options like ColoSense. These final decisions are also a critical step toward protecting patient choice and advancing high-quality, innovative, noninvasive screening solutions.”
Geneoscopy filed the IPR petition after Exact Sciences initiated a patent infringement suit against the company in the U.S. District Court for the District of Delaware. The PTAB’s ruling on the ‘746 patent removes all of Exact Sciences’ patent challenges against ColoSense in that case, as all patent claims asserted against the company in the litigation have now been invalidated by the PTAB.
As part of the litigation, Geneoscopy has filed counterclaims against Exact Sciences alleging breach of contract, misappropriation of trade secrets, false advertising, and unfair competition (Exact Sciences Corporation v. Geneoscopy, Inc., C.A. No. 23-1319-MN (D. Del.)).
About ColoSense
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.
A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.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. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Investor Contact:
Amit Bhalla
Chief Financial Officer
314-887-7777
Amit.Bhalla@geneoscopy.com
Geneoscopy’s Scrape-Free Collection Method for Colorectal Cancer Screening Validated by New Data and Peer-Reviewed Publication
ST. LOUIS, Mo.—October 22, 2025 — Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced new peer-reviewed data in Practical Laboratory Medicine validating the analytical reliability of the scrape-free collection method used in its ColoSense® colorectal cancer (CRC) screening test. The method, which eliminates patient handling of stool and standardizes testing in the laboratory, will be highlighted at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting on Monday, Oct. 27, 2025.
The recently published study, “Analytical validation of a scrape-free multitarget stool RNA test for colorectal cancer screening,” evaluated the fecal immunochemical test (FIT) component used with Geneoscopy’s FDA-approved ColoSense screening test. Across more than 1,300 replicates, ColoSense demonstrated high reliability and reproducibility under a range of simulated and real-world scenarios, including variable stool volumes, common dietary interferences, freeze-thaw cycles, and in-transit times up to 120 hours. A prospective, clinical equivalency analysis showed 94% agreement between results from the in-lab FIT and those from traditional at-home FIT.1 Additionally, in retrospective testing, the in-lab FIT achieved high sensitivity for colorectal cancer and advanced adenomas, consistent with established performance benchmarks.1
“Accurate, patient-friendly collection methods are essential to improving participation in colorectal cancer screening,” said Erica Barnell, MD, PhD, Chief Science and Medical Officer at Geneoscopy and lead author of the study. “Our continued research reinforces that simplifying the collection process can enhance accuracy while reducing barriers that often limit screening completion. We look forward to sharing our latest developments at ACG.”
ColoSense utilizes an FDA-approved, no-touch, single-sample collection process that allows patients to send a stabilized stool sample directly to the laboratory, where trained technicians perform all analyses under controlled conditions. This standardized approach reduces variability, ensures consistent results, and eliminates issues associated with at-home FIT collection.
Geneoscopy will be available to discuss ColoSense and its clinical research at Booth #565 during ACG 2025. The company’s poster, P2612 (Category: Colon Cancer), will be presented in the Exhibit Hall on Oct. 27, 2025, from 10:30 a.m. to 4:00 p.m. PDT. Additional information is available through the ACG 2025 Poster Program.
About ColoSense
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.
A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA). For more information, visit www.colosense.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. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Contacts:
Media
Andrea Sampson, Sampson PR Group
asampson@sampsonprgroup.com
Investor Relations
Amit Bhalla, CFO, Geneoscopy
amit.bhalla@geneoscopy.com
References
- Barnell EK, Kruse K, Wurtzler EM, Scott MC, Barnell AR, Duncavage EJ. Analytical validation of a scrape-free multitarget stool RNA test for colorectal cancer screening. Practical Laboratory Medicine. 2025;47:e00502. https://doi.org/10.1016/j.plabm.2025.e00502
Legal Win for Geneoscopy as Exact Sciences Withdraws Preliminary Injunction Against ColoSense®
ST. LOUIS, Mo.—August 22, 2025 — Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that Exact Sciences has withdrawn its motion for a preliminary injunction regarding U.S. Patent No. 11,634,781 (“the ‘781 patent”) and U.S. Patent No. 11,970,746 (“the ‘746 patent”).
Exact Sciences’ preliminary injunction motion, filed in July 2024, sought to prevent Geneoscopy’s commercialization of its stool-based colorectal cancer screening test, ColoSense. The withdrawal is consistent with Geneoscopy’s firmly held view that the preliminary injunction motion was baseless. This development allows Geneoscopy to continue expanding access to ColoSense for eligible patients and providers without restriction.
“By taking this step, Exact Sciences confirms what we have said all along—ColoSense is grounded in innovation, not infringement,” said Andrew Barnell, co-founder and CEO of Geneoscopy. “Competition fosters scientific progress and improves patient care. We are excited to continue moving ColoSense forward, bringing a new and patient-friendly cancer screening option to market that enhances early detection and saves lives.”
Withdrawal of the preliminary injunction motion follows other recent favorable developments for Geneoscopy. In July, the U.S. Patent Trial and Appeal Board (PTAB) found all 20 challenged claims of the ’781 patent unpatentable. This was preceded by PTAB’s decision to institute review of a second patent asserted by Exact Sciences (the ‘746) on substantially the same grounds cited by the PTAB in invalidating the ‘781 patent.
About ColoSense
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.
A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA). For more information, visit www.colosense.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. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Contacts:
Media
Andrea Sampson, Sampson PR Group
asampson@sampsonprgroup.com
Investor Relations
Amit Bhalla, CFO, Geneoscopy
amit.bhalla@geneoscopy.com
Geneoscopy’s New FDA-Approved Stool Collection Method Simplifies At-Home Colorectal Cancer Screening
Pairing diagnostic innovation with improved patient experience, ColoSense aims to streamline the screening process and increase compliance
ST. LOUIS, Mo.—July 24, 2025 — Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, received FDA approval to streamline the stool collection process for ColoSense®, its RNA-based colorectal cancer (CRC) screening test. The newly approved collection kit no longer requires patients to separate their sample into multiple containers. This improves ease of use and reduces barriers to at-home screening,¹ while maintaining clinical performance.
“We’ve taken a critical step toward improving the at-home colorectal cancer screening experience by removing one of the most burdensome aspects for patients—the scraping of stool,” said Dr. Erica Barnell, Chief Medical & Science Officer of Geneoscopy. “The new collection kit simplifies the process for collecting a patient’s stool sample. By eliminating the most confusing and undesirable step, we believe ColoSense will drive higher adherence and better outcomes.”
ColoSense is indicated for individuals aged 45 and older who are at average risk for CRC. It uses advanced RNA technology to detect biomarkers associated with CRC and advanced adenomas (AA)—precancerous growths that can develop into cancer if left untreated. As the only FDA-approved RNA-based test for CRC screening, ColoSense demonstrated 93% sensitivity for CRC and 45% sensitivity for AA in average-risk individuals. Among average-risk individuals aged 45 to 49, where CRC incidence is on the rise, the test demonstrated 100% sensitivity for CRC and 44% sensitivity for AA*.
Despite the availability of multiple screening options, an estimated 44 million people aged 45-75 remain unscreened for CRC.² To help address a common barrier to stool-based screening, the updated ColoSense collection kit removes the need to scrape the sample. This improvement is expected to increase patient compliance, lower the rate of collection errors, and reduce the frequency of invalid samples. This ease of use can translate into fewer missed screenings and a greater overall impact on population health.
“To exceed 80% compliance for colorectal cancer screening, the patient experience for stool-based screening must be improved,” said Andrew Barnell, Chief Executive Officer of Geneoscopy. “The new ColoSense test does that, offering patients everything they like about at-home, high-sensitivity screening, but now, with an easier collection process.”
ColoSense is included in National Comprehensive Cancer Network (NCCN) guidelines, based on an evaluation of the strength of its clinical evidence and the robust science behind the technology. The test will be available through Geneoscopy’s strategic collaboration with Labcorp, expanding access for providers and patients across the United States. ColoSense represents a significant advancement in noninvasive stool testing options, reinforcing the importance of accessible tools that help reach individuals who are less likely to undergo colonoscopy.
About ColoSense
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.
A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA). For more information, visit www.colosense.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. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
References
- Luque JS, Wallace K, Blankenship BF, et al. Formative Research on Knowledge and Preferences for Stool-based Tests compared to Colonoscopy: What Patients and Providers Think. J Community Health. 2018;43(6):1085-1092. doi:10.1007/s10900-018-0525-x
- Hyams T, Mueller N, Curbow B, et al. Screening for colorectal cancer in people ages 45–49: research gaps, challenges and future directions for research and practice, Transl. Behav. Med, Volume 12, Issue 2, Feb 2022, Pages 198–202. https://doi.org/10.1093/tbm/ibab079
*ColoSense identified 5/5 colorectal cancers and 37/84 advanced adenomas
Geneoscopy to Participate in Upcoming Investor Conferences
ST. LOUIS, Mo.—July 17, 2025 — Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health,today announced that members of its management team will be participating in the following investor conferences:
- Morgan Stanley Global Healthcare Conference in New York City
September 8, 2025 – September 10, 2025 - Bank of America Healthcare Trailblazers Private Company Conference in Boston
September 17, 2025 – September 18, 2025 - UBS Global Healthcare Conference in Palm Beach Gardens
November 9, 2025 – November 12, 2025 - Stifel Healthcare Conference in New York City
November 11, 2025 – November 13, 2025
One-on-one meetings with company management are available during the conferences upon request.
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. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Investor Relations Contact
Amit Bhalla
Geneoscopy
amit.bhalla@geneoscopy.com
Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Geneoscopy Wins Patent Trial and Appeal Board Decision, Invalidating All 20 Claims of Exact Sciences’ ’781 Patent
Decision removes key patent hurdle as Geneoscopy advances ColoSense, its RNA-based noninvasive colorectal cancer screening test
ST. LOUIS, Mo.—July 10, 2025 — Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health,today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a Final Written Decision following inter partes review (IPR), finding all 20 challenged claims of U.S. Patent No. 11,634,781 (the ’781 patent) unpatentable.
The PTAB’s ruling concluded that all claims of the ’781 patent are obvious considering prior art related to stool sample collection and processing. The decision to invalidate the ‘781 patent confirms Geneoscopy’s long-held position and clears the path for the continued commercialization of ColoSense.
“The PTAB’s final decision validates what we have believed all along—that the claims in the ’781 patent should never have been issued,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This outcome not only reinforces the strength of our position but helps ensure that invalid patents cannot be used to limit patient access to life-saving colorectal cancer screening options like ColoSense. It’s a critical step toward protecting patient choice and advancing high-quality, noninvasive screening solutions.”
Geneoscopy filed the IPR petition after Exact Sciences initiated a patent infringement suit in the U.S. District Court for the District of Delaware. The PTAB’s ruling bolsters the company’s defenses in that case and follows the Board’s earlier decision in February to institute review of a second patent asserted by Exact Sciences (U.S. Patent No. 11,970,746) on largely the same grounds on which the ‘781 patent was just invalidated. In parallel to the pending litigation, Geneoscopy has filed a countersuit alleging breach of contract, misappropriation of trade secrets, false advertising, and unfair competition.
About ColoSense
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.
A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.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. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
