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
Modeling Study Published in Clinical Gastroenterology and Hepatology Validates Geneoscopy’s ColoSense® Real-World Screening Impact
ST. LOUIS, Mo.—June 24, 2025 — Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced the publication of a new study in Clinical Gastroenterology and Hepatology showing that its FDA-approved multitarget stool RNA (mt-sRNA) test, ColoSense®, achieved notable clinical benefits among colorectal cancer (CRC) screening tests when modeled at real-world adherence levels.
In the absence of a head-to-head study comparing CRC screening options, this peer-reviewed modeling study, titled “Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia,” provides valuable insights by evaluating five CRC screening strategies for patients aged 45 and older. Using a 10-year Markov model, researchers simulated disease progression, comparing mt-sRNA, two mt-sDNA tests, a blood-based test, and a fecal immunochemical test (FIT), and reported findings similar to previously published modeling studies.1-3 When test performance was normalized to better reflect the age of the intended use population, the clinical and economic benefits of ColoSense were amplified.
At real-world adherence of 60% (the typical rate observed in practice), the modeling study results showed that ColoSense reduced CRC deaths by 14% compared to FIT, by 19% and 23% compared to the mt-sDNA tests, and by 86% compared to a blood-based test.1 While FIT remained the most cost-effective strategy overall, ColoSense was the most cost-effective among molecular tests across all levels of screening adherence.
“Study cohorts often don’t reflect the target patient population, which can skew results and limit clinical relevance,” said Dr. Erica Barnell, co-author and Chief Science and Medical Officer at Geneoscopy. “These data reinforce the need to design studies around real-world populations. ColoSense was developed with that in mind, delivering strong performance across diverse groups, including younger adults who are often under-represented in clinical trials.”
This study builds on prior research by using a model that normalizes the age of the populations in independent, peer-reviewed studies to better reflect the general screening population. Given that many assays rely on methylation-based biomarkers, whose sensitivity is lower in younger individuals,4,5 adjusting sensitivity estimates for colorectal cancer and advanced adenomas is essential for accurate clinical and economic assessment.
ColoSense is included in the 2025 National Comprehensive Cancer Network (NCCN) guideline update, highlighting the strength of its clinical evidence and the robust science behind Geneoscopy’s RNA-based approach. As the only FDA-approved stool RNA test for CRC screening, ColoSense represents a significant step forward in noninvasive screening methods, underscoring the need for accessible alternatives that can increase compliance, especially among groups less likely to pursue colonoscopy.
*All data used in the study were derived from independent, non-head-to-head clinical trial results.
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
References
- Shaukat A, Levin TR, Liang PS, Weiss JM, Smare C, Boller E, Venkatachalam M, Barnell EK. Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia. Clinical Gastroenterology and Hepatology. 2025. doi: https://doi.org/10.1016/j.cgh.2025.06.006.
- Ladabaum U, Mannalithara A, Schoen RE, Dominitz JA, Lieberman D. Projected impact and cost-effectiveness of novel molecular blood-based or stool-based screening tests for colorectal cancer. Ann Intern Med. 2024;177(12):1610-1620. doi: 10.7326/ANNALS-24-00910. Epub 2024 Oct 29. PMID: 39467291.
- Rui M, Wang Y, You JH. Novel non-invasive tests for colorectal cancer screening – a cost-effectiveness analysis. Cancer Epidemiol Biomarkers Prev. 2025;OF1–OF11. doi:10.1158/1055-9965.EPI-24-1549.
- Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, Boardman LA, Thibodeau SN, et al. Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research. 2012;72(8_Supplement):3572–3572. https://doi.org/10.1158/1538-7445.am2012-3572.
- Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. Aberrantly methylated gene marker levels in stool: effects of demographic, exposure, body mass, and other patient characteristics. J Mol Biomark Diagn. 2012;3:133. doi:10.4172/2155-9929.1000133
Geneoscopy’s RNA-based ColoSense® Test Included in Latest National Comprehensive Cancer Network® (NCCN) Guidelines
ColoSense recommended as a first-line test for colorectal cancer screening, with a three-year screening interval
ST. LOUIS, Mo.—June 3, 2025 — Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that its ColoSense® test has been included in the National Comprehensive Cancer Network® (NCCN) Guidelines for Colorectal Cancer (CRC) Screening as a first-line test for average-risk patients, supporting its role as a screening alternative for individuals aged 45 years and older. ColoSense is a noninvasive stool-based test for detecting CRC and advanced adenomas, and is the only FDA-approved screening test utilizing stool RNA biomarkers, which are not subject to age-related methylation.¹,²
The NCCN Guidelines are comprehensive, evidence-based recommendations to support the prevention, diagnosis, and treatment of more than 97% of cancers affecting patients in the United States. They are regularly updated to reflect the latest scientific evidence and improve the quality and consistency of cancer care.
“The NCCN Guidelines are among the most trusted clinical resources in oncology, and the addition of ColoSense is a powerful validation of its clinical performance,” said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. “As the first and only FDA-approved stool RNA screening test for colorectal cancer, this affirms the scientific rigor behind our technology and reinforces the importance of noninvasive modalities in expanding access and improving screening compliance, especially among populations less likely to undergo colonoscopy.”
ColoSense’s inclusion in the NCCN Guidelines is based on data from Geneoscopy’s CRC-PREVENT pivotal study, which was published in the Journal of the American Medical Association (JAMA).³ Unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs, nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study demonstrated ColoSense’s ability to detect CRC with 94% sensitivity, identifying 100% of CRC in Stage I. Additionally, ColoSense detected 46% of advanced adenomas, when the disease is most preventable.
“The NCCN Guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,” said Matt Sargent, Chief Commercial Officer of Geneoscopy. “Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines.”
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
References
- Ahlquist, D. A., Taylor, W. R., Yab, T. C., Devens, M. E., Mahoney, D. W., Boardman, L. A., Thibodeau, S. N., Zou, H., Michael, D., Berger, B. M., & Lidgard, G. P. (2012). Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research, 72(8_Supplement), 3572–3572. https://doi.org/10.1158/1538-7445.am2012-3572
- Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. (2012) Aberrantly Methylated Gene Marker Levels in Stool: Effects of Demographic, Exposure, Body Mass, and Other Patient Characteristics. J Mol Biomark Diagn 3:133. doi:10.4172/2155-9929.1000133
- 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 Sibling Co-founders Named Finalists for EY Entrepreneur Of The Year® 2025 Heartland Award
Entrepreneur Of The Year celebrates ambitious entrepreneurs who are shaping the future
ST. LOUIS, Mo. – April 29, 2025 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that co-founders Andrew Barnell, MBA, and Erica Barnell, M.D., Ph.D., have been named finalists for the Ernst & Young (EY) Entrepreneur Of The Year® 2025 Heartland Award.
Entrepreneur Of The Year is one of the preeminent competitive business awards recognizing leaders of high-growth companies that are creating a better future through innovation, purpose, and transformative impact. This recognition places Geneoscopy’s co-founders alongside entrepreneurs and leaders in the Heartland region, which includes Minnesota, Kansas, Missouri, Iowa, Nebraska, North Dakota, and South Dakota.
“Being named a finalist is a testament to the hard work of Geneoscopy’s entire team,” said Andrew Barnell, CEO of Geneoscopy. “Erica and I have always focused on building a strong business foundation—scaling our operations, hiring the right people to advance our mission and technology, establishing key partnerships, and setting the stage for long-term growth. We’re honored to be recognized by EY among such an inspiring group of entrepreneurs.”
Erica and Andrew’s leadership and vision have been instrumental in Geneoscopy’s growth and advancement of non-invasive diagnostics for gastrointestinal health. Through the development of its novel platform for isolating human RNA from stool samples, Geneoscopy has developed FDA-approved ColoSense®, a highly effective screening solution for colorectal cancer. The company is also expanding its diagnostic pipeline to address critical unmet needs in inflammatory bowel disease.
“Building Geneoscopy with my brother has been an incredible journey,” said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. “From early research efforts to developing a clinically validated technology, it has been deeply rewarding to see our vision translate into real-world impact for patients.”
Regional award winners will be announced on Thursday, June 19, during a special celebration in Minneapolis. Finalists become lifetime members of an esteemed community of Entrepreneur Of The Year alumni from around the world. The winners will then be considered by the National judges for the Entrepreneur Of The Year National Awards, which will be presented in November at the annual Strategic Growth Forum®, one of the nation’s most prestigious gatherings of high-growth, market-leading companies.
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.
Sponsors
Founded and produced by Ernst & Young LLP, the Entrepreneur Of The Year Awards include presenting sponsors PNC Bank, Cresa, LLC, Marsh USA and SAP. In the Heartland, sponsors also include Twin Cities Business, Padilla and Brillect.
About Entrepreneur Of The Year
Founded in 1986, Entrepreneur Of The Year has celebrated more than 11,000 ambitious visionaries who are leading successful, dynamic businesses in the US, and it has since expanded to nearly 60 countries globally.
The US program consists of 17 regional programs whose panels of independent judges select the regional award winners every June. Those winners compete for national recognition at the Strategic Growth Forum® in November where National finalists and award winners are announced. The overall National winner represents the US at the EY World Entrepreneur Of The Year™ competition. Visit ey.com/us/eoy.
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Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Geneoscopy Appoints Amit Bhalla as Chief Financial Officer to Advance Strategic Growth and Support Commercialization Efforts
ST. LOUIS, Mo. – April 2, 2025 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced the appointment of Amit Bhalla as Chief Financial Officer (CFO). Bhalla brings more than 25 years of experience in healthcare finance, strategy, and investment to support Geneoscopy’s continued expansion, including the commercial launch of ColoSense®, the company’s RNA-based, non-invasive colorectal cancer screening test.
“Amit’s extensive financial leadership and deep understanding of the healthcare landscape will be invaluable as we scale our operations and advance our mission of improving patient outcomes through innovative diagnostic solutions,” said Andrew Barnell, Chief Executive Officer of Geneoscopy. “Following our recent $105 million Series C financing, Amit’s expertise will be instrumental in optimizing our financial strategy as we continue our work to bring ColoSense to market and progress our pipeline of products for inflammatory bowel disease (IBD).”
Bhalla most recently served as Executive Vice President and CFO at Sampled, a global biorepository and laboratory, where he led the financial, supply chain, and facilities operations. Before that, Bhalla served as Vice President of Global Strategy & Development and was a member of the Executive Management Committee at Becton Dickinson. His career also includes almost two decades on Wall Street as a lead healthcare analyst for Lord Abbett’s Value Funds, Director of Equity Research at Citi, and Vice President at Morgan Stanley, where he covered the life science tools, diagnostics, and medical device industries.
“This is an exciting time to join Geneoscopy’s leadership team, and I look forward to leveraging my background and experience to support its growth trajectory,” said Bhalla. “With a strong financial foundation, a differentiated solution for colorectal cancer screening, and the resources to drive meaningful innovation, the company is well-positioned to transform gastrointestinal diagnostics, bringing life-changing solutions to more patients.”
Geneoscopy recently secured $105 million in Series C financing to support the commercial launch of ColoSense, which received FDA approval in May 2024 as a noninvasive colorectal cancer screening test for eligible adults. The funding will also accelerate Geneoscopy’s precision medicine approach for IBD and further advance its proprietary RNA technology platform.
.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 GI disease areas. 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