Geneoscopy

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

by Geneoscopy

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.)).

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

by Geneoscopy

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.

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

by Geneoscopy

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.

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.

Geneoscopy Contacts:
Media
Andrea Sampson, Sampson PR Group
asampson@sampsonprgroup.com

Investor Relations
Amit Bhalla, CFO, Geneoscopy
amit.bhalla@geneoscopy.com

by Geneoscopy

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.

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.

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

by Geneoscopy

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.

Geneoscopy Investor Relations Contact
Amit Bhalla
Geneoscopy
amit.bhalla@geneoscopy.com

Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

by Geneoscopy

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.

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.

Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

by Geneoscopy

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.

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.

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

by Geneoscopy

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.”

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.

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

by Geneoscopy