Sexuality – Lifestyle

Geneoscopy’s ColoSense® Test Included as a Preferred Option in the American Cancer Society Colorectal Cancer Screening Guidelines Update

Business Wire

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.

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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.

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

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