Introducing ColoSenseTM

The first FDA-approved RNA-based molecular screening test for the qualitative detection of colorectal cancer and advanced adenomas in average-risk individuals.

Learn what makes ColoSense different

Help us Close the Colorectal Cancer Screening Gap

Colorectal cancer is the second deadliest cancer in the US, causing more than 52,000 deaths each year.1 ColoSense was developed to address this problem.

  • There are 44 million unscreened Americans.2
  • Screening for colorectal cancer can lower colorectal cancer mortality by detection of treatable early-stage disease or by detection of precancerous lesions, which can prevent colorectal cancer development if removed.3
  • Although most colorectal cancers occur in adults older than 50 years, approximately 12% of all cases are observed in individuals younger than 50 years.1

Percentage of Eligible Adults Who Are Up To Date For Colorectal Cancer Screening, (US, 2021)4

45-49 20%
50-54 50%
55-64 70%
65-74 80%
75+ 70%
Age (years)

What Makes ColoSense Different?

ColoSense harnesses the power of RNA biomarkers to aid in the detection of colorectal cancer and advanced adenomas.

  • RNA biomarkers provide a dynamic view of disease activity, not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.5,6
  • ColoSense is a multi-target stool RNA (mt-sRNA) test engineered for the qualitative detection and stabilization of RNA signals.

A New Screening Test Powered by RNA

The ColoSense CRC-PREVENT clinical trial evaluated a large cohort of participants ages 45 years and older who represent a cross section of the intended use population for the test.7

  • CRC-PREVENT demonstrated the efficacy of ColoSense, a noninvasive, stool-based, at-home diagnostic screening test for the qualitative detection of colorectal cancer (CRC) and advanced adenomas (AA), also known as precancerous polyps, in average-risk individuals.
  • In average-risk individuals, sensitivity for detecting advanced adenomas was 45%.
  • More than 1,800 average-risk individuals, ages 45-49 (20% of study participants), were evaluated, demonstrating 100% sensitivity for CRC and 44% sensitivity for advanced adenomas.

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Intended Use/Indications for Use

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 45 years of age or older who are at typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.


  1. Siegel  RL, Miller  KD, Wagle  NS, Jemal  A.  Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17-48.
  2. US Census data, Geneoscopy estimates (includes US markets only)
  3. Cronin  KA, Scott  S, Firth  A,  et al.  Annual report to the nation on the status of cancer, part I: national cancer statistics. Cancer. 2022;128(24):4251-4284.
  4. American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025. Atlanta: American Cancer Society; 2023.
  5. 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.
  6. 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
  7. 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