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InSure One is easy

The American Cancer Society (ACS) recommends people at average risk for developing colorectal cancer (CRC) begin screening at age 45. [1]

InSure One is the only Fecal Immunochemical Test (FIT) that is performed using toilet bowl water collected from a single bowel movement. Just gently brush the surface of the stool for about 5 seconds with a long handled blue brush, and then collect the toilet water on the test card.

2023 estimated new cases & deaths

Total diagnosed colorectal cancer cases [2]

Diagnosed colorectal cancer cases under age 50 [2]

Estimated expected deaths from colorectal cancer in 2023 [2]

5-year survival rates for CRC

%

Localized [3]

%

Regional [3]

%

Distant [3]

CRC screening adherence

%

Eligible adults not up to date with CRC screenings [2]

%

Eligible adults aged 50-54 years are not up to date with CRC screening [2]

CRC screenings can help save lives

Regular Colorectal cancer (CRC) screening may help reduce mortality rates and has the potential to save lives. [4]
FIT was recommended as a Tier 1 testing option for colorectal cancer screening programs, along with colonoscopy, by the USPSTF in 2017. Fecal Immunochemical Tests (FIT) are recommended by medical guidelines for use in colorectal cancer screening programs and are recognized as being highly effective when repeated annually. Additional recommendation details by the USPSTF are listed in the table below. [6]
Screening Method Frequency Evidence of efficacy
Stool Based Tests
High-sensitivity gFOBT Every Year
  • Evidence from RCTs that gFOBT reduces colorectal cancer mortality
  • High-sensitivity versions (eg, Hemoccult SENSA) have superior test performance characteristics than older tests (eg, Hemoccult II), although there is still uncertainty about the precision of test sensitivity estimates. Given this uncertainty, it is unclear whether high-sensitivity gFOBT can detect as many cases of advanced adenomas and colorectal cancer as other stool-based tests
FIT Every Year
  • Evidence from 1 large cohort study that screening with FIT reduces colorectal cancer mortality
  • Certain types of FIT have improved accuracy compared to gFOBT and HSgFOBT (20 μg hemoglobin per gram of feces threshold was used in the CISNET modeling)
sDNA-FIT Every 1 to 3 years
  • Improved sensitivity compared with FIT per 1-time application of screening test
  • Specificity is lower than that of FIT, resulting in more false-positive results, more follow-up colonoscopies, and more associated adverse events per sDNA-FIT screening test compared with per FIT test
  • Modeling suggests that screening every 3 y does not provide a favorable (ie, efficient) balance of benefits and harms compared with other stool-based screening options (ie, annual FIT or sDNA-FIT every 1 or 2 y)
  • Insufficient evidence about appropriate longitudinal follow-up of abnormal findings after a negative follow-up colonoscopy
  • No direct evidence evaluating the effect of sDNA-FIT on colorectal cancer mortality
Direct Visualization Test
Colonoscopy Every 10 years
  • Evidence from cohort studies that colonoscopy reduces colorectal cancer mortality
  • Harms from colonoscopy include bleeding and perforation, which both increase with age
CT colonography Every 5 years
  • Evidence available that CT colonography has reasonable accuracy to detect colorectal cancer and adenomas
  • No direct evidence evaluating effect of CT colonography on colorectal cancer mortality
  • Limited evidence about the potential benefits or harms of possible evaluation and treatment of incidental extracolonic findings, which are common. Extracolonic findings detected in 1.3% to 11.4% of examinations; <3% required medical or surgical treatment
Flexible sigmoidoscopy Every 5 years
  • Evidence from RCTs that flexible sigmoidoscopy reduces colorectal cancer mortality
  • Risk of bleeding and perforation but less than risk with colonoscopy
  • Modeling suggests that it provides fewer life-years gained alone than when combined with FIT or in comparison to other strategies
Flexible sigmoidoscopy with FIT Flexible sigmoidoscopy every 10 y plus FIT every year
  • Evidence from RCTs that flexible sigmoidoscopy + FIT reduces colorectal cancer mortality
  • Modeling suggests combination testing provides benefits similar to those of colonoscopy, with fewer complications
  • Risk of bleeding and perforation from flexible sigmoidoscopy but less than risk with colonoscopy

Not all FIT are created equal

InSure® ONE™ is highly accurate. In a recent study demonstrated that InSure® FIT™ was found to be significantly more sensitive for advanced colorectal neoplasia than OC-FIT CHECK and Hemoccult II SENSA. [5]
Sensitivity For Detecting Advanced Colorectal Neoplasia

Insure FIT OC-FIT-CHEK Hemoccult II SENSA
26.3% 15.1% 7.4%
95% CI 15.9–40.7 95% CI 6.7–26.1 95% CI 1.9–17.0

Specificities were relatively high for all tests (between 96.8% and 98.6%)

A test designed for easy processing

InSure One is a lateral flow test that does not require any special lab equipment to process. Tests can be processed in office or lab with FOBT controls following collection.

View the Patient instruction and Sample Collection video:

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Citations
  1. The American Cancer Society medical and editorial content team. Colorectal Cancer Guideline | Accessed April 4, 2023 | https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/acs-recommendations.html
  2. Siegel, RL, Wagle, NS, Cercek, A, Smith, RA, Jemal, A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023; 1- 22. doi:10.3322/caac.21772
  3. American Cancer Society. Survival Rates for Colorectal Cancer | Accessed April 4, 2023 | https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html
  4. Sharma KP, Grosse SD, Maciosek MV, et al. Preventing Breast, Cervical, and Colorectal Cancer Deaths: Assessing the Impact of Increased Screening. Preventing Chronic Disease. 2020;17. doi:https://doi.org/10.5888/pcd17.200039
  5. Shapiro JA, Bobo JK, Church TR, et al. A Comparison of Fecal Immunochemical and High-Sensitivity Guaiac Tests for Colorectal Cancer Screening. Am J Gastroenterol. 2017;112(11):1728-1735. doi:10.1038/ajg.2017.285
  6. U.S. Preventive Services Task Force. Recommendation | United States Preventive Services Taskforce | Published May 18, 2021. Accessed April 4, 2023 | https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening