DESIGNED TO FIT INTO EVERYDAY LIFE.
InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. The InSure ONE test is used to aid in the detection of lower gastrointestinal bleeding.
When to use InSure ONE?
The American Cancer Society (ACS) recommends both men and women at average risk for developing colorectal cancer (CRC) beginning screening at age 50. InSure ONE is a highly accurate test for detecting blood in fecal samples, which may be an indication of lower gastrointestinal bleeding associated with disorders such as diverticulitis, ulcerative colitis, polyps, colorectal cancers or large adenomas that bleed.
Colorectal cancer screening guidelines
Fecal immunochemical tests are recommended by medical guidelines for use in colorectal cancer screening programs and are recognized as being highly effective when repeated annually.
- FIT is supported by medical guidelines, including The American Cancer Society, The American College of Gastroenterology and the USPSTF, for use colorectal cancer screening programs.
- The U.S. Multi-Society Task Force for Colorectal Cancer recommends colorectal cancer (CRC) screening begin at age 50 years in asymptomatic persons, with colonoscopy every 10 years or FIT annually as first option, Tier 1 tests for screening for colorectal neoplasia. Download Guidelines Summary PDF
Key benefits of InSure ONE
- InSure ONE is the easiest FIT on the market, and may improve patient compliance. It is the only test that uses a toilet water sample; there is no need to collect stool in a sling or bucket, or sample feces directly; (compare with competing FIT and FIT-Fecal DNA tests).Using the brush supplied in the collection kit, enables the patient to brush around the stool sample in the toilet bowl and collect a water sample.
- InSure ONE is performed with a single bowel movement; (compare this with competing gFOBTs which require 2 or 3 separate bowel movements).
- Low cost; (compare with FIT Fecal DNA test which is approximately 10 times the cost and patients may incur out of pocket costs for screening).
- Highly accurate; recent study demonstrated that InSure FIT has significantly higher sensitivity for advanced colorectal neoplasia than two other FOBTs (i.e. OC FIT-CHEK and Hemoccult II SENSA)
- InSure ONE is an FIT, which is recommended as a Tier 1 testing option for colorectal cancer screening programs, along with colonoscopy, by the USMSTF in 2017 1 (compare with FIT Fecal DNA test, recommended as a Tier 2 option).
How to process a sample
Frequently asked questions
Why prescribe the InSure ONE test?
What are the advantages of using InSure ONE?
Who should be screened?
Where can I get the InSure ONE test?
How is the InSure ONE test different from other fecal occult blood tests (FOBTs)?
- InSure ONE is the only FIT that is performed using toilet water collected from a single bowel movement
- NO stool collection or handling of feces required
- There are no diet or drug restrictions associated with using InSure ONE
- 66% increase in user compliance observed in peer-reviewed study
How is the InSure ONE test different from a stool DNA (sDNA) test?
Is the InSure ONE test covered by insurance?
Can a digital rectal exam sample be used on the InSure ONE Test Card?
Do patients need to go on a special diet or discontinue medications before or during collecting the sample?
Should the test be prescribed to patients with bleeding hemorrhoids?
Can patients do the test if menstruating?
Should patients use the InSure ONE test if they see blood in the toilet bowl?
Does a positive result mean that the patient has colorectal cancer?
Does a negative result mean that the patient does not have colorectal cancer?
I performed the test development procedure in accordance with the instructions, but the test has not developed. What should I do?
I have test components from a FIT or FOBT manufactured by another company. Can they be used to develop a returned, completed Test Card?
How do I know if the test has fully developed after 5 minutes?
Are the external controls available for InSure ONE?
I have external controls manufactured by another company. Can I use them with InSure ONE?
How do I dispose of used test cards and unused test components?
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