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DESIGNED TO FIT INTO EVERYDAY LIFE.

InSure® ONE™

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).

Frequently asked questions

Why prescribe the InSure ONE test?
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. 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.
What are the advantages of using InSure ONE?
When it comes to colorectal cancer screening programs, lack of patient compliance is a major challenge for physicians. Users may be reluctant to perform a test that requires unpleasant stool collection and smearing of feces. InSure ONE is the easiest fecal immunochemical test available on the market today, requiring the patient to collect a sample of water only. Using a long handled brush, users simply sample the water from the toilet bowl following a single bowel movement. Sample collection is completed in minutes and does not require the user to collect, handle or smear fecal matter. There are no diet or drug restrictions associated with using InSure ONE. A 66% increase in user participation was observed in a study comparing InSure with a commercially available gFOBT test, in which 74% of participants preferred collecting toilet water using the InSure ONE ‘brush technology’ versus collecting stool with a stick.
Who should be screened?
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.
Where can I get the InSure ONE test?
For information on how to order the InSure ONE test please complete the Information Request Form or call us at 800-531-3681.
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?
Unlike the InSure ONE test, stool DNA tests require patients to collect an entire bowel movement in a kit and send the sample to a laboratory for testing. InSure ONE is the easiest fecal immunochemical test available on the market today. Using a long handled brush, users simply sample the water from the toilet bowel following a single bowel movement. Sample collection is completed in minutes and does not require the user to collect, handle or smear fecal matter. 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. FIT fecal DNA tests are recommended as tier 2 screening options by the US Multi Society Task Force for Colorectal Cancer for asymptomatic persons beginning at age 50. 1 The guidelines go on to state … “In a large screening colonoscopy study, patients underwent FIT, the combined FIT-fecal DNA test, and colonoscopy. FIT- fecal DNA test had a 1-time sensitivity for CRC of 92%. FIT assay tested in the study had 73.8% sensitivity for cancer, suggesting that most cancer sensitivity of the FIT-fecal DNA test can be achieved without addition of DNA markers”. 1 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
Is the InSure ONE test covered by insurance?
Most insurance providers do cover the InSure ONE test under their preventive care services. Patients should contact their insurance provider to ensure that the InSure ONE is covered by their insurance policy.
Can a digital rectal exam sample be used on the InSure ONE Test Card?
No. The InSure ONE test has not been designed for use with a digital rectal exam. Both the American Cancer Society and United States Preventative Service Task Force state that a FOBT or FIT done during a digital rectal exam in the doctor’s office IS NOT adequate for screening.1,2 Research has shown that colorectal cancer sensitivity of a FOBT is as low as 4.9% when used with a single digital rectal exam. 6
Do patients need to go on a special diet or discontinue medications before or during collecting the sample?
There are no dietary or drug restrictions associated with using InSure ONE.
Should the test be prescribed to patients with bleeding hemorrhoids?
No. Since the InSure ONE test detects blood in and around the stool, active bleeding from hemorrhoids could produce a false positive result.
Can patients do the test if menstruating?
No. Since the InSure ONE test detects blood in and around the stool, bleeding during menstruation can produce a false positive result.  The test should not be performed three days prior to, during, and three days after a patient’s menstrual period.
Should patients use the InSure ONE test if they see blood in the toilet bowl?
If blood is visible in the toilet bowl the InSure ONE test should NOT be performed and instead patients should report the presence of blood to their physician. The InSure ONE test has been designed to detect hidden (occult) blood and at certain high concentrations of blood it may yield a negative result due to the prozone effect, as is the case with all FIT tests.
Does a positive result mean that the patient has colorectal cancer?
InSure ONE is a highly accurate test for detecting blood in fecal samples. A positive result only indicates that blood was detected in the sample and this may be an indication of lower gastrointestinal bleeding which may be associated with disorders such as diverticulitis,ulcerative colitis, polyps, colorectal cancers or large adenomas that bleed. 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.
Does a negative result mean that the patient does not have colorectal cancer?
A negative result means that human hemoglobin was not detected in the sample collected by the patient. Colorectal lesions, including some polyps and colorectal cancers, may bleed intermittently, or not at all. Additionally, blood may not be uniformly distributed in or on the stool and a test result may be negative even when blood or lower gastrointestinal disease is present. InSure ONE is designed for preliminary screening and is not intended to replace diagnostic procedures such as colonoscopy or sigmoidoscopy in combination with double contrast barium x-ray.
I performed the test development procedure in accordance with the instructions, but the test has not developed. What should I do?
Check that the patient did not apply excess specimen. Remember that the sample is collected by brushing the surface of the stool for 5 seconds. Proper sample application requires that any excess water or stool is removed by gently shaking the brush prior to transferring the sample to the Test Card. Therefore, there should not be any significant amount of fecal matter on the Test Card. If excess specimen has been collected apply 2 more drops of run buffer and wait an additional 5 minutes for test development. If the test continues to not develop, the patient should be supplied another collection kit and instructed to perform sample collection in accordance with the instructions for use. If there is no excess specimen on the Test Card and the test still does not develop 5 minutes after the application of 2 additional drops of run buffer, please contact Technical Services: 1-800-531-3681.
I have test components from a FIT or FOBT manufactured by another company. Can they be used to develop a returned, completed Test Card?
No. Only components supplied in the InSure ONE Developer Kit can be used to develop returned, completed Test Cards.
How do I know if the test has fully developed after 5 minutes?
A white to light pink background color in the negative background control area (region just below the Control Line on the Test Strip) indicates that the reagents and conjugate-sample complex flowed properly. If distinct areas of color (dark pink) remain in the window below the Control Line, the test is invalid. The built-in procedural controls should be observed for each patient test performed in order to monitor test validity.
Are the external controls available for InSure ONE?
Yes, Clinical Genomics has external controls available.
I have external controls manufactured by another company. Can I use them with InSure ONE?
No.  External controls for other FOBT or FIT products manufactured by other companies are not to be used with the InSure ONE product.
How do I dispose of used test cards and unused test components?
Discard used test cards and any remaining unused test components in accordance with internal procedures for the disposal of clinical waste.  All specimens and used assay materials should be treated as if they are potentially infectious.  Run buffer contains non-hazardous concentrations of sodium azide, which can react with metal pipes to form explosive metal azides.  Upon disposal, flush with large volumes of water to prevent azide buildup.

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