About InSure® ONE

Test Summary Fecal Globin by Immunochemistry (InSure®)

Early detection for a preventable cancer

Colorectal cancer that is caught in the early stages has a 5-year survival rate of over 90%.1 Yet, only 39% of cases2 are diagnosed in early stages due to low screening rates. When disease spreads to distant organs, the 5-year survival rate drops to 11%.3

InSure® ONE is a convenient, at-home fecal immunochemical test (FIT) kit that only requires water-based sampling of one bowel movement. Colorectal cancer screening has never been easier. Reach more patients with InSure® ONE.

Only 39% of cases2
are diagnosed

Accurate colorectal screening

InSure® ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples5, 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. The assay uses monoclonal antibodies to capture human hemoglobin on a test strip. Studies show that the InSure® ONE testing helps more people actually get the screening they need. FIT testing is supported by medical guidelines, including the American Cancer Society, the American College of Gastroenterology, and the US Preventive Services Task Force for early detection of Colorectal Cancer.3-6

What’s in the kit

InSure® ONE comes in a patient-friendly kit that contains everything necessary to collect a water-based sample and package it for shipping in an enclosed self-mailing envelope.

The kit includes

  • Patient instructions for use
  • A test card
  • 2 long-handled brushes
  • 2 waste bags

Patient-friendly collection

The convenient water-based collection method uses unique, patented brush sampling that doesn’t require any stool collection or handling. There are no dietary or medicinal restrictions. Patients collect 2 water-based samples from a single bowel movement. This patient-friendly approach to testing is associated with up to 66% greater patient compliance.7

How to order

Start ordering InSure® ONE kits using Quanum Lab Services Manager. If you don’t have an account, create one in less than 5 minutes by clicking GET ACCESS NOW.

Use test codes 11290 or 11293 (Medicare) for InSure® ONE kits, where you will find all patient instructions for specimen collection and for returning completed test kits. A completed requisition form from Quanum Lab Services Manager or your EMR should be printed and stapled to the reply form inside the kit before providing to patients.

References

  1. Altekruse SF, Kosary CL,, Krapcho M, et al (eds). SEER Cancer Statistics Review, 1975-2007. National Cancer Institute SEER website. http://seer.cancer.gov/csr/1975_2007/sections.html. Updated June 30, 2010. Accessed July 31, 2018.
  2. American Cancer Society. Colorectal Cancer Facts & Figures 2017-2019. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2017-2019.pdf. Published 2017. Accessed May 1, 2018.
  3. InSure® ONE K170548- Instructions for Use (IFU). November 30, 2017.
  4. InSure® FIT K002457 Fecal Immunochemical Test Immunoassay for human hemoglobin in stool. Product Instructions. Enterix, Edison, NJ. 2011.
  5. US Preventive Services Task Force Recommendation Statement JAMA. 2016;315(23):2564-2575.
  6. USPSTF Recommendation Statement JAMA. 2016;315(23):2564-2575.
  7. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017;112(7):1016-1030. doi: 10.1038/ajg.2017.174
  8. Cole SR, Young GP, Esterman A, Cadd B, Morcom J. A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer. J Med Screen. 2003;10(3):117-122.