Bridgewater, N.J., and Secaucus, N.J., Nov. 13, 2017 -- Clinical Genomics, a private company and Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced FDA clearance of InSure® ONE™, a convenient at-home collection, fecal immunochemical test (or FIT) intended to detect blood in stool, that may improve compliance for screening programs.
Clinical Genomics manufactures InSure FIT tests, including InSure ONE, which Quest provides to physicians and organized provider groups, including through specialized programs with Accountable Care Organizations (ACOs), across the United States. Insure ONE is expected to be commercially available in early 2018.
InSure ONE detects human hemoglobin from blood in fecal samples to aid in the detection of lower gastrointestinal bleeding. A number of medical conditions may be associated with lower gastrointestinal bleeding, including colorectal cancer, iron deficiency, anemia, diverticulitis, ulcerative colitis, polyps, and adenomas. InSure ONE requires sample collection from one bowel movement by the patient, versus the two samples required by InSure FIT, its predicate test. Unlike other FITs, InSure ONE only requires a sample of water from the toilet bowl. The toilet bowl water is collected after brushing the surface of the stool to release any blood into the surrounding water.
Annual FIT is guideline-recommended for screening programs for the early detection of adenomatous polyps, precursors to cancer, and colorectal cancer, in individuals of average risk starting at age 50 years. However, despite the availability of FIT and other screening options, low patient participation rates continue to be a major challenge for screening programs.
“InSure ONE was specifically designed with the user in mind,” said Mark Boyle, President of Clinical Genomics IVD. “A test that is easier for the patient to use is far more likely to be employed, which in turn may enhance screening rates and earlier detection of medical issues when they are more likely to be successfully treated.”
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