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United States : Clinical Genomics and Quest Diagnostics announce FDA 510(K) clearance of InSure ONE.

Clinical Genomics, a private company and Quest Diagnostics, 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.

InSure ONE is a significant step forward for the InSure product line and FIT testing in general because it addresses several factors that may inhibit screening, said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics. As a leader in oncology diagnostic services, we look forward to facilitating access to this new, more convenient product. It will be a particularly valuable asset in our consultative solution for ACOs, through which we provide supportive services to enhance screening rates so ACOs are more likely to meet quality metrics and associated value-based reimbursement.

Quest Diagnostics provides several capabilities to address gaps in care and enhance the patient experience, including patient outreach programs, to encourage colorectal cancer screening using the InSure product line. Organized provider groups, including ACOs, whose targeted populations fulfill screening guidelines and associated quality scores may be more likely to achieve positive medical outcomes and increased incentive based economics under value-based care.

FIT, along with colonoscopy, was recently recommended as Tier 1 preferred tests for colorectal cancer screening programs by the U.S. Multi-Society Task Force. This panel of expert gastroenterologists representing the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy, considers FIT an essential element of colorectal cancer screening armamentarium for all practitioners. According to the U.S. MSTF recommendations, FIT is a non-invasive, and low cost test that has been shown to be highly effective when repeated annually. Annual testing by FIT is also recommended by the American Cancer Society.

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Publication:Mena Report
Date:Nov 17, 2017
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