FDA Approves New Test to Help Diagnose IBD, Show it is Different from IBS

FDA Approves New Test to Help Diagnose IBD, Show it is Different from IBS
Inova Diagnostics, a developer of autoimmune diagnostics, announced that the U.S. Food and Drug Administration has cleared QUANTA Lite Calprotectin Extended Range, an assay to diagnose  inflammatory bowel disease (IBD) and to help differentiate IBD from irritable bowel syndrome (IBS). QUANTA Lite is a quantitative enzyme-linked immunosorbent assay (ELISA) designed to detect concentrations of fecal calprotectin to aid in the diagnosis of IBDs, in particular Crohn’s disease and ulcerative colitis. The technology also is capable of differentiating IBD from IBS, which is a non-inflammatory "functional disorder," meaning that its symptoms don’t have an identifiable cause. "We are very pleased to launch this high-performing assay to meet the increasing demand from laboratories worldwide," said Michael Mahler, PhD, Inova’s vice president of research and development, in a press release. Mahler said he believes QUANTA Lite offers a broader analytical measuring range compared to other FDA-approved assays. "Gastrointestinal pain is a common reason for seeking medical attention. Inaccurate diagnosis at the screening level can contribute to unnecessary procedures and increased healthcare costs. QUANTA Lite Calprotectin Extended Range can improve care while helping reduce costs,” Mahler said. "Fecal calprotectin has revolutionized my clinical practice in two specific areas. First, calprotectin measurements during patients' diagnostic work-up, particularly when the diagnosis could be either IBS or IBD, provide direction and important information prior to endoscopic evaluations. Second, calprotectin follow-up testing in IBD patients supports a patient-centered, proactive approach to disease management, allowing accurate detection of indolent and often-missed inflamma
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