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Inflammatory Bowel Disease Diagnostic Receives FDA Approval



The clinical diagnostic could help differentiate IBD from the closely-related irritable bowel syndrome (IBS).

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November 17, 2016 | by Sarah Hand, M.Sc.

The US Food and Drug Administration (FDA) has approved Inova Diagnostics’ assay, QUANTA Lite Calprotectin Extended Range, to help physicians diagnose inflammatory bowel disease (IBD). The clinical diagnostic could help differentiate IBD from the closely-related irritable bowel syndrome (IBS).

“We are very pleased to launch this high performing assay to meet the increasing demand from laboratories worldwide,” said Dr. Michael Mahler, Vice President of Research and Development for Inova Diagnostics. “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.”

By measuring calprotectin levels, physicians can determine the best treatment option from a patient suffering from a gastrointestinal disorder. Inova’s QUANTA Lite Calprotectin Extended Range using a quantitative enzyme linked immunosorbent assay (ELISA) to accurately detect calprotectin.

When used in combination with other clinical and laboratory tests, the diagnostic could help in the diagnosis of IBD, including Crohn’s disease and ulcerative colitis. Compared to other FDA-approved assays, QUANTA Lite Calprotectin Extended Range can detect a broader range of calprotectin levels.

“Fecal calprotectin has revolutionized my clinical practice in two specific areas,” said Dr. KT Park, Chair of Clinical Care and Quality, NASPGHAN and Co-Director, Stanford Children's IBD Center at Stanford University School of Medicine. “First, calprotectin measurements during patients' diagnostic workup, 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 inflammation. The improvements in quantitative range represented by Inova Diagnostics' new, FDA cleared assay is an update to the clinicians' toolkit for decision-making.”

Keywords: IBD, Diagnostic, FDA


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