New Test for Inflammatory Bowel Disease Cleared by FDA

San Diego, CA, US - November 16, 2016

Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, is pleased to announce the US Food and Drug Administration (FDA) clearance of QUANTA Lite Calprotectin Extended Range, an assay which aids in the diagnosis of Inflammatory Bowel Disease (IBD), and can help differentiate IBD from Irritable Bowel Syndrome (IBS).

The accurate detection of calprotectin levels can provide critical information to physicians determining the appropriate care of millions of patients suffering from gastrointestinal disorders. QUANTA Lite® Calprotectin Extended Range is a quantitative enzyme linked immunosorbent assay (ELISA) that detects calprotectin levels. Results can aid in the diagnosis of IBD (Crohn’s disease and ulcerative colitis) and help differentiate IBD from IBS in conjunction with other clinical and laboratory findings.

QUANTA Lite Calprotectin Extended Range offers a broader analytical measuring range compared with other FDA cleared assays. According to Michael Mahler, PhD, Vice President of Research and Development for Inova Diagnostics, "We are very pleased to launch this high performing assay to meet the increasing demand from laboratories worldwide. 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.”

KT Park, MD, MS, Chair of Clinical Care and Quality, NASPGHAN and Co-Director, Stanford Children's IBD Center at Stanford University School of Medicine commented, “Fecal calprotectin has revolutionized my clinical practice in two specific areas. 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.”

About Inova Diagnostics, Inc.

Inova Diagnostics is a privately held company headquartered in San Diego, California, and is a part of Werfen, a global leader in in vitro diagnostics (IVD) with a long term commitment to providing high quality, innovative solutions for hospitals and clinical laboratories to enhance patient care. Inova Diagnostics manufactures IVD systems and reagents for autoimmune disease that are used around the world, and is a leader in the development and commercialization of novel autoimmune technologies and diagnostic markers.

About QUANTA Lite Calprotectin Extended Range

QUANTA Lite Calprotectin Extended Range is a quantitative ELISA for detecting concentrations of fecal calprotectin to aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn’s disease and ulcerative colitis, and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other laboratory findings.

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