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Inova Diagnostics gets FDA nod for first fully automated and random access Calprotectin test

Published 04 January 2018

Inova Diagnostics has secured approval from the the US Food and Drug Administration (FDA) for the QUANTA Flash Calprotectin test.

QUANTA Flash Calprotectin aids in the diagnosis of inflammatory bowel disease (IBD) and helps differentiate IBD from irritable bowel syndrome (IBS).

QUANTA Flash Calprotectin is one of 29 FDA cleared assays available on BIO-FLASH®, a random access chemiluminescent instrument, and can be run simultaneously with other QUANTA Flash assays. QUANTA Flash Calprotectin is the first fully automated, random access calprotectin assay available in the US.

Accurate detection of calprotectin levels can provide essential information for practitioners who are treating the millions of patients with gastrointestinal disorders. Timely differential diagnosis of gastrointestinal pain is crucial in order to provide appropriate care and avoid unnecessary procedures that lead to increased health care costs.

QUANTA Flash Calprotectin provides precise quantification, with an analytical measurement range of up to 3500 mg/kg. With its wide dynamic range, high precision, and fast turn-around time, QUANTA Flash Calprotectin can improve patient care while helping to 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. 

 Calprotectin measurements during patients' diagnostic workup when the diagnosis could be either IBS or IBD provide direction and important information prior to endoscopic evaluations. Calprotectin testing supports a patient-centered, proactive approach to disease management, allowing accurate detection of indolent and often-missed inflammation.

 The highly accurate QUANTA Flash Calprotectin assay offered by Inova Diagnostics, with a broad quantitative range, is an asset to the clinicians' decision-making process."



Source: Company Press Release