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Inova Diagnostics Gets FDA Clearance for Quanta Flash Calprotectin

NEW YORK (360Dx) – Inova Diagnostics announced today it has received US Food and Drug Administration clearance for its Quanta Flash Calprotectin assay for the detection of fecal calprotectin in human stool samples.

The test is the first fully automated, random access calprotectin assay available in the US, the company said.

Physicians use assays that detect calprotectin levels when treating patient with gastrointestinal disorders. Quanta Flash Calprotectin helps physicians differentiate inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS). Timely differential diagnosis of gastrointestinal pain can help patients avoid unnecessary procedures, according to Inova Diagnostics.

Quanta Flash Calprotectin provides precise quantification with an analytical measurement range of up to 3500 mg/kg. The assay 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.

K.T. Park, chair of clinical care and quality, for the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, and codirector of Stanford Children's IBD Center at Stanford University School of Medicine, said fecal calprotectin has had a large impact on 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," Park said. "Calprotectin testing supports a patient-centered, proactive approach to disease management, allowing accurate detection of indolent and often-missed inflammation."

Based in San Diego, Inova Diagnostics manufactures in vitro diagnostic systems and reagents for autoimmune disease. It is part of Werfen.