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Inova Receives FDA Clearance for Fecal Extraction Device

NEW YORK (360Dx) — Inova Diagnostics announced on Wednesday that it has received clearance from the US Food and Drug Administration for a fecal extraction device designed for use with the firm's Quanta Flash Calprotectin assay.

The assay, which was cleared by the FDA earlier this year, detects fecal calprotectin in human stool samples in order to help physicians differentiate inflammatory bowel disease from irritable bowel syndrome.

According to San Diego-based Inova, the newly cleared fecal extraction device offers a simplified workflow versus manually weighing samples, and allows an extracted sample to be stored up to 72 hours at room temperature and to be placed directly on the company's Bio-Flash chemiluminescent analyzer.