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Inova Diagnostics Launches First FDA Cleared Calprotectin Extraction Device

San Diego - October 24, 2018

Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is proud to announce the clearance by the US Food and Drug Administration (FDA) of a Fecal Extraction Device for use in conjunction with QUANTA Flash® Calprotectin. QUANTA Flash Calprotectin aids in the diagnosis of inflammatory bowel disease (IBD) and helps differentiate IBD from irritable bowel syndrome (IBS). The Fecal Extraction Device is the first calprotectin extraction device to be FDA cleared.

The Fecal Extraction Device is a proprietary, accurate and easy to use device that provides significant workflow improvement to the laboratory compared with manual weighing of samples. The Fecal Extraction Device correlates very well to the manual weighing method, allows extracted sample to be stored up to 72 hours at room temperature, and can be placed directly on the BIO-FLASH system for convenient sample processing. The availability of the Fecal Extraction Device dramatically simplifies the extraction procedure and improves laboratory productivity.

About Inova Diagnostics

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 innovative solutions for hospitals and clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systems and reagents for autoimmune disease, and is a leader in the development and commercialization of novel autoimmune technologies and diagnostic markers. Further information about Inova Diagnostics can be found at www.inovadx.com.

About QUANTA Flash Calprotectin

QUANTA Flash Calprotectin is a chemiluminescence immunoassay performed on BIO-FLASH for the detection of fecal calprotectin in human stool samples. High concentrations of fecal calprotectin, in conjunction with clinical findings and other laboratory tests, may assist in the diagnosis and management of IBD (ulcerative colitis and Crohn's disease).

About BIO-FLASH

BIO-FLASH is a random access chemiluminescent instrument for the autoimmune laboratory which delivers results in as little as 30 minutes. BIO-FLASH offers a wide analytical measuring range and precise quantification for greater confidence in results, and is a progressive step forward to handle routine, specialized and STAT immunology tests.

BIO-FLASH is a registered trademark of Biokit S.A. and QUANTA Flash is a trademark of Inova Diagnostics, Inc. © 2018 Inova Diagnostics, Inc. All rights reserved.

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