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New Random Access Chemiluminescent Assay for Inflammatory Bowel Disease Launched
MARCH 14, 2017 - Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, is pleased to announce the launch of QUANTA Flash® Calprotectin, an assay which aids in the diagnosis of Inflammatory Bowel Disease (IBD), and can help differentiate IBD from Irritable Bowel Syndrome (IBS). The assay is now available in territories where diagnostic products with CE mark may be marketed. QUANTA Flash Calprotectin is one of 32 CE marked assays available on BIO-FLASH®, a random access chemiluminescent instrument, and can be run simultaneously with other QUANTA Flash assays.
First automated ANCA IFA assays cleared by FDA
FEBRUARY 6, 2017 - Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, announced today that the United States Food and Drug Administration (FDA) has granted 510(k) clearance of NOVA Lite® DAPI ANCA (Ethanol) and NOVA Lite® DAPI ANCA (Formalin) Kits for use with NOVA View®, a digital IFA (Immunofluorescence Assay) microscope. NOVA Lite DAPI ANCA Kits are the first FDA cleared reagents for the detection of anti-neutrophil cytoplasmic antibodies (ANCA) on an automated digital IFA microscope, a long-awaited solution for laboratories performing ANCA IFA testing.