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FDA Clears Inova Dx Kits

NEW YORK (360Dx) – The US Food and Drug Administration this week cleared Inova Diagnostics' Nova Lite DAPI ANCA (ethanol) and Nova Lite DAPI ANCA (formalin) kits for use with the the firm's Nova View immunofluorescence assay microscope, Inova Dx said.

The Nova Lite Dapi Anca kits are the first reagents cleared by the FDA for detecting antineutrophil cytoplasmic antibodies on an automated digital IFA microscope, Inova added.

Currently IFA testing is time- and labor-intensive with a manual workflow that may be prone to transcription errors. Nova View addresses these obstacles by reducing hands-on time, providing consistent reading and interpretation conditions, and generating digital images that can be archived.

Antineutrophil cytoplasmic antibodies are a group of antibodies associated with diseases such as granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis. Because they vary in their clinical presentation and have the potential for severe outcomes, including kidney impairment, early diagnosis is crucial, Inova Dx said.

"These kits represent a breakthrough that fundamentally changes the way ANCA IFA is performed in diagnostic laboratories, and will bring efficiency and reliability to this traditionally labor-intensive and subjective field of diagnostic immunology," said Michael Mahler, vice president of R&D for Inova Dx.