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February 6, 2017
San Diego, CA, US – 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.
Anti-neutrophil cytoplasmic antibodies (ANCA) are a group of autoantibodies associated with diseases such as granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). This group of related diseases varies considerably in their clinical presentation, and has the potential for severe outcomes, including renal impairment. Early diagnosis is crucial.
IFA testing, as it is currently practiced in many laboratories, is time and labor-intensive, subject to interpretation bias. The workflow is manual, and prone to transcription errors. NOVA View addresses many shortcomings of manual IFA processing by reducing hands-on time, providing consistent reading and interpretation conditions, and generating digital images that can be archived. It allows for full patient sample traceability and improves assay integrity by using NOVA Lite barcoded IFA slides.
“I am truly excited about the approval of NOVA Lite ANCA DAPI Kits”, commented Laurel Tria, Technical Director Automated Laboratory, Northwell Laboratories. “It marks a significant step forward in automating and standardizing the ANCA IFA test while providing clinicians with a highly reliable test result. In addition, the capability of providing an ANCA IFA test result that can be seamlessly uploaded into the patient’s electronic medical record will be a remarkable step forward in prompt and accurate reporting.”
“Inova Diagnostics is pleased to launch these newly FDA cleared ANCA assays, expanding the number of assays available on NOVA View to three”, said Michael Mahler, PhD, Vice President, Research and Development of Inova Diagnostics. “Inova Diagnostics has a 28 year history of providing laboratories with innovative products required for autoimmune diagnosis. NOVA Lite DAPI ANCA (Ethanol) and NOVA Lite DAPI ANCA (Formalin) Kits continue this tradition. 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.”
NOVA View automates the interpretation and reporting of IFA Antinuclear Antibody (ANA) and ANCA testing. NOVA View automatically acquires, interprets, presents and archives digital IFA images for operator review and confirmation. It determines the result (positive or negative), and performs pattern interpretation. After result and pattern confirmation by the operator, NOVA View is able to predict a pattern specific endpoint titer. Results are recorded electronically in a transcription free and paperless work environment, and all digital images are archived for future review.
Inova Diagnostics is a privately held company headquartered in San Diego, California, and is a part of WerfenLife, a global leader in IVD with a long term commitment to providing high quality, innovative solutions for hospitals and clinical laboratories to enhance patient care. Inova Diagnostics manufactures IVD systems and reagents for autoimmune disease that are used in clinical laboratories and hospitals around the world, and is a leader in the development and commercialization of new autoimmune technologies and diagnostic markers. NOVA View and NOVA Lite are registered trademarks of Inova Diagnostics. Further information about Inova Diagnostics can be found at www.inovadx.com.