Inova Diagnostics gains FDA de novo clearance for NOVA View automated digital IFA microscope

Apr 12 2015

Inova Diagnostics, the worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, announced today that the United States Food and Drug Administration (FDA) has cleared NOVA View, an automated digital IFA (indirect fluorescent assay) microscope, through the de novo classification process. NOVA View is the first FDA cleared automated digital IFA microscope in the USA, a long-awaited solution for laboratories that perform IFA for the detection of antinuclear antibodies (ANA). NOVA Lite^® DAPI ANA Kit, an IFA reagent indicated for use with NOVA View, received 510(k) clearance at the same time.

ANA is the first line laboratory test for the diagnosis of systemic lupus erythematosus and other systemic autoimmune rheumatic diseases. Early and accurate diagnosis and effective treatment are key to reducing the morbidity associated with these conditions.

IFA is the gold standard for ANA testing according to a Position Statement issued by the American College of Rheumatology in 2009. IFA, as it is currently practiced in many laboratories, is time and labor-intensive, subject to interpretation bias and other variables, such as the type of microscope and intensity of the light source. The workflow is manual, and prone to transcription errors.

NOVA View addresses many shortcomings of the manual IFA process by reducing hands-on time, providing consistent reading and interpretation conditions, and generating digital images that can be archived. It provides patient sample traceability with positive patient identification and improves assay integrity by using NOVA Lite barcoded IFA slides.

"I am truly excited about the clearance of NOVA View," commented Marvin Fritzler, PhD, MD, Professor Cumming School of Medicine, University of Calgary and Director of Mitogen Advanced Diagnostics. "It is the fruition of a long anticipated technology breakthrough, marking a significant step forward in standardizing the ANA IFA test and providing clinicians with a reliable test result. In addition, the capability of providing an IFA test result that can be seamlessly uploaded into the patient's electronic medical record will be a remarkable advancement in prompt and accurate reporting."

"Inova Diagnostics is pleased to launch the first automated digital IFA microscope in the US," said Roger Ingles, Chief Executive Officer of Inova Diagnostics. "Inova Diagnostics has a 28 year history of providing laboratories with innovative products required for autoimmune diagnosis. NOVA View continues this tradition."

"NOVA View is a technology that fundamentally changes the way IFA is performed in diagnostic laboratories," said Gabriella Lakos, MD, PhD, Director of Assay Development. "NOVA View will bring efficiency and reliability to this traditionally labor intensive and subjective area of diagnostic immunology."