Inova Diagnostics receives FDA 510(k) clearance for ANCA IFA assays

6 February 2017 (Last Updated February 6th, 2017 18:30)

Inova Diagnostics has received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of its NOVA Lite kits with the NOVA View Immunofluorescence Assay (IFA) microscope.

Inova Diagnostics receives FDA 510(k) clearance for ANCA IFA assays

Inova Diagnostics has received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of its NOVA Lite kits with the NOVA View Immunofluorescence Assay (IFA) microscope.

The kits include NOVA Lite DAPI ANCA Ethanol and Formalin reagents for the anti-neutrophil cytoplasmic antibodies (ANCA) identification on an automated digital IFA microscope.

The detection of ANCA autoantibodies is helfpful for the early diagnosis of associated diseases such as granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA).

Inova Diagnostics research and development vice-president Michael Mahler said: "Inova Diagnostics is pleased to launch these newly FDA cleared ANCA assays, expanding the number of assays available on NOVA View to three.

"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 will bring efficiency and reliability to this traditionally labor intensive and subjective field of diagnostic immunology."

"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."

It is expected that the provision for uploading an ANCA IFA test result into the patient's electronic medical record will enable precise reporting.

The NOVA View is designed to automatically acquire, interpret, present and store digital images during IFA Antinuclear Antibody (ANA) and ANCA testing as well as determine the result along with pattern interpretation.


Image: NOVA View(R) automated digital IFA microscope for NOVA Lite(R) DAPI ANCA (Ethanol), NOVA Lite(R) DAPI ANCA (Formalin), and NOVA Lite(R) DAPI Hep-2. Photo: courtesy of PRNewsFoto/Inova Diagnostics.