New Assays for Screening and Diagnosing ANCA-Associated Vasculitis Receives FDA Clearance

PerkinElmer, Inc., a global leader committed to innovating for a healthier world, has announced that its EUROIMMUN ANCA IFA and EUROPLUS Granulocyte Mosaic™ assay, for use with EUROPattern microscope, have received 510(k) clearance from the U.S. Food & Drug Administration (FDA).

The EUROIMMUN IFA Granulocyte, commonly referred to as ANCA Mosaic, assays are designed as indirect immunofluorescence tests for the qualitative or semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of immunoglobulin class IgG in human serum. The EUROPLUS Granulocyte Mosaic EUROPattern assay allows for additional monospecific detection of anti-PR3, anti-MPO andanti-GBM IgG antibodies.

These IFA mosaics, together with the FDA-cleared EUROPattern microscope, are used to aid in the diagnosis of ANCA-associated vasculitis (AAV), which affects 42 out of 100,000 people in the U.S.¹ Known forms of AAV include: granulomatosis with polyangiitis (GPA), Microscopic Polyangiitis (MPA) and Eosinophilic granulomatosis with polyangiitis (EGPA).

In addition, about a third of anti-glomerular basement membrane (GBM) disease patients are ANCA positive; parallel testing for ANCA and anti-GBM is recommended upon renal involvement. Broad initial symptoms—in combination with high mortality and long-term morbidity often associated with these vasculitides—demand effective diagnostic tools to help confirm the disease state.

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“Vasculitis disorders are often difficult to diagnose, as symptoms can vary greatly among patients, depending on the organs or systems affected. To identify and implement the most effective treatment, it’s imperative to make a diagnosis quickly and confidently,” said Prahlad Singh, Executive Vice President and President, Diagnostics, PerkinElmer.

“Thanks to the multiplexing capability of the EUROIMMUN IFA Granulocyte Mosaic and EUROPLUS Granulocyte Mosaic assays, a single well provides a complete and reliable ANCA screening result, eliminating the need to run several analyses per sample, as the well can contain up to 6 biochips. This can minimize the risk of error and greatly benefit patients who are suffering from these disorders.”

EUROIMMUN’s proprietary BIOCHIP™ technology offers the unique ability to provide differentiation of cANCA and pANCA, detection of any co-existing ANA and monospecific confirmation via EUROPLUS antigen dots (PR3, MPO and GBM)—all in the same well. The fully automated EUROPattern system for computer-aided immunofluorescence microscopy allows for faster processing by acquisition of digital images within 13 seconds per image and subsequent automated classification/evaluation of results.

Following the successful FDA clearance of anti-nuclear antibody (ANA) IFA on HEp-cells, Crithidia luciliae (anti-dsDNA) and Crithidia luciliae sensitive (anti-dsDNA) IFA, the granulocyte IFA mosaics for the detection of ANCA are the most recent assays to receive FDA clearance for use with the EUROPattern Suite. This enhanced menu further expands the range of EUROIMMUN products available for fully automated imaging and evaluation with EUROPattern.

EUROIMMUN, a PerkinElmer company, is widely recognized as a global leader in autoimmune testing and an emerging force in infectious disease and allergy testing. It has extensive expertise and capabilities across immunology, cell biology, histology, biochemistry and molecular biology.

^[1] Alvise Berti DC, Cynthia S. Crowson, Ulrich Specks and Eric L. Matteson. The Epidemiology of ANCA Associated Vasculitis in the U.S.: A 20 Year Population Based Study. Abstract 2017 ACR/ARHP Annual Meeting (2017)