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FDA Clears PerkinElmer Antibody Detection Assays

NEW YORK (360Dx) – PerkinElmer announced late Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for two assays developed by its Euroimmun subsidiary for the screening and diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA)- associated vasculitis.

The Euroimmun ANCA IFA assay is designed as an indirect immunofluorescence test for the qualitative or semi-quantitative determination of ANCA of immunoglobulin class IgG in human serum, PerkinElmer said. The EuroPlus Granulocyte Mosaic assays for use with the EuroPattern microscope, which is also FDA-cleared, allows for additional monospecific detection of anti-PR3, anti-MPO, and anti-GBM IgG antibodies.

ANCA-associated vasculitis (AAV) affects 42 out of 100,000 people in the US, and its known forms include granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). Further, the company noted, about a third of anti-glomerular basement membrane (GBM) disease patients are ANCA positive, and parallel testing for ANCA and anti-GBM is recommended upon renal involvement.

Euroimmun's Biochip technology has the ability to differentiate between cytoplasmic ANCAs and perinuclear ANCAs, detect any co-existing antinuclear antibodies, and conduct monospecific confirmation via EuroPlus antigen dots (PR3, MPO and GBM), all in the same well. The fully automated EuroPattern system for computer-aided immunofluorescent microscopy allows for faster processing by acquisition of digital images within 13 seconds per image and subsequent automated classification and evaluation of results, according to PerkinElmer.

"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," Prahlad Singh, executive vice president and president of PerkinElmer's diagnostics unit, said in a statement. "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 six biochips. This can minimize the risk of error and greatly benefit patients who are suffering from these disorders."

PerkinElmer acquired Euroimmun last year for $1.3 billion. The deal was completed in December.