Market Overview

PerkinElmer's EUROIMMUN Receives FDA Clearance for ANCA IFA and EUROPLUS Granulocyte Mosaic™ Assays Using EUROPattern Microscope


Assist in Screening and Diagnosing ANCA-Associated Vasculitis

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

The EUROIMMUN IFA Granulocyte assays, commonly referred to as ANCA
Mosaic™, 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 and anti-GBM IgG

These IFA Mosaic™ assays, 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.

"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 immunofluorescent 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 mosaicMosaic ™ assays
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.

About PerkinElmer

PerkinElmer, Inc. is a global leader committed to innovating for a
healthier world. Our dedicated team of about 11,000 employees worldwide
is passionate about providing customers with an unmatched experience as
they help solve critical issues especially impacting the diagnostics,
discovery and analytical solutions markets. Our innovative detection,
imaging, informatics and service capabilities, combined with deep market
knowledge and expertise, help customers gain earlier and more accurate
insights to improve lives and the world around us. The Company reported
revenue of approximately $2.3 billion in 2017, serves customers in more
than 150 countries, and is a component of the S&P 500 Index. Additional
information is available through 1-877-PKI-NYSE, or at

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).

View Comments and Join the Discussion!