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PerkinElmers EUROIMMUN Receives 510(k) Clearance for Crithidia luciliae and Crithidia luciliae Sensitive Diagnostic Tests

PerkinElmer,
Inc., a global leader committed to innovating for a healthier world,
today announced that its EUROIMMUN
Crithidia luciliae immunofluorescence test (CLIFT) and CLIFT
sensitive assays have received FDA 510(k) clearance.

CLIFT testing is critical in supporting the detection of anti-double
stranded DNA (anti-dsDNA)—one of the exclusive markers for systemic
lupus erythematosus (SLE), a severe rheumatic autoimmune disease
commonly known as lupus. The prevalence of anti-dsDNA ranges from 40 to
90 percent in lupus patients with exceptional specificity.1

While other immunological tests, including ELISA and RIA, routinely
detect anti-dsDNA antibodies, these methods historically only provide
sensitivities around 20 percent. The EUROIMMUN CLIFT sensitive
assay—performed on the fully-automated EUROPattern
microscope and software system—improves sensitivity by 30 percent
versus other serological tests, helping minimize false negative results.2
Specificity is maintained simultaneously, helping clinical labs to avoid
false positive results, thus enabling rheumatologists or primary care
physicians to diagnose lupus with greater confidence.

The EUROPattern microscope’s fully-automated workflow, which renders
digital images within 13 seconds per field, allows the EUROIMMUN CLIFT
assays to improve result turnaround time during the screening process.
EUROIMMUN’s proprietary BIOCHIP™ technology further enhances efficiency
and cost savings by requiring less sample and reagents.

“Correct diagnosis is a prerequisite to determining effective
treatment,” said Prahlad Singh, Executive Vice President and President,
Diagnostics, PerkinElmer. “The FDA’s clearance of the EUROIMMUN CLIFT
assays represents a significant milestone in helping clinicians more
quickly and accurately detect autoimmune disorders and provide
personalized care for those with lupus.”

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 PerkinElmerPerkinElmer, 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 www.perkinelmer.com.

1 Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R,
Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, et al. Estimates of
the prevalence of arthritis and other rheumatic conditions in the United
States. Part I. Arthritis Rheum 58 (2008) 15-25.2
Gerlach S, Affeldt K, Pototzki L, Krause C, Voigt J, Fraune J, and
Fechner K. Automated Evaluation of Crithidia luciliae Based Indirect
Immunofluorescence Tests: A Novel Application of the EUROPattern-Suite
Technology. J. Immunol Res 2015 (2015) 742402.

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