PerkinElmer’s EUROIMMUN Receives 510(k) Clearance for Crithidia luciliae and Crithidia luciliae Sensitive Diagnostic Tests
June 18, 2018 at 08:15 am EDT
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PerkinElmer, Inc. announced that its EUROIMMUNCrithidia 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% in lupus patients with exceptional specificity. 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 EUROPatternmicroscope and software system—improves sensitivity by 30% versus other serological tests, helping minimize false negative results. 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 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.
Revvity, Inc. (formerly PerkinElmer, Inc.) specializes in designing, manufacturing, and marketing measurement devices and analytical instruments for the healthcare, environmental, scientific research, industry and food sectors. Net sales (including intragroup) break down by family of products as follows:
- medical diagnosis equipment (61%);
- analytical tools and instruments (39%): biological molecular research tools, thermal analysis software, chemical and environmental measurement tools, genetic screening instruments, reagents, etc.
Net sales are distributed geographically as follows: the United States (46.7%), China (14.4%), the United Kingdom (4.1%) and other (34.8%).