Fully automated IFA evaluation system EUROPattern receives FDA 510(k) Clearance

EUROIMMUN Creates a Paradigm Shift in ANA Testing through the FDA clearance of its EUROPattern Computer Aided Immunofluorescent Microscope.
 
MORRIS PLAINS, N.J. - April 23, 2015 - PRLog -- Morris Plains, New Jersey April 17, 2015

EUROIMMUN US, Inc.
announced the FDA 510(k) clearance of their EUROPattern system (EUROIMMUN IFA 40: HEp-20-10 EUROPattern Microscope and Software System).  As one of the market leaders in autoimmune diagnostics, this represents yet another milestone for EUROIMMUN in our global strategy to deliver innovative diagnostic products and automation solutions for laboratories worldwide.

“The FDA clearance of the EUROPattern system represents an enormous progress for the modern ANA laboratory”, said Hamid Erfanian, Chief Executive Officer of EUROIMMUN US, Inc. “EUROIMMUN is by far the greatest autoimmunity expert worldwide, well-known for its sophisticated test systems and automated solutions. The EUROPattern system is no exception in this regard.”

The EUROPattern system is an automated fluorescent microscope (oculars included for manual interpretation) and software that acquires, interprets,archives and displays digital images of stained IFA slides. The most important application for EUROPattern is the ANA screening using HEp-20-10 cells (EUROIMMUN IFA 40: HEp-20-10 EUROPattern). HEp-20-10 cells are an additional proprietary innovation of EUROIMMUN as they demonstrate 10-fold more mitotic cells than traditional HEp-2 cells. Furthermore, they contain the full antigen spectrum necessary for ANA diagnostics and are thus ideally suited for this purpose.

EUROIMMUN, being at the forefront of innovations in autoimmunity for more than 25 years, redefines the IFA workflow and improves efficiencies in the laboratory with the user-friendly EUROPattern system. This solution addresses many of the limitations of the manual IFA process by:

·       Providing automated pattern recognition and end-point titer suggestions and consequently reducing interpretation bias

·       Offering a true walkaway capability and maximizing throughput for ANA evaluation via the automated processing of up to 500 fields/50 barcoded slides per run

·       Reducing turnaround time by allowing for batch validations of negative results and by dramatically abbreviating the evaluation process through consolidation of all pattern and titer results for each patient on one screen

·       Complete Sample Traceability for Patient Safety - Barcoded slide identification with bi-directional LIS interface.  (EUROLabOffice is the embedded software that allows the instrument to communicate seamlessly with the LIS and offers the ability to send results and images to any connected computer)

·       Classification of anti-nuclear antibody (ANA) and anti-cytoplasmic antibody patterns, including the interpretation of mixed patterns and titers

“EUROPattern, along with the Sprinter IFA slide processor, has already been placed in nearly one hundred laboratories worldwide,” states Dr. Wolfgang Schlumberger, PhD, Vice Chairman of the Executive Board of EURO­IMMUN AG. “This system provides a fully-automated solution allowing laboratories to perform testing on hundreds of samples per day. With the FDA clearance of the EUROPattern system, customers can now enjoy the benefits of standardization of pattern recognitionand optimize workflow efficiencies in laboratories across the U.S.”

EUROIMMUN is one of the leading manufacturers of medical laboratory diagnostics worldwide and stands for innovation and develops, manufactures, and markets test systems for the diagnosis of autoimmune and infectious diseases, and software and automation solutions for the performance and evaluation of these assays. Laboratories in over 150 countries use EUROIMMUN products for the diagnosis of autoimmune, infectious diseases and allergies.  EUROIMMUN commands a broad technology base which has enabled it to initiate and promote fundamental, new developments in medical laboratory diagnostics. Examples include the molecular biological synthesis of designer antigens, computer aided immunofluorescence microscopy (CAIFM) and the development of multi-parametric microarrays for the identification of genetic polymorphisms, tumors or pathogenic agents, amongst others.

For more information, please contact EUROIMMUN’s Marketing Manager, Richard Peluso at (973) 656-1000, r.peluso@euroimmun.us  www.euroimmunus.com

END

Contact
Richard Peluso
r.peluso@euroimmun.us
9736561000
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Tags:Autoimmunity, Ana, Laboratory, Infectious Disease, Lab Testing
Industry:Biotech, Medical
Location:Morris Plains - New Jersey - United States
Subject:Products
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