Werfen Receives CE Mark for Aptiva® Antiphospholipid Syndrome Reagents

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New Aptiva APS IgG and APS IgM Reagents Enable Early Diagnosis of Antiphospholipid Syndrome in Hard-to-Diagnose Autoimmune Disease

SAN DIEGO, Feb. 19, 2024 /PRNewswire/ -- Werfen today announced it has received CE (Conformité Européenne) mark for its Aptiva^® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents under the European Union's (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR).  

The Aptiva APS IgG and APS IgM reagents are immunoassays that utilize Aptiva particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma. They are used as an aid in the diagnosis of primary and secondary APS, when used in conjunction with other laboratory findings.

"Antiphospholipid syndrome is an autoimmune disease that manifests clinically as venous or arterial thrombosis and/or fetal loss and can be challenging to diagnose as its symptoms can mimic those of other conditions," said Michael Mahler, PhD, Vice President of Research and Development at Werfen. 

"Early diagnosis is crucial in preventing complications as well as unnecessary procedures and increased healthcare costs. Aptiva APS IgG and APS IgM deliver expanded information to clinicians to help with the diagnosis and management of patients with autoimmune diseases."

The new Aptiva APS reagents complement Werfen's previously registered Aptiva Celiac Disease and Connective Tissue Diseases (CTD) Essential reagents and expand the number of CE Marked analytes detected by Aptiva to 19.

In addition to the APS, CTD and Celiac Disease assays, Aptiva will target additional autoimmune disease states, and has over 60 analytes in various stages of advanced development. These analytes have the potential to improve the accuracy of autoimmune disease diagnosis and support better patient management.

The Aptiva system is a fully automated multi-analyte system that represents the next generation of high throughput analyzers for the autoimmunity and immunology laboratory.  

Aptiva uses particle-based multi-analyte technology to deliver up to 120 APS results per hour. With PMAT, Aptiva enables the laboratory to complete its workload faster and with minimal hands-on time.

About Werfen

Werfen (werfen.com) founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Autoimmunity, Hemostasis, Acute Care Diagnostics, Transfusion, Transplant, and Original Equipment Manufacturing (OEM).

Werfen's solutions help improve the way patients with autoimmune diseases are diagnosed, monitored, and treated. The autoimmunity portfolio includes Aptiva^®, BIO-FLASH^®, NOVA View^®, and QUANTA-Lyser^® 3000 systems, and QUANTA Link^® data management solution.

The Werfen logo is a trademark of Werfen. Aptiva, QUANTA-Lyser, QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite are registered trademarks of Inova Diagnostics, Inc., a Werfen company, as the legal manufacturer. BIO-FLASH is a registered trademark of Biokit S.A. GEM, Premier, GEM Premier ChemSTAT, GEMweb, iQM, ChemSTAT, HemosIL, ACL, ACL TOP, ACL Elite, ACL AcuStar, ReadiPlasTin, RecombiPlasTin, SynthASil, SynthAFax, ROTEM, Hemochron, VerifyNow and Avoximeter are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.  

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