STATEMENT: Werfen receives CE mark for Aptiva® antiphospholipid syndrome reagents

(Information sent by the signatory company).

STATEMENT: Werfen receives CE mark for Aptiva® antiphospholipid syndrome reagents

(Information sent by the signatory company)

New Aptiva APS IgG and APS IgM reagents enable early diagnosis of antiphospholipid syndrome in difficult-to-diagnose autoimmune diseases

SAN DIEGO, February 19, 2024/PRNewswire/ -- Werfen today announced that it has received the CE (Conformité Européenne) mark for its Aptiva® Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents for Antiphospholipid Syndrome (APS) according to the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR).

Aptiva APS IgG and APS IgM reagents are immunoassays utilizing Aptiva's particle-based multianalyte technology (PMAT) for the semiquantitative 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 to 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 difficult to diagnose because its symptoms can mimic those of other diseases," said Michael Mahler, PhD, vice president of Research and Werfen development.

"Early diagnosis is crucial to prevent complications, as well as unnecessary procedures and increased healthcare costs. Aptiva APS IgG and APS IgM offer expanded information to physicians to assist with the diagnosis and treatment of patients with autoimmune diseases."

The new Aptiva APS reagents complement Werfen's previously registered Aptiva essential reagents for celiac disease and connective tissue diseases (CTD) and expand the number of CE-marked analytes detected by Aptiva to 19.

In addition to APS, CTD and celiac disease trials, Aptiva will focus on additional autoimmune disease states and has more than 60 analytes in various stages of advanced development. These analytes have the potential to improve the accuracy of diagnosis of autoimmune diseases 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 results up to 120 APS per hour. With PMAT, Aptiva enables the laboratory to complete its workload faster and with minimal hands-on time.

About Werfen

Werfen (, founded in 1966, is a global developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation work cells and data management solutions for use primarily in hospitals and independent clinical laboratories. The company's business lines include autoimmunity, hemostasis, critical care diagnostics, transfusion, transplantation and original equipment manufacturing (OEM).

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

The Werfen logo is a registered 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 a 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 other jurisdictions. All other product names, company names, brands, logos and symbols are the trademarks of their respective owners.

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