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Werfen Granted CE Mark for Aptiva® Reagents Designed for Antiphospholipid Syndrome Testing

Monday, February 19, 2024

Werfen has recently announced the attainment of the CE (Conformité Européenne) mark for its Aptiva® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents, complying with the European Union's (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR). These reagents employ Aptiva particle-based multi-analyte technology (PMAT) to semi-quantitatively determine anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma. They serve as diagnostic aids for primary and secondary APS, assisting clinicians in distinguishing it from other conditions with similar symptoms.

Antiphospholipid syndrome poses diagnostic challenges due to its diverse clinical presentations, including venous or arterial thrombosis and fetal loss. Timely detection is vital for preventing complications and reducing healthcare costs associated with unnecessary procedures.

The Aptiva APS reagents complement Werfen's existing Aptiva Celiac Disease and Connective Tissue Diseases (CTD) Essential reagents, broadening the range of CE Marked analytes detected by Aptiva to 19. Werfen is dedicated to developing assays for various autoimmune disease states, with over 60 analytes in advanced development stages, promising advancements in autoimmune disease diagnosis and patient management.

The Aptiva system represents the next generation of high throughput analyzers for autoimmunity and immunology laboratories. Its fully automated multi-analyte platform, utilizing PMAT technology, can deliver up to 120 APS results per hour, streamlining laboratory workflows, reducing hands-on time, and enhancing operational efficiency.


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