Therapy Areas: Autoimmune
Werfen receives CE mark for Aptiva Antiphospholipid Syndrome Immunoglobin G and Immunoglobulin M reagents
20 February 2024 -

Werfen, a Spain-based company that develops, manufactures and distributes specialised diagnostic instruments, related reagents, automation workcells, and data management solutions for use mainly in hospitals and independent clinical laboratories, announced on Monday that it has received the CE (Conformite Europeenne) 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 use Aptiva particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (a beta 2GP1) IgG and IgM autoantibodies in human serum and citrated plasma. The products are utilised to support in the diagnosis of primary and secondary APS, when used in conjunction with with other laboratory findings.

Michael Mahler, PhD, vice president of Research and Development at Werfen, said, '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. 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.'