Werfen Secures FDA and CE Clearance for Aptiva APS IgA Test
Werfen has received US Food and Drug Administration (FDA) 510(k) clearance and CE Mark under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) for its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin A (IgA) Reagent.
The regulatory milestones complete the Aptiva APS testing portfolio, which now includes IgA, IgG and IgM testing for anti-cardiolipin and anti-beta 2 glycoprotein 1 antibodies.
The expanded portfolio is intended to provide laboratories with a broader antibody profile to support the evaluation of primary and secondary APS alongside clinical findings and other laboratory results.
The Aptiva APS IgA Reagent uses Werfen’s particle-based multi-analyte technology (PMAT) for the semi-quantitative detection of IgA antibodies in human serum.
APS is an autoimmune disorder associated with blood clots and pregnancy-related complications, and its symptoms can overlap with other conditions, making diagnosis challenging.
Aptiva is a fully automated multi-analyte system designed to process multiple biomarkers from a single patient sample.
The platform aims to streamline autoimmune testing workflows while reducing hands-on laboratory time.
The APS IgA addition complements Aptiva’s existing autoimmune testing menu, including assays for coeliac disease and connective tissue diseases.
The new regulatory clearances expand access to the complete APS testing panel in the US and Europe.
