San Diego – September 23, 2026 -- Werfen has secured U.S. FDA 510(k) clearance and a CE Mark under the EU's IVDR for its Aptiva Antiphospholipid Syndrome (APS) IgA Reagent, completing a three-isotype APS testing portfolio on its Aptiva platform.
Aptiva now covers all three APS antibody isotypes for global laboratories
The clearance means Aptiva offers IgA, IgG, and IgM testing for both anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) antibodies, giving laboratories a full antibody profile for antiphospholipid syndrome, an autoimmune disease linked to thrombotic events and pregnancy complications that is often difficult to diagnose due to overlapping clinical symptoms.
New IgA reagent uses particle-based multi-analyte technology for semi-quantitative results
The Aptiva APS IgA Reagent applies Werfen's particle-based multi-analyte technology (PMAT) to semi-quantitatively detect aCL and aβ2GP1 IgA antibodies in human serum. Used alongside the existing IgG and IgM reagents, the assay adds diagnostic data to support clinicians evaluating both primary and secondary APS in conjunction with other clinical findings.
Executives frame the launch as a milestone for autoimmune diagnostics expansion
"Completing the APS isotype panel with the addition of IgA significantly enhances the clinical value of the Aptiva system," said Anthony Prestigiacomo, Vice President of Research and Development at Werfen, noting that offering all three isotypes supports more informed clinical decision-making.
Vijay Namasivayam, PhD, Chief Operating Officer at Werfen, said the FDA clearance and CE Mark for APS IgA mark important milestones as the company expands its Aptiva menu with additional biomarkers in development.
Aptiva portfolio expansion follows prior additions in Celiac and connective tissue disease testing
The APS IgA clearance builds on Aptiva's existing assay menu, which includes Celiac Disease and Connective Tissue Diseases (CTD) testing, positioning the fully automated, single-sample multi-analyte system as a consolidated solution for autoimmune disease laboratories worldwide.