Werfen Expands Automated APS Testing with FDA-Cleared and CE-Marked IgA Reagent

Comprehensive antibody profiling across relevant immunoglobulin classes can help laboratories support a more complete evaluation. A newly cleared reagent now completes a full antiphospholipid antibody isotype panel on an automated platform in the U.S. and Europe.

Werfen’s Aptiva Antiphospholipid Syndrome Immunoglobulin A (IgA) Reagent has received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR). With these regulatory authorizations, the Aptiva APS testing portfolio now covers all three major isotypes—IgA, IgG, and IgM—for both anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) antibodies. By completing the available isotype panel, the new reagent is intended to broaden access to more comprehensive APS testing on the Aptiva system.

The Aptiva APS IgA Reagent uses particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of aCL and aβ2GP1 IgA antibodies in human serum. When used alongside the Aptiva APS IgG and IgM reagents and interpreted together with other laboratory and clinical findings, the IgA assay provides additional diagnostic information that may aid in the evaluation of primary and secondary APS. Together, the three isotypes provide a more complete APS antibody profile to support clinical assessment and patient management.

Aptiva is a fully automated, next-generation multi-analyte system designed to streamline autoimmune testing by processing multiple analytes simultaneously from a single patient sample. Powered by PMAT, the platform supports high-throughput testing with minimal hands-on time while consolidating serologic information within a single workflow. In addition to APS testing, the Aptiva assay menu includes tests for celiac disease and connective tissue diseases.

“Completing the APS isotype panel with the addition of IgA significantly enhances the clinical value of the Aptiva system. APS can present with nonspecific or overlapping symptoms, making diagnosis challenging. By offering all three isotypes, clinicians and laboratories can obtain a more comprehensive assessment that supports informed clinical decision-making and improved patient care,” said Anthony Prestigiacomo, vice president of research and development at Werfen.

“As the Aptiva menu continues to expand, with additional key biomarkers in development, we are building a platform that advances laboratory efficiency while delivering deeper clinical insight. The FDA clearance and CE Mark for APS IgA represent important milestones in our commitment to expanding access to innovative autoimmune diagnostics worldwide,” said Vijay Namasivayam, Ph.D., chief operating officer at Werfen.