The regulatory approvals complete the company’s antiphospholipid syndrome testing portfolio for IgA, IgG, and IgM on its automated multi-analyte platform.
Werfen announced that its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin A (IgA) Reagent has received US Food and Drug Administration (FDA) 510(k) clearance and the CE mark under the European Union In Vitro Diagnostic Medical Devices Regulation.
The regulatory clearances finalize the Aptiva APS assay portfolio, which now includes all three APS isotypes—IgA, IgG, and IgM—for both anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ₂GP1) antibodies. The addition expands diagnostic options on the Aptiva platform, which also supports testing menus for celiac disease and connective tissue diseases.
Expanding Autoimmune Isotype Profiling
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. Designed to run alongside Aptiva APS IgG and IgM assays, the test provides supplemental diagnostic data to support clinicians in evaluating both primary and secondary APS in conjunction with other laboratory and clinical findings.
APS is an autoimmune condition characterized by thrombotic events and pregnancy complications. Because clinical features frequently mimic or overlap with other autoimmune and vascular disorders, full antibody profiling can help differentiate the condition and guide patient management.
“Completing the APS isotype panel with the addition of IgA significantly enhances the clinical value of the Aptiva system,” says Anthony Prestigiacomo, vice president of research and development at Werfen, in a release. “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.”
Multi-Analyte Testing Workflow
Aptiva is a fully automated multi-analyte system designed to streamline autoimmune diagnostic workflows. Using PMAT, the instrument tests multiple analytes simultaneously from a single patient sample, helping laboratories reduce hands-on preparation time while delivering high throughput.
“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,” says Vijay Namasivayam, PhD, chief operating officer at Werfen, in a release. “The FDA clearance and CE Mark for APS IgA represent important milestones in our commitment to expanding access to innovative autoimmune diagnostics worldwide.”
Photo caption: Aptiva Antiphospholipid Syndrome Immunoglobulin A Reagent
Photo credit: Werfen
