Werfen Wins FDA Clearance, CE Mark for Aptiva APS IgA Assay
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.