Original from: Werfen
Werfen today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aptiva® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents.
The Aptiva APS IgG and APS IgM Reagents are immunoassays that utilize Aptiva’s particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM in human serum. These assays aid in diagnosing both primary and secondary APS, when used in conjunction with other laboratory and clinical findings.
"Antiphospholipid syndrome presents significant diagnostic challenges due to its complex symptomatology, often resembling other conditions," said Michael Mahler, PhD, Senior Vice President of Research and Development at Werfen.
"The FDA clearance of the Aptiva APS IgG and APS IgM Reagents marks a crucial step forward in our mission to enhance diagnostic accuracy for autoimmune diseases. These Reagents provide comprehensive data that empower healthcare professionals to make informed decisions, ultimately improving patient outcomes and reducing the burden of misdiagnosis."
The Aptiva system, a next-generation fully automated multi-analyte system, represents a significant advancement for autoimmune laboratories. By utilizing PMAT, Aptiva can deliver up to 960 results in an 8-hour shift for APS testing, allowing laboratories to handle high volumes efficiently with minimal hands-on intervention.
These new APS Reagents expand Werfen’s robust Aptiva portfolio, which includes the Celiac Disease and Connective Tissue Diseases (CTD) Essential Reagents. This latest clearance expands the Aptiva portfolio to 18 FDA-cleared analytes.
Looking ahead, Werfen is in development to expand the Aptiva portfolio further to address additional autoimmune disease states, with over 60 analytes currently in various development stages. These efforts aim to improve the accuracy of autoimmune disease diagnoses and support more effective patient management strategies.
Source: Werfen Receives US FDA 510(k) Clearance for Aptiva® Antiphospholipid Syndrome Reagents
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