Summary: Werfen’s Aptiva APS IgG and IgM Reagents, powered by PMAT technology, receive FDA clearance to improve the diagnosis of antiphospholipid syndrome (APS), addressing a critical need in autoimmune disease diagnostics.

Takeaways:

  1. Innovative Diagnostics: The Aptiva APS IgG and IgM Reagents use advanced particle-based multi-analyte technology (PMAT) to semi-quantitatively detect anti-cardiolipin and anti-beta 2 glycoprotein 1 antibodies in human serum.
  2. Enhanced Efficiency: Aptiva’s fully automated system delivers up to 960 test results in an eight-hour shift, enabling high-throughput testing with minimal manual intervention.
  3. Portfolio Expansion: With this clearance, Werfen’s Aptiva portfolio grows to 18 FDA-cleared analytes, with over 60 additional analytes in development to further advance autoimmune disease diagnostics.

Werfen announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents.

Aptiva Antiphospholipid Syndrome 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,” says Michael Mahler, PhD, senior VP 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 for Autoimmune Laboratories

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 eight-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. 

Further Reading

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Looking ahead, Werfen says it 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.

Featured image: Aptiva utilizes particle-based multi-analyte technology (PMAT). Photo: Werfen