Autoimmune Disease Diagnostics: Test Development, Control & Standardization
Autoimmune Disease Diagnostics: Test Development, Control & Standardization
Wednesday, September 30th | 11am EST , 5pm CST
Webinar followed by a live Q&A
Autoimmune diagnostics sit at the intersection of complex biology, evolving biomarkers and demanding regulatory expectations, making robust assay design and standardization essential for reliable patient care.
In this second webinar, BBI and Dr. Michael Mahler will discuss a practical framework for autoimmune IVD assay development, from biomarker selection and analytical design through to regulatory requirements and commercialization. We will review the pitfalls that can compromise assay performance, and strategies to address through reagent selection and standardization. The session will examine commercial and regulatory pathways to bring autoimmune IVDs to market, and discuss the role of proficiency testing, harmonization initiatives and post‑market quality assurance as critical tools to sustain diagnostic assay reliability over time.
This webinar is designed for assay developers, IVD manufacturers and laboratory leaders involved in bringing autoimmune diagnostics from concept to routine clinical use.
About Our Speaker
Dr. Michael Mahler - Autoimmunity and diagnostic immunology expert
Dr. Michael Mahler began his scientific career at the University of Heidelberg (laboratory of Prof. E. Bautz and Dr. M. Blüthner), earning his PhD in Molecular Genetics and Immunology. During his doctoral studies, he conducted research at the Scripps Research Institute (La Jolla, California, US) under Professors Eng Tan and Michael Pollard, both internationally recognized pioneers in autoimmune disease research.
Throughout his career, Dr. Michael Mahler has held senior scientific and leadership positions at several diagnostic companies, where his transformative work has led to the discovery of novel autoantigens and the development of innovative diagnostic solutions. His scientific contributions have resulted in over 300 peer-reviewed publications and numerous patents, advancing the accurate diagnosis of autoimmune diseases. Driven by deep interest in molecular mechanisms and biomarkers in systemic autoimmune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and myositis, Dr. Mahler’s vision is to enable precision medicine in autoimmunity.
Prior to joining Exagen as Chief Scientific Officer, he served as Senior Vice President of Research Development and Business Development at Werfen, where he was responsible for all development programs in the autoimmunity field, including instruments, software, and reagents.
Key takeaways:
- Get a practical end-to-end framework for autoimmune IVD development – from biomarker strategy and assay design through tothrough clinical utility.
- Avoid common pitfalls that weaken performance (reagent variability, standardization gaps, cut-off challenges) and learn how to mitigate them.
- Build stronger standardization with the right calibrators/controls to improve reproducibility across lots, sites, and time.
- Understand the regulatory + commercialization pathway and what evidence matters to move from development to adoption.
- Sustain performance after launch with proficiency testing, harmonization efforts, and post‑market quality monitoring.
Who should attend?
This webinar is designed for professionals involved in autoimmune disease research, diagnostics, assay development, and clinical testing, including:
- IVD serology assay manufacturers including R&D, technical, procurement, and product teams
- Calibrator and control developers supporting autoimmunity portfolios
- R&D and immunoassay development contacts evaluating relevant biomarkers, assay components, and comprehensive marker panels
- Product and roadmap decision makers responsible for prioritizing autoimmunity assay development, portfolio expansion
- Researchers and academics including R&D scientists studying myositis, autoantibodies, inflammatory myopathies
