Autoimmunity
A global leader in autoimmune diagnostics

Through a dedicated focus on autoimmune in vitro diagnostics and lab automation, we anticipate the needs of the world’s most advanced laboratories and clinics. We are a global market leader in autoimmune diagnostics, delivering highly accurate reagents and systems that enhance patient care and help laboratories improve the efficiency and quality of testing. Our solutions support the diagnosis, stratification and monitoring of complex disorders such as connective tissue diseases, rheumatoid arthritis, antiphospholipid syndrome, vasculitis and celiac disease.

Fast, efficient, autoimmune disease diagnosis

Autoimmune diagnosis is complex. Clinical symptoms vary, and often overlap with those of other diseases. For many patients with Autoimmune diseases, it can take years to receive a correct diagnosis 1, 2, 3. During this time, the disease may progress and lead to delays in treatment, potential complications, a toll on mental health, and direct and indirect costs 4, 5.

References:
- Benaroya Research Institute. Diagnosing autoimmune diseases 2017. Available at: www.benaroyaresearch.org/blog/diagnosing-autoimmune-diseases
- Sloan M et al. Medically explained symptoms: a mixed methods study of diagnostic, symptom and support experiences of patients with lupus and related systemic autoimmune diseases. Rheumatology Advances in Practice 2020
- Fuchs V et al. Delayed celiac disease diagnosis predisposes to reduced quality of life and incremental use of health care services and medicines: a prospective nationwide study. United European Gastroenterol J 2018
- IQVIA. Global medicine spending and usage trends: outlook to 2025. IQVIA 2021
- Fuchs et al. Delayed celiac disease diagnosis predisposes to reduced quality of life and incremental use of health care services and medicines: a prospective nationwide study. United European Gastroenterol J 2018
Improving care for patients living with autoimmune diseases
Autoimmunity occurs when the body’s immune system fails to recognize itself, resulting in antibodies to de directed against the body’s own tissues (autoantibodies). Autoimmune diseases are caused by autoantibodies and include rheumatoid arthritis, systemic lupus erythematosus, celiac disease, and many other diseases.
Our highly accurate reagents and automated systems are designed to serve labs of all sizes, and they help improve the way patients with autoimmune diseases are diagnosed, monitored, and treated around the world. We partner with leading clinical researchers and laboratory professionals to deliver breakthrough after breakthrough. Each one helps improve care for millions of patients living with autoimmune diseases through enhanced quality and efficiency.
Autoimmunity


Driving innovation and growth
In 2024, we continued to reinforce our leadership in Autoimmunity, driving innovation to advance diagnostic solutions and improve the lives of millions of autoimmune patients worldwide.
Aptiva®, our fully automated benchtop system with particle-based multi-analyte technology , continued its successful innovation program by securing both a CE Mark and US FDA 510(k) clearance for the Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents. These new APS Reagents expand the robust Aptiva portfolio, which already includes the Celiac Disease and Connective Tissue Diseases (CTD) Essential Reagents. The Aptiva system is poised to be a game changer for our customers, setting a new standard in autoimmune diagnostics and a powerful driver of market share growth.
Our BIO-FLASH® chemiluminescent analyzer remained a key driver of growth, achieving an impressive 9% sales increase in 2024. This success was further supported by the continued strength of our enzyme-linked immunosorbent assays (ELISA) and immunofluorescence assays (IFA), along with the QUANTA Link® data management system—an essential component of our portfolio that optimizes laboratory workflow.
Overall, our solutions impacted ~75 million patients globally, and the overall business grew by 7.6%, with particularly strong performance in EU markets, where we achieved 13.2% growth. With a growing disease menu, a strong commitment to innovation, and a focus on our people, we are well-positioned for an even more successful 2025.
Vijay Namasivayam, Ph.D.
Chief Operating Officer,
Autoimmunity
2024 business highlights
Our people in Autoimmunity
Our products: Powering Patient Care
Integrated Lab+
A comprehensive, fully customizable solution to expand your Autoimmunity lab’s capabilities
Because a single technology can’t give you a complete view of Autoimmune disease states, you need a combination of technologies. Integrated Lab+ for Autoimmunity combines novel assays and innovative instruments with powerful lab data intelligence and unrivaled expertise.