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.
We can shorten the time it takes to diagnose autoimmune diseases and improve their prognosis and monitoring. With more accurate testing and comprehensive data, physicians can be more empowered to enhance patient care.
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 in 2023
Significant advancements in our innovation program
As a market leader in autoimmune diagnostics, we are dedicated to improving the lives of the millions of people living with autoimmune diseases globally. Recognizing the often-prolonged diagnostic journey for many patients, our portfolio of innovative instruments and assays is focused on helping clinicians diagnose patients with autoimmune diseases earlier.
In 2023, we made significant advancements in our innovation program in Autoimmunity. Aptiva®, our fully automated, multi-analyte, next-generation high throughput instrument secured US FDA 510(k) clearance for the Connective Tissue Diseases (CTD) Essential reagent.
We also completed FDA and the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) submissions for Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents. In addition to the forthcoming APS, and previously cleared CTD and Celiac Disease assays, Aptiva will target additional autoimmune disease states, and has over 60 analytes at various stages of advanced development.
Our BIO-FLASH® chemiluminescent analyzer continues to contribute to our growth strongly, with an outstanding 11% growth in sales in 2023. This was complemented by the sustained strength of our ELISA and immunofluorescence assays (IFA), as well as the QUANTA Link® data management system, the cornerstone of our comprehensive autoimmunity offering that streamlines the laboratory workflow.
We continued to develop partnerships with pharmaceutical companies with a focus on innovation and specialization. With 3 of the 10 largest pharmaceutical companies now as our partners, we focus on leveraging biomarkers to improve the lives of autoimmune patients.
But most importantly, our people are the reason for our continued success. In 2023, we focused on building our talent pool further and investing in their growth and development.
With continued growth and expansion of our disease menu, and focus on our people and innovation, we have a solid foundation to deliver an even more successful 2024.