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:

  1. Benaroya Research Institute. Diagnosing autoimmune diseases 2017. Available at: www.benaroyaresearch.org/blog/diagnosing-autoimmune-diseases
  2. 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
  3. 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
  4. IQVIA. Global medicine spending and usage trends: outlook to 2025. IQVIA 2021
  5. 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
  • 0 million

    AID in sales in 2024

  • 0 million

    tests sold around the world

  • 0 years

    of Autoimmunity expertise

2024 business highlights

13.2% sales growth in Europe

7.6% sales growth overall

9% sales growth for BIO-FLASH chemiluminescent analyzer

Our people in Autoimmunity

Working at Werfen has been both exciting and rewarding. I take great pride in being part of a team that makes a meaningful difference in the lives of patients and their families.  

The continuous growth and daily challenges keep me motivated and drive me to excel in my role. 

Kim Galatis Buyer II
San Diego

I truly enjoy working at Werfen. The company has provided me with numerous opportunities for career growth, allowing me to develop both professionally and personally.  

From the very first, it felt like I was part of a family. The supportive and inclusive environment, coupled with great leadership, makes Werfen a place where I feel valued and motivated every day. 

Mondy Youm Instrument Engineer, Global Systems Support,
San Diego

Working at Werfen is an incredibly fulfilling experience. The collaborative culture fosters innovation based on data-driven insights, ensuring that our work has real impact.  

The company prioritizes professional growth through mentorship, continuous learning, and cross-functional teamwork, and our leadership genuinely values every contribution each employee makes. 

Shauna Wilder Data Analyst,
San Diego

I truly enjoy my career, especially the people I work with and the opportunity to interact with all departments.  

I have been with Werfen for 16 years, and there’s never a dull moment. Medical science is amazing, and I love that what we do Headquarters and Technology Center has a direct impact on improving patient health! 

Marcus Kauler Quality Assurance, Supervisor,
San Diego

From day one, I felt genuinely welcomed by everyone. The positive and friendly culture is evident at all levels of the organization.

Over the past year, I’ve built strong working relationships across many teams and gained a deep understanding of our products and the company’s rich history. I love that our work is purpose-driven and patient-focused. I feel truly fortunate to be part of the team!

Heidi Haywood Human Resources Generalist

Our products: Powering Patient Care

Aptiva®

Advancing Autoimmunity labs with next generation multi-analyte technology and automation.

Enhance clinician confidence and improve productivity and lab sustainability with Aptiva, a benchtop system with particle-based multi-analyte technology (PMAT).

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BIO-FLASH®

Taking Autoimmunity testing to a new level of performance with chemiluminescence.

Perform all Autoimmunity testing in-house with BIO-FLASH, a random-access, compact benchtop analyzer with chemiluminescent technology that makes specialized tests efficient to perform.

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QUANTA-Lyser® 3000

Streamlining high-volume ELISA and IFA testing.

Meet high demand for indirect immunofluorescence ELISA and IFA testing while lowering operational costs with QUANTA-Lyser 3000, a fully automated high-throughput processing platform designed to support the volume requirements of your lab.

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NOVA View®

NOVA View®

Automating and standardizing IFA interpretation.

Simplify processes with NOVA View, an automated digital microscope for enhanced interpretation and improved workflow for IFA.

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QUANTA Link®

Transform complex data into meaningful information with QUANTA Link.

QUANTA Link is a powerful data management system that gives you immediate control of all your Autoimmune IFA, ELISA, chemiluminescence and multi-analyte sample processing. With QUANTA Link, you can streamline workflows, elevate laboratory confidence, and empower your clinical decision-making.

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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.

Note: All sales growth numbers are at Constant Exchange Rate and Constant Perimeter.