A global leader in autoimmune diagnostics

Autoimmunity - What we do

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.

Autoimmunity - What we do

Fast, efficient, autoimmune disease diagnosis

The need we meet

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.

The need we meet


  1. Benaroya Research Institute. Diagnosing autoimmune diseases 2017. Available at:
  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 in 2023

Brian Durkin
Brian Durkin

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.

Roger Ingles
Chief Operating Officer,
  • 0 million

    in sales in 2023

  • 0 million

    tests sold around the world

  • 0 years

    of Autoimmunity expertise

2023 business highlights

US FDA 510(k) clearance for Aptiva Connective Tissue Diseases (CTD) Essential reagent

11% sales growth for BIO-FLASH chemiluminescent analyzer

New and expanded pharmaceutical company partnerships that focus on biomarker innovation

Our people in Autoimmunity

Armando García-Cáceres

Joining Werfen has proven to be a very rewarding experience. Being part of an organization at the forefront of advancing patient care is something I am proud of. Our emphasis on continuous improvement has offered me the opportunity to grow and to challenge myself. I enjoy collaborating within a growing and impactful organization.

Armando Garcia Caceres Manager, Logistics & Operational Excellence,
San Diego
Mariya Asako

I work for Werfen because it is a company dedicated to making a difference in the healthcare industry. Werfen values align with my own, and I am proud to be a part of this team. My daily work is challenging and rewarding, and the company culture is one of collaboration and support.

Mariya Asako Group Lead, ELISA Plates Manufacturing,
San Diego
Brian Gacioch

At Werfen the leadership is inspirational, the culture is dynamic, and quality is paramount. It’s an honor to be a member of the worldwide leader in autoimmune diagnostics.

Brian Gacioch Biologics Production Coordinator,
San Diego
Erin Miller

Working for Werfen has been a fantastic experience. Werfen has provided many opportunities for me to advance my career while also supporting my work-life balance.

Erin Miller Research Associate IV, R&D,
San Diego

Our products Powering Patient Care


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

Gain the efficiency of simultaneous detection of multiple analytes from a single sample aliquot while delivering excellent clinical performance and diagnostic confidence with Aptiva’s particle-based multi-analyte technology (PMAT).

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

BIO-FLASH is a fully automated, random access chemiluminescent analyzer for any autoimmune laboratory. It delivers enhanced workflow efficiencies, market leading ease-of-use and improved assay performance compared with existing enzyme-based systems.

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Flexibility and efficiency to accelerate workflow in the high-volume laboratory.

QUANTA-Lyser 3000 is a high throughput ELISA/IFA processing platform that gives you the ability to complete your workload faster with less hands-on time. That equates to maximum efficiency with increased productivity, all while safeguarding reagent and patient traceability to ensure integrity of results.

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NOVA View®

NOVA View®

Enhanced interpretation and improved workflow with digital IFA.

NOVA View is a fully automated IFA microscope – combined with an intelligent digital imaging system – that reads and archives images of IFA-stained slides. NOVA View creates a new paradigm for automating the way IFA slides are analyzed, using digital technology to read and archive IFA images.

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Centralized data and workflow management within the Autoimmunity lab.

QUANTA Link is a powerful information management system that gives you immediate control of all your Autoimmune IFA, ELISA, chemiluminescence and multi-analyte sample processing. With QUANTA Link, you can improve your productivity, simplify compliance and increase clinical confidence.

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