Research & Development
Our main objective remains unchanged— using R&D to drive even better results and promote innovation in our areas of specialization to benefit our society.
Thanks to our continuous investment in R&D and dedicated specialized teams, we have been at the forefront of decades of landmark discoveries, including the first direct-reading pH/blood gas analyzer and the invention of CO-oximetry, the first fully automated coagulation system, as well as more than 50 biomarkers in the autoimmunity market.
Hemostasis and Acute Care Diagnostics
A record year for R&D, 2023 was like no other in our 57-year history of innovation in Specialized Diagnostics. Two major advancements—in our Hemostasis and Acute Care Diagnostics business lines—achieved key regulatory clearances in 2023. These products will fundamentally change the paradigm for diagnostic testing in their respective clinical areas of focus.
With automated performance verification and advanced connectivity, Werfen’s R&D team delivered the new ACL TOP Family 70 Series, the next generation of Integrated Hemostasis systems, for hospitals and laboratory networks. The ACL TOP 970 CL also adds chemiluminescent technology to the family, for a greater testing breadth and significant efficiency improvements.
Once deemed impossible, the Acute Care R&D team introduced a breakthrough in point-of-care blood gas testing. Utilizing acoustofluidic technology and optical detection, the new GEM Premier 7000 with iQM3 detects hemolysis in whole blood samples and flags impacted potassium results. This helps reduce sample recollection and patient management delays thereby improving patient care.
These two products are representative of the innovation embedded in our processes and mindset. With a significant investment in R&D, pipeline full of exciting innovations, and talented R&D teams, we look forward to delivering more clinically impactful solutions—all designed to power patient care.
Dr. Anne Winkler & Brian Walker
VP Reagent Development and Medical Affairs (Anne)
& VP Instrument Development (Brian),
Hemostasis and Acute Care Diagnostics
Transfusion
Transfusion R&D is passionate about and dedicated to developing novel and innovative diagnostic products that help ensure and improve blood transfusion compatibility and drive transfusion therapy benefits for patients.
Our Transfusion R&D program is built around three strategic pillars: Reagent and assays, Automation, and Data management solutions. We have active programs around each element of our strategy.
In 2023, we continued our journey to update and introduce new content on our widely adopted NEO Iris and ECHO Lumena automation platforms, which leverage our proprietary Capture reagents, as well as traditional reagents.
We also continued to focus on and execute an exciting innovation pipeline to ensure our automation offerings are competitive.
We have been making a bigger impact on our customers with our innovative ImmuLINK Data Management solution. Recently, we launched the Panel ID module, which automates and optimizes the process of antibody identification for clinical professionals. We aim to redefine the standard of care through this new module.
In 2023, we were extremely busy with regulatory work, while also focusing on our on-market products to meet the requirements of the European market. I am proud to share that we successfully obtained the necessary product certificates within our scope.
Sukanta Banerjee
VP R&D,
Transfusion and Transplant
Autoimmunity
I am proud to share the progress the Autoimmunity R&D team made during 2023, which includes the expansion of the Aptiva® reagent menu. Key milestones in our mission to deliver our legacy assays on our state-of-the-art analyzer include: clearance of Aptiva Connective Tissue Diseases (CTD) Essential by the FDA and the completion of Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents development.
In addition, our talented R&D team established new biomarkers and concepts that led to newly filed intellectual property. We continued our efforts in precision medicine and pharma collaborations, which resulted in three collaboration agreements with top pharma companies.
More specifically, Autoimmunity R&D was awarded the Inflammatory Bowel Disease QuickFire Challenge Innovation Award from Johnson & Johnson Innovation.
Based on these accomplishments and continued investment in R&D, we are poised to achieve a very successful 2024.
Michael Mahler
VP R&D and Business Development,
Autoimmunity
Transplant
I am proud to share that in 2023, the Transplant R&D team continued to bring about customer focused products to the market.
In HLA typing, MIA FORA NGS MFlex XP and MIA FORA v5.3 software for RUO (Research Use Only) markets were launched. MIA FORA NGS MFlex XP features expanded coverage of all major HLA gene regions. The extensive gene coverage, combined with an efficient workflow and a powerful data analysis system, leads to clear HLA typing results and minimal ambiguities.
In HLA antibody detection, we launched LIFECODES NEXA Class II to the RUO market, along with MATCH IT! Antibody Software v1.5.1. LIFECODES NEXA Class II is an addition to the LIFECODES Single Antigen products used to detect HLA IgG antibodies to aid donor and recipient matching in organ transplantation. The NEXA Class II, by leveraging Luminex FM3D flow analyzer, has an expanded panel of HLA antigens. With this broader coverage, the users can report higher resolution results, ultimately leading to better donor selection and improved patient care. LIFECODES NEXA Class I RUO and the next generation of the MATCH IT! Software will be launched in 2024.
During 2023, we continued to support our IVDR efforts. This endeavor embodies strong cross-functional teamwork that is critical to its success.
As sustained innovation requires great collaborators, our team continues to engage with other companies and academic institutions, sharing ideas and developing a focused vision to ultimately bring about new and innovative diagnostic tools to the field of transplantation.
The achievements not only reflect the talent and dedication of our team, but also the strong collaboration with laser-focused, cross-functional teams. We look forward to an even more productive 2024.
Sukanta Banerjee
VP R&D,
Transfusion and Transplant
OEM
During 2023, we progressed significantly in our pipeline of immunoassay products for Hemostasis and our OEM partners. In addition to developing new assays for our portfolio, we advanced in several next-generation assays with enhanced performance, and in migrating assays to new platforms.
The Biotechnology team was reorganized in 2023 to gain efficiency and agility as we expand our biomaterials catalog. Our biomaterials are customized for the IVD industry and chemiluminescence screening, and prototyping is included in the development to ensure high performance on the state-of-the-art instruments. We also signed license agreements to internalize the production of key biomaterials for immunoassay manufacturing to secure the supply and control the quality of critical raw materials.
Our Innovation pipeline continues to evolve by evaluating novel biomarkers with Key Opinion Leaders and assessing new technologies for the development of immunoassays and biomaterials.
A Product Lifecycle Management team was established within R&D to provide technical guidance for regulatory requirements for worldwide registrations and to execute any required verification and validation activities post-launch.
Our digital strategy included automating data acquisition, statistical analysis, report generation, and document management, as well as tools for project and resource management.