Leadership of NIH Support Laboratory:
Our leadership team, consisting of Director Dr. Frazer-Abel and Associate Director Dr. Nandakumar, brings over three decades of combined experience in complement, autoimmune, and immunoinflammatory testing. They are both committed to and passionate about quality analysis and reporting as well as shaping the next generation of scientists.
Ashley Frazer-Abel, PhD, D(ABMLI)
Director, Exsera BioLabs
Dr. Frazer-Abel is the Director of Exsera BioLabs, Medical Director of our complement specialty section and Associate Professor of Medicine at the University of Colorado Anschutz Medical Campus. She has a strong background in complement and autoimmune testing for both patient diagnostics and clinical trials, having served as Principal Investigator or Contributing Scientist for the complement analysis for a few hundred non-clinical and clinical trials.
In addition, she has a strong interest in the development and validation of novel assays to expand our available testing for complement diagnostics and drug development. Dr. Frazer-Abel has decades of experience in the regulatory landscape and with requirements for diagnostic testing, as well as for compliance with the US FDA GLP and GCP regulations.
Dr. Frazer-Abel has a strong dedication to improving the consistency and standardization of complement testing, as exemplified by her serving as co-chair of the International Complement Society and International Union of Immunological Societies Committee for the Standardization and Quality Assessment of Complement Measurements. In addition to this role, she is also actively involved in the ICS as the current treasurer as well as serving as Chair of the Education Committee for the Association of Medical Laboratory Immunologists.
Dr. Frazer-Abel has co-authored numerous book chapters, invited reviews and peer-reviewed articles pertaining to the field of complement. She is also passionate about fostering the next generation of complementologists and has even made great efforts to start an American based conference to facilitate this participation and connection between established and beginning complementologists. (specifically, C3A, Collaborative Complement Congress of the Americas)
As the demand and complexity for complement testing expands, Dr Frazer-Abel is excited to share her experience and insights to assist the needs of our clients as well as looking forward to advancing our offerings. She takes great pride in her work and thoroughly enjoys collaborating with others to help advance their research and goals. Her talks and presentations on the complement system have been widely appreciated and she is often looked to for consultation for her expertise on this topic.
Vijayalaksmi (Viji) Nandakumar, PhD, DABCC
Associate Director, Exsera BioLabs
Dr. Vijayalakshmi (Viji) Nandakumar is the Associate Director of Exsera BioLabs and the Medical Director of Autoimmunity Testing at the University of Colorado School of Medicine, where she also serves as an Assistant Professor. With extensive training and experience in autoimmune and complement disease testing across large reference laboratories and hospital systems, Dr. Nandakumar has a strong foundation in regulatory compliance, particularly with CAP/CLIA and NY-accredited labs. She is skilled in the implementation, validation, and clinical interpretation of complex immunology tests, ensuring strict adherence to regulatory standards across diverse clinical settings.
Dr. Nandakumar has authored numerous peer-reviewed publications and book chapters. She is also actively involved in professional organizations, serving as an executive officer of the Clinical and Diagnostic Immunology division of the American Association for Diagnostics and Laboratory Medicine (ADLM) and as Secretary-Elect for the Association of Medical Laboratory Immunologists (AMLI).
Her research focuses on advancing diagnostic approaches for autoimmune and complement diseases, exploring novel biomarkers, and optimizing diagnostic stewardship. Dr. Nandakumar is also passionate about mentoring the next generation of clinicians, enhancing the education of medical students, residents, and fellows in clinical immunology and laboratory medicine.
With her deep regulatory expertise, practical approach to clinical testing challenges, and willingness to share her knowledge, Dr. Nandakumar is a trusted consultant in autoimmune disease testing. She is committed to supporting her clients' needs, collaborating on innovative research, and providing expert guidance to improve patient care.
V. Michael Holers, MD
Clinical Research Consultant
Dr. Holers is currently Professor of Medicine and Immunology and the Scoville Professor of Rheumatology. The focus of the Holers’ laboratory research efforts has been on the structure-function relationships and biologic roles of the complement system in autoimmune and inflammatory diseases, using both human disease and murine model studies. More recently his research group has moved a major focus of research activities to studying the natural history and pathogenesis of human rheumatoid arthritis (RA) prior to and immediately after the onset of clinically apparent arthritis. Dr. Holers has also directed for 15 years the Rheumatology Clinical Laboratory wherein human autoantibody testing is performed.
The Exsera BioLabs Team
Exsera BioLabs is a leading specialty laboratory dedicated to complement, autoimmunity, and autoinflammatory testing, located within the University of Colorado’s Anschutz Medical Campus. Our team comprises seasoned professionals with over a decade of expertise in the field. Integrated within the rheumatology division, we thrive on active collaborations that drive innovation and enhance patient care.
We offer a comprehensive menu of over three dozen validated diagnostic tests for both autoimmune and complement conditions, all compliant with CAP/CLIA standards and with the US FDA GXPs. Our research initiatives span a wide range of areas within complement and autoimmune diseases, including diabetic retinopathy, age-related macular degeneration, rheumatoid arthritis, systemic connective tissue diseases, and other inflammatory conditions. These partnerships inform our ongoing development of new tests, ensuring we meet the evolving needs of physicians, particularly those utilizing complement therapeutics and emerging autoimmune markers.
At Exsera, we pride ourselves on providing customized solutions that address our clients' unique challenges. We support both adult and pediatric hospitals on campus, as well as an expanding network of outlying hospitals and practices.
Since our founding in 2016, Exsera has established itself as a recognized leader in complement immunobiology. In addition to our extensive human testing capabilities, we also provide services for non-human primates and select tests for canines and mice. Our laboratory is committed to delivering high-quality, timely results and insights, all while maintaining a client-focused approach that enhances the success of our partners and their projects.