Biomarkers have the potential to transform how lupus is diagnosed, monitored, and treated. Yet despite major advances in lupus research, the biomarkers used routinely in the clinic have changed little over the past 30 years. A new publication in Rheumatology outlines a roadmap – developed as part of the Lupus Research Alliance’s Biomarker Roadmap initiative – for overcoming the barriers that have slowed progress and accelerating the development of biomarkers that could improve the lives of people living with lupus.
Biomarkers are measurable molecules found in blood, other body fluids, or tissues that can provide information about a person’s health. In lupus, biomarkers may help doctors diagnose disease earlier, track disease activity, predict flares, monitor organ involvement, and determine whether a treatment is working for a particular patient.
While researchers have identified many promising biomarker candidates, very few have made the leap from discovery in the lab to routine clinical use. Key barriers include the heterogeneity of the disease, limited resources available to develop well-qualified assays that meet regulatory standards, and the need for large-scale, coordinated studies for clinical validation.
“Biomarker research has long been one of the most significant challenges in lupus – with efforts fragmented, and progress toward clinical adoption slow,” said Alfred Kim, MD, PhD (Washington University School of Medicine). “For people living with lupus, the consequences are significant. That means fewer tools to monitor disease activity, predict treatment response, and avoid potentially invasive procedures, such as kidney biopsies.”
A Roadmap to Move Lupus Biomarkers from Discovery to Patient Care
Recognizing these challenges, the Lupus Research Alliance launched an initiative in 2025 to develop a strategic roadmap for lupus biomarker research, development, and translation. A multidisciplinary committee of rheumatologists, scientists, industry leaders, and diagnostics experts led by Dr. Kim and Peter Schafer, PhD (PROLIFIC Consortium Pulmonary Fibrosis Foundation, formerly Bristol Myers Squibb), worked alongside a larger group of researchers, clinicians, and people living with lupus to identify the field’s most pressing unmet needs and promising opportunities. The effort included a comprehensive literature review, surveys, and expert discussions, with patient perspectives incorporated throughout the process. Through these efforts, the committee identified priority areas where new biomarkers could have the greatest impact, including improving the diagnosis of systemic lupus erythematosus (SLE) and neuropsychiatric lupus, developing better measures of disease activity in SLE and lupus nephritis, and predicting disease progression and treatment response.
Importantly, both the publication and the Lupus Research Alliance’s Biomarker Roadmap emphasize that scientific discovery alone is not enough. Many promising biomarkers stall during various stages, including robust assay development and qualification required to demonstrate accuracy and reproducibility, validation (proving that a candidate biomarker gives clinically meaningful results), regulatory approval (such as certification under Clinical Laboratory Improvement Amendments [CLIA] standards needed for a Laboratory Developed Test [LDT], or approval under the FDA’s Biomarker Qualification Program [BQP] or as an In Vitro Diagnostic [IVD] medical device), and clinical adoption (the integration and routine use of the biomarker into everyday medical practice). One of the paper’s key conclusions is that progress will require coordinated action across the lupus community through multi-partner consortia-based efforts.
“For lupus biomarkers to help in treating people living with this disease, the field must align around coordinated, focused efforts,” said Dr. Schafer. “Consortium-based collaborations that enable consensus-building, data and sample sharing, collective funding, and large-scale validation studies may offer the best opportunity to bring new biomarkers into clinical use.”
By identifying the field’s most pressing challenges and proposing a framework for addressing them, the roadmap serves as a call to action for the lupus community to work together to accelerate progress and deliver better tools for people living with lupus.
Tags: Clinical Laboratory Improvement Amendments, Dr. Peter Schafer, PROLIFIC Consortium Pulmonary Fibrosis Foundation, Biomarker Roadmap, Alfred Kim, Rheumatology, Biomarker Qualification program