Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a prevalence of 20-50 per 100,000 individuals in European cohorts. Up to half of patients develop Lupus Nephritis (LN), and 10-20% of those progress to end-stage renal failure requiring dialysis. Although anti-dsDNA antibodies are well-established for diagnosing and monitoring SLE, the current reliance on kidney biopsies to confirm LN highlights an urgent need for a reliable, non-invasive diagnostic method.
Existing approaches do not offer a validated biomarker to detect kidney involvement in SLE. To address this limitation, recent analyses of an SLE cohort identified a specifically guanidylated form of the protein YB-1 (YB-1-2G), detectable in serum at particularly high levels in patients with active SLE and LN. Corresponding autoantibodies (Anti YB-1-2G) were also detected. Based on these results, two Enzyme-Linked Immunosorbent Assay (ELISA)-based approaches are currently in development:

1. An ELISA for detecting YB-1-2G in serum, initially using a polyclonal antibody with plans to transition to a monoclonal antibody for greater specificity.

2. A second ELISA to identify circulating autoantibodies against YB-1-2G.

These innovations are designed to significantly improve patient care by providing a non-invasive diagnosis of LN.