Published date: 5/29/2026

Value Proposition: Urine-based biomarkers that can be used for early detection and diagnosis of kidney disease non-invasively.

Technology Description

Researchers at Washington University in St. Louis have identified three sensitive, urine-based biomarkers of kidney disease that could be used for non-invasive, early detection and clinical trials monitoring. These mechanistic biomarkers are associated with the endoplasmic reticulum (ER) stress which plays a critical pathogenic role in a range of renal disorders (e.g., autosomal dominant tubulointerstitial kidney disease (ADTKD), autosomal dominant polycystic kidney disease (ADPKD), focal segmental glomerulosclerosis, Alport syndrome, acute kidney injury and diabetic nephropathy etc). Endoplasmic reticulum (ER) stress and disrupted proteostasis contribute to the pathogenesis of a variety of glomerular and tubular diseases. Because of this, detecting ER stress in the early stage of disease is imperative to enable early intervention, prevent kidney damage and enable precision therapy.

This technology provides three different protein biomarkers that can be found in patient urine prior to clinical manifestation of the disorder, chronic kidney disease or significant proteinuria. These biomarkers could enable early diagnosis/prognosis to quickly identify patients at high risk for disease progression thereby expediting clinical decision making and early treatment. In addition, these biomarkers could be used in clinical trials to monitor treatment response or guide development of ER stress-modulating drugs, dramatically reducing the amount of follow-up time to determine treatment efficacy.

Stage of Research

Have validated three different mechanistic biomarkers in animal models and samples from human patients. Each of the markers is excreted in urine and identifies ER stress before clinical manifestations of the corresponding kidney disease. Have also shown the relationship between biomarker concentration and severity of ER stress-related kidney injury.

Publications

• Kim, Yeawon, et al. “Ultrabright plasmonic-fluor nanolabel-enabled detection of a urinary ER stress biomarker in autosomal dominant tubulointerstitial kidney disease.” Am J Physiol Renal Physiol 321(2): F236-F244 (2021)

• Kim, Yeawon, et al. “Elevated urinary CRELD2 is associated with endoplasmic reticulum stress–mediated kidney disease.” JCI Insight 2(23): e92896 (2017)

• Kim, Yeawon, Sun-Ji Park, and Ying Maggie Chen. “Mesencephalic astrocyte-derived neurotrophic factor (MANF), a new player in endoplasmic reticulum diseases: structure, biology, and therapeutic roles.” Translational Research 188: 1-9 (2017)

• Kim, Yeawon, et al. “Mesencephalic Astrocyte–Derived Neurotrophic Factor as a Urine Biomarker for Endoplasmic Reticulum Stress–Related Kidney Diseases.” Journal of the American Society of Nephrology 27: 2974-2982 (2016)

Applications

• Biomarkers for early diagnosis of kidney disease

• Monitor and predict kidney disease progression

• Evaluate treatment response in targeted clinical trials

Key Advantages

• Biomarkers detect ER stress early, which occurs before significant proteinuria and prior to loss of kidney function

• Urine-based biomarkers avoid blood draw or kidney biopsy

• Biomarkers effectively discriminate between patients with ER stress-related kidney diseases and controls

• Biomarker readouts for investigative therapeutics in clinical trials

Patents

• Methods of detecting biomarkers of endoplasmic reticulum (ER) stress-associated kidney diseases (U.S. Patent No. 10,156,564)

• Additional patent application pending

Related Web Links – Maggie Chen Profile; Chen Lab