Urinary Biomarker Assay Predicts Kidney Disease Progression Beyond Standard Measures

Earlier identification of patients at greatest risk could support more timely intervention.

New data presented at the 86th Scientific Sessions of the American Diabetes Association (ADA) highlighted a urinary biomarker assay that predicts renal outcomes independently of traditional measures. Analysis of the landmark CREDENCE Trial suggests the assay may enable earlier and more precise risk stratification beyond albuminuria and eGFR.

Bio Preventive Medicine Corp. (Zhubei City, Taiwan) and Precision Diabetes (Raleigh, NC, USA) reported results for DNlite, a laboratory assay designed to assess renal risk in diabetic kidney disease. The data were presented as a late-breaking abstract at the ADA 86th Scientific Sessions and focus on the assay’s ability to add prognostic value beyond current renal biomarkers. The companies positioned the work within the context of ongoing challenges in identifying patients who remain at risk despite modern therapies.

DNlite measures urinary post-translationally modified Fetuin-A (uPTM-FetA), described in the presentation as a novel biomarker associated with kidney stress, inflammation, metabolic dysregulation, and progressive renal injury. By quantifying uPTM-FetA in urine, the assay targets a biological signal that is not fully captured by conventional renal markers. The approach is intended to help identify patients who may remain at elevated risk for disease progression.

The presentation evaluated baseline DNlite results from 2,429 CREDENCE participants, including both placebo- and canagliflozin-treated patients. The analysis was based on CREDENCE, a landmark international renal outcomes trial that helped establish sodium-glucose cotransporter 2 inhibitors as foundational therapy in diabetic kidney disease. Despite these advances, many patients remain difficult to risk stratify using conventional measures such as albuminuria and eGFR.

Across the analysis, DNlite independently predicted adverse renal outcomes after multivariable adjustment. Renal risk rose progressively across uPTM-FetA tertiles and quartiles. Kaplan–Meier analyses showed significant risk stratification in both the placebo and treatment arms. The assay provided prognostic information beyond traditional renal markers, including albuminuria and eGFR.

“DNlite reflects a unique aspect of kidney stress biology that is not fully captured by traditional renal markers alone. The consistency of these findings across both untreated and treated populations strengthens our confidence in the clinical relevance of this biomarker platform,” said Karen Tseng, CEO of Bio Preventive Medicine Corp.

“Residual renal risk remains a major challenge in patients with type 2 diabetes and CKD, even in the era of SGLT2 inhibitor therapy. This analysis demonstrates that the DNlite assay provides independent prognostic information beyond conventional clinical parameters and may help refine renal risk assessment in this population,” said the late Professor Ele Ferrannini, Emeritus Investigator of the National Research Institute of Clinical Physiology, a renowned leader in diabetes and metabolic disease research and senior author of the study.

Related Links
Bio Preventive Medicine Corp.
Precision Diabetes