New analysis supports DNlite™ for earlier renal risk stratification in patients with type 2 diabetes and chronic kidney disease
ZHUBEI CITY, Taiwan and RALEIGH, N.C., June 5, 2026 /PRNewswire/ — Bio Preventive Medicine Corp. and Precision Diabetes, Inc. today announced presentation of a Late-Breaking Abstract at the American Diabetes Association (ADA) 86th Scientific Sessions highlighting new findings from the landmark CREDENCE trial demonstrating that DNlite™ independently predicts adverse renal outcomes beyond conventional renal biomarkers, including albuminuria and eGFR, in patients with type 2 diabetes and chronic kidney disease (CKD).
DNlite™ measures urinary post-translationally modified Fetuin-A (uPTM-FetA), a novel biomarker associated with kidney stress, inflammation, metabolic dysregulation, and progressive renal injury. The assay is designed to help identify patients with diabetic kidney disease who may remain at elevated risk for progression beyond what is fully captured by conventional renal biomarkers alone.
CREDENCE was a landmark international renal outcomes trial that helped establish SGLT2 inhibitors as a foundational therapy for diabetic kidney disease. Despite major therapeutic advances, many patients with type 2 diabetes and CKD continue to experience progressive renal decline and remain difficult to risk stratify using conventional clinical measures alone.
The new analysis suggests the DNlite™ assay may help identify patients at persistently elevated renal risk earlier in the disease process and beyond conventional measures of kidney disease severity.
The presentation, titled “Urinary Post-Translationally Modified Fetuin-A Predicts Renal Outcomes Independent of Albuminuria and eGFR in Type 2 Diabetes and CKD: CREDENCE Analysis,” evaluated baseline DNlite™ assay results in 2,429 participants from the CREDENCE trial, including both placebo-treated and canagliflozin-treated participants.
Key findings from the analysis include:
- DNlite™ independently predicted adverse renal outcomes after multivariable adjustment
- Renal risk increased progressively across uPTM-FetA tertiles and quartiles
- Kaplan–Meier analyses demonstrated significant risk stratification across both placebo and treatment arms
- The assay provided prognostic information beyond traditional renal markers including UACR and eGFR
“DNlite™ reflects a unique aspect of kidney stress biology that is not fully captured by traditional renal markers alone,” said Karen Tseng, CEO of Bio Preventive Medicine Corp. “The consistency of these findings across both untreated and treated populations strengthens our confidence in the clinical relevance of this biomarker platform.”
“Residual renal risk remains a major challenge in patients with type 2 diabetes and CKD, even in the era of SGLT2 inhibitor therapy,” said Ele Ferrannini, Emeritus Investigator of the National Research Institute of Clinical Physiology. “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.”
The companies believe the DNlite™ assay represents a promising next-generation biomarker approach for improving early DKD risk stratification and identifying residual renal risk in high-risk patients.
Additional Statement: Professor Ele Ferrannini, a renowned leader in diabetes and metabolic disease research and senior author on the study, passed away shortly before the presentation of these findings at the ADA Scientific Sessions. Precision Diabetes and Bio Preventive Medicine are honored to recognize his longstanding scientific contributions and collaboration on this work.
About Bio Preventive Medicine Corp.
Bio Preventive Medicine Corp. is a clinical-stage biotechnology company focused on advancing precision diagnostics for kidney disease and chronic metabolic disorders. The company develops biomarker-driven solutions designed to enable earlier disease detection, improved renal risk stratification, and more personalized patient management. Bio Preventive Medicine is advancing diagnostic platforms spanning in vitro diagnostics (IVDs) and laboratory-developed testing services to address unmet clinical needs in renal and chronic disease care.
About Precision Diabetes, Inc.
Precision Diabetes, Inc. (Raleigh, North Carolina) is an emerging leader in enabling precision medicine for diabetes by using novel diabetes biomarkers and algorithms. The company’s mission is to revolutionize the diagnostic assessment of diabetes by providing a spectrum of unique diabetes tests, spanning the risk of developing diabetes to developing diabetes complications.
Media Contact:
Eric Button
Ebutton@precisiondiabetesinc.com
919-280-3482
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SOURCE Precision Diabetes, Inc.
