Beyond the Numbers: A New Test Unmasks Hidden Kidney Risk in Diabetes

RALEIGH, NC – June 05, 2026 – For millions living with type 2 diabetes, the specter of kidney failure is a constant, life-altering threat. For decades, clinicians have relied on two key metrics—albuminuria and eGFR—to monitor kidney health. But these tools have a critical blind spot, often identifying damage only after it has become significant. This week, at the prestigious American Diabetes Association (ADA) 86th Scientific Sessions, a potential paradigm shift emerged. New findings from a landmark clinical trial suggest a novel diagnostic assay, DNlite™, can see what other tests miss, offering a powerful new way to predict and manage diabetic kidney disease (DKD).

Two companies, Taiwan-based Bio Preventive Medicine Corp. and North Carolina's Precision Diabetes, Inc., presented a late-breaking analysis demonstrating that their DNlite™ test can independently predict adverse renal outcomes in high-risk patients. By analyzing samples from the famous CREDENCE trial, the study shows this innovative tool could fundamentally change how we identify and protect the most vulnerable individuals from one of diabetes's most devastating complications.

The Persistent Problem of 'Residual Risk'

The backdrop for this announcement is one of both triumph and frustration in modern medicine. The very trial from which this new data was sourced, CREDENCE, was a landmark study that helped establish a class of drugs known as SGLT2 inhibitors as a cornerstone of treatment for diabetic kidney disease. These drugs have been revolutionary, significantly slowing the progression to kidney failure for many.

Yet, a stubborn problem remains: 'residual renal risk.' Even on the best available therapies, a significant number of patients continue to experience a steady decline in kidney function. The current diagnostic toolkit, primarily measuring protein in the urine (albuminuria, or UACR) and estimating the kidney's filtration rate (eGFR), is insufficient to pinpoint exactly who these patients are before it's too late. These markers are often lagging indicators of damage rather than leading indicators of stress.

"Residual renal risk remains a major challenge in patients with type 2 diabetes and CKD, even in the era of SGLT2 inhibitor therapy," noted the late Professor Ele Ferrannini, a senior author of the study, in a statement provided by the companies. This diagnostic gap means that opportunities for earlier, more aggressive intervention are often missed, leaving patients on a slow but steady path towards dialysis or transplantation.

A New Window into Kidney Stress

The DNlite™ assay offers a different approach. Instead of measuring the consequences of damage, it detects a precursor: stress. The test measures a specific biomarker in the urine called post-translationally modified Fetuin-A (uPTM-FetA). This molecule acts as an early warning signal, reflecting a unique biological pathway of kidney stress, inflammation, and metabolic dysfunction that is not fully captured by eGFR or albuminuria.

The new analysis evaluated baseline urine samples from 2,429 participants in the CREDENCE trial, which included patients receiving either a placebo or the SGLT2 inhibitor canagliflozin. The results were compelling. The DNlite™ test independently predicted which patients would suffer adverse renal outcomes, even after adjusting for all conventional risk factors, including baseline eGFR and UACR levels. The risk of kidney failure increased progressively with higher levels of the uPTM-FetA biomarker. Crucially, this predictive power held true for patients in both the placebo group and the treatment group, demonstrating its utility even in the context of modern therapy.

"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." This suggests the test could help clinicians identify patients who, despite appearing stable on standard tests, are silently progressing towards kidney failure and may require more intensive management.

Reshaping the Diagnostic Landscape

For the companies behind the test, this new data is a significant validation of their mission to bring precision medicine to diabetes care. Bio Preventive Medicine Corp. is a clinical-stage biotech focused on precision diagnostics, while Precision Diabetes aims to revolutionize diabetes assessment with novel biomarkers. Their collaboration on the DNlite™ platform represents a strategic push into a market with a profound unmet need.

This is not merely a theoretical finding from a research lab. Bio Preventive Medicine has already secured marketing approval for its DNlite™ test kit in multiple countries, including Singapore, Malaysia, Thailand, and within the European Union, signaling a clear path toward clinical adoption. The goal is to integrate the test into standard clinical practice, providing doctors with a crucial data point to personalize treatment strategies.

While other novel biomarkers for kidney disease are in development, the robust validation of DNlite™ within a landmark trial like CREDENCE gives it a significant competitive advantage. It provides the kind of high-quality evidence that regulatory bodies, insurance payors, and clinical guideline committees look for when evaluating new technologies.

A Final, Lasting Contribution

The presentation at the ADA sessions was tinged with poignancy. Professor Ele Ferrannini, a world-renowned leader in diabetes research and senior author on the study, passed away shortly before these findings were made public. Professor Ferrannini was a titan in the field, a recipient of the Banting Medal for Scientific Achievement—the ADA's highest honor—and an author of over 700 scientific papers.

His life's work was dedicated to unraveling the complex mechanisms of type 2 diabetes and its complications. His involvement lends immense credibility to this research, underscoring its scientific rigor and potential impact. The posthumous presentation of this work serves as a powerful tribute to his legacy, representing a final contribution to the field he shaped so profoundly. This new analysis, demonstrating how a novel biomarker can refine risk assessment beyond conventional methods, perfectly aligns with his career-long quest for a deeper, more integrated understanding of diabetes. The findings stand as a testament to his enduring vision and commitment to improving the lives of patients worldwide.