A unique aspect of kidney stress biology that conventional tests overlook
In the long effort to see illness before it fully arrives, researchers presented findings this week suggesting that a protein fragment in urine — long overlooked by conventional medicine — may reveal kidney danger in diabetic patients that standard tests cannot. Analyzed across nearly 2,500 participants in a landmark international trial, the DNlite biomarker independently predicted kidney disease progression even in patients already receiving the best available treatments. The work, partly shaped by a scientist who did not live to see it presented, reflects medicine's persistent search for earlier, truer signals of harm — and the human cost of the gap between what we can measure and what is actually happening inside the body.
- Even with powerful modern drugs, many diabetic patients continue losing kidney function — a stubborn residual risk that current tests are too blunt to reliably identify.
- Two biotech firms brought a potential answer to the field's largest annual gathering, presenting data showing their urine-based assay caught danger signals that albuminuria and eGFR quietly missed.
- Across nearly 2,500 trial participants — both treated and untreated — higher DNlite levels tracked consistently with worse kidney outcomes, lending the biomarker a dose-response credibility that is difficult to dismiss.
- The death of a senior researcher before the presentation added weight to the urgency: diabetic kidney disease remains a leading driver of dialysis, and the window for intervention is narrow.
- The test now faces the harder journey from promising laboratory finding to validated clinical tool — one that must prove it can change not just risk scores, but actual patient outcomes.
Researchers from two biotechnology companies presented findings this week at the American Diabetes Association's annual scientific conference suggesting that a novel urine-based test could identify diabetic patients at high risk of kidney failure earlier and more precisely than current methods allow.
The test, called DNlite, measures urinary post-translationally modified Fetuin-A — a protein fragment that appears to reflect kidney stress, inflammation, and metabolic dysfunction. Doctors today rely primarily on two measures to assess kidney health in diabetic patients: albuminuria, which detects protein leakage, and eGFR, which estimates filtration capacity. These tools are useful but incomplete. Some patients who appear stable by these standards continue to deteriorate; others at apparent high risk do not. The result is a persistent imprecision that leaves clinicians uncertain about who truly needs more aggressive care.
Bio Preventive Medicine Corp. and Precision Diabetes, Inc. analyzed baseline DNlite measurements from 2,429 participants in the CREDENCE trial — the landmark study that helped establish SGLT2 inhibitors as standard treatment for diabetic kidney disease. They found that DNlite independently predicted adverse kidney outcomes across both patients who received the drug canagliflozin and those who received placebo, even after accounting for conventional biomarkers. Rising protein levels corresponded with rising renal risk, a dose-response pattern that strengthens confidence in the finding.
The consistency across treated and untreated groups is particularly significant, as it suggests the biomarker addresses what researchers call residual renal risk — the danger that persists even in patients receiving optimal therapy. Senior author Ele Ferrannini, an emeritus investigator at Italy's National Research Institute of Clinical Physiology, had described this residual risk as a major unsolved challenge in diabetic kidney disease. He passed away shortly before the findings were presented, and the companies honored his contributions to the work.
The companies now describe DNlite as a next-generation diagnostic platform capable of refining how clinicians stratify kidney risk in diabetes care. Whether it ultimately changes patient outcomes depends on clinical validation, regulatory approval, and integration into real-world practice — the longer road that promising biomarkers must travel before they reach the bedside.
Two biotechnology companies presented findings this week at the American Diabetes Association's annual scientific conference that could change how doctors identify which diabetic patients face the highest risk of kidney failure. The research centers on a new blood test called DNlite, which measures a protein fragment in urine that conventional kidney tests have largely ignored.
The problem the test addresses is straightforward but consequential. Millions of people with type 2 diabetes develop chronic kidney disease, and even when doctors treat them with the latest medications—a class of drugs called SGLT2 inhibitors that have proven remarkably effective—many patients still experience progressive kidney decline. Doctors currently rely on two main measurements to assess kidney health: albuminuria, which detects protein leakage in urine, and eGFR, which estimates how well the kidneys filter waste. These measures work, but they don't capture the full picture. Some patients who look stable by these conventional standards continue to deteriorate. Others at apparent high risk remain stable. The result is a frustrating imprecision in risk assessment that leaves clinicians and patients uncertain about what comes next.
DNlite measures something these traditional tests miss: urinary post-translationally modified Fetuin-A, a protein that appears to reflect kidney stress, inflammation, and metabolic dysfunction. Bio Preventive Medicine Corp., based in Taiwan, and Precision Diabetes, Inc., based in North Carolina, analyzed data from 2,429 participants in the CREDENCE trial, a landmark international study that helped establish SGLT2 inhibitors as standard treatment for diabetic kidney disease. The researchers looked at baseline DNlite measurements in both patients who received the drug canagliflozin and those who received placebo, then tracked which patients experienced adverse kidney outcomes over time.
The findings were consistent across both groups. DNlite independently predicted which patients would experience kidney disease progression, even after accounting for albuminuria, eGFR, and other clinical variables. As the protein levels increased, so did renal risk—a dose-response relationship that strengthens confidence in the biomarker's validity. The test provided prognostic information that traditional markers alone could not supply. In other words, two patients might have identical albuminuria and eGFR readings, but their DNlite levels could tell a different story about their actual risk.
Karen Tseng, CEO of Bio Preventive Medicine, described the finding as evidence that DNlite captures "a unique aspect of kidney stress biology" that conventional tests overlook. Ele Ferrannini, an emeritus investigator at Italy's National Research Institute of Clinical Physiology and senior author of the analysis, called the result significant because residual renal risk—the danger that persists even in treated patients—remains "a major challenge" in diabetic kidney disease. The consistency of the findings across both treated and untreated populations suggests the biomarker's relevance is not limited to a particular subgroup.
Ferannini passed away shortly before the presentation of these findings, and the companies honored his contributions to the research. His death underscores the urgency of the work: diabetic kidney disease remains a leading cause of end-stage renal disease and dialysis initiation, and better tools for identifying high-risk patients could prevent or delay that progression.
The companies now position DNlite as a next-generation diagnostic platform that could refine how clinicians stratify renal risk in diabetic patients and identify those who need more aggressive monitoring or additional interventions. If the test gains clinical validation and regulatory approval, it could become part of routine kidney disease assessment in diabetes care. The question now is whether this laboratory finding translates into improved patient outcomes in real-world practice—and whether the test can be integrated into clinical workflows in a way that actually changes how doctors manage their patients.
Citas Notables
DNlite reflects a unique aspect of kidney stress biology that is not fully captured by traditional renal markers alone— 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— Ele Ferrannini, Emeritus Investigator of the National Research Institute of Clinical Physiology
La Conversación del Hearth Otra perspectiva de la historia
Why does this matter if we already have SGLT2 inhibitors? Aren't those drugs solving the problem?
They've helped enormously, but they haven't solved it. Many patients still lose kidney function despite being on these drugs. The real problem is we can't tell which patients are in that group until it's too late. This test might let us identify them earlier.
So it's about prediction—knowing who to watch more closely?
Exactly. Right now a doctor sees two diabetic patients with identical standard kidney test results and has no way to know that one is heading toward dialysis and the other will stay stable for years. DNlite could reveal that difference.
What is this protein it's measuring? Is it something new?
The protein itself isn't new. What's new is that someone realized this particular modified form of it—the version that appears in urine—tells you something important about kidney stress that the standard tests miss. It's like finding a different vital sign.
How confident should we be in this? It's one analysis of one trial.
Fair question. The strength here is that the pattern held up in both the treated and untreated groups within the same trial. That consistency matters. But you're right—this needs validation in other populations before it becomes standard practice.
If it works, what changes for patients?
Potentially, more frequent monitoring for high-risk patients, earlier interventions, maybe different medication choices. The goal is to catch decline before irreversible damage happens. For some people, that could mean avoiding dialysis altogether.