Argeron NephroTesT® Kidney Biomarker Platform

Early Insight Into Kidney Injury

A patented urinary trehalase biomarker platform for proximal tubular stress.

Argeron NephroTesT® is a patented urinary trehalase activity platform designed to support early scientific and clinical insight into proximal tubular stress using practical laboratory infrastructure. It transforms decades of urinary trehalase research into a scalable biomarker approach for kidney injury assessment across hospitals, clinical laboratories and research settings.

Patented TechnologyCE MarkedUrine-Based BiomarkerStandard Laboratory WorkflowProximal Tubular Stress Insight
Early Insight Into Kidney Injury
The Clinical Need

AKI is common, costly and often detected too late.

Acute kidney injury is a common and life-threatening condition in hospital and intensive care settings. Current literature reports that AKI may affect approximately 20% of general ward patients and up to 50% of ICU patients. In patients requiring renal replacement therapy, mortality can exceed 50%.

Despite this burden, AKI may remain under-recognized in real-world hospital care. A 2025 systematic review of AKI clinical practice guidelines reported that 68% of in-hospital AKI cases remained undiagnosed, correlating with 21.1% mortality, compared with 3.8% mortality in non-AKI patients.

~20%Reported AKI incidence among general ward patients
Up to 50%Reported AKI incidence among ICU patients
68%Reported in-hospital AKI cases that may remain undiagnosed
21.1%Reported mortality associated with this diagnostic gap
The need is clear: earlier, practical and scalable biomarker insight for kidney injury risk.
AKI is common, costly and often detected too late.
The Solution

The Argeron NephroTesT® solution

Argeron NephroTesT® focuses on urinary trehalase activity, a proximal tubular brush-border enzyme signal investigated for decades in kidney injury research. By translating urinary trehalase activity into a practical and patented laboratory-compatible platform, NephroTesT® is designed to support earlier biomarker-based insight into renal tubular stress.

1

Proximal Tubule Focus

Targets one of the earliest and most vulnerable sites of kidney injury.

2

Urinary Trehalase Activity

Builds on decades of scientific literature on renal tubular damage.

3

Standard Laboratory Compatibility

Designed for practical integration into routine laboratory workflows.

4

Patented Biomarker Platform

Transforms a known biological signal into a scalable testing approach.

5

Clinical Evidence Pathway

Supported by published and emerging studies across multiple kidney stress settings.

The Argeron NephroTesT® solution
Measurement & Evidence

Clinical & analytical performance

From urinary trehalase biology to measurable kidney injury insight.

Argeron NephroTesT® is designed to convert urinary trehalase activity into a practical laboratory result that can support biomarker-based evaluation of proximal tubular stress. The platform is developed to work with standard urine glucose testing infrastructure and to provide a scalable workflow for clinical laboratories, hospitals and research centers.

Clinical & analytical performance

Pediatric Dehydration-Related AKI Evidence

Emerging evidence

A prospective controlled pediatric preprint evaluated urinary trehalase and urinary trehalase/creatinine ratio in children presenting with acute dehydration. The study included 80 dehydrated children and 40 healthy controls. Within the dehydrated cohort, children with AKI had higher urinary trehalase and higher trehalase-to-creatinine ratio than those without AKI.

  • Reported AUC: 0.925
  • Reported specificity: 100% at cut-off >9.55 mg/dL
  • View Full Study
Urine-BasedNon-invasive sample workflow
Proximal Tubule SignalFocus on tubular stress before late functional decline
Standard Lab CompatibleDesigned for existing urine glucose testing infrastructure
Two-Reading Differential WorkflowPractical measurement approach for trehalase activity
Scalable PlatformSuitable for clinical laboratories and translational research

Contrast-Associated AKI Study

Published clinical evidence

A 2023 clinical study evaluated urinary trehalase activity in contrast-associated acute kidney injury. The study measured urinary trehalase before and after contrast exposure at 12, 24 and 48 hours and concluded that urinary trehalase activity can be useful as a marker of acute kidney injury due to proximal tubular damage.

  • 12h early post-contrast window
  • Reported ROC AUC: 0.776
  • Reported sensitivity: 88.9%
  • View Full Study
Scientific Foundation

Why the proximal tubule matters

The proximal tubule is one of the earliest and most vulnerable sites of kidney injury. Kidney injury may begin at the tubular level before conventional markers fully reflect functional decline.

Modern AKI and cardiovascular-kidney-metabolic health frameworks increasingly emphasize earlier recognition, prevention and biomarker-supported assessment rather than relying only on late-stage functional deterioration.

1

Proximal Tubule Biology

Renal tubular injury may precede detectable functional decline.

2

AKI-to-CKD Continuum

A single AKI episode can increase long-term risk of CKD, cardiovascular disease and mortality.

3

CKM Health Context

Kidney disease is deeply connected with metabolic and cardiovascular health.

4

Biomarker Need

Earlier tubular injury biomarkers may help close the recognition gap in AKI.

Why the proximal tubule matters
Clinical Scope

Clinical & research application areas

Argeron NephroTesT® is positioned as a urinary trehalase activity platform for biomarker-based insight into proximal tubular stress across multiple clinical and research settings.

Clinical & research application areas
1

Contrast-Associated AKI

Kidney stress evaluation after contrast-enhanced CT, angiography and interventional procedures.

2

Pediatric Dehydration-Related AKI

Research and clinical evaluation of renal tubular stress in children presenting with acute dehydration.

3

Emergency Medicine & Intensive Care

High-risk acute care settings where AKI may evolve rapidly.

4

Obstetrics & Women’s Health

Urinary trehalase has been investigated in pregnancy-related tubular dysfunction and toxemia of pregnancy.

5

Oncology & Nephrotoxicity

Potential use in renal tubular stress monitoring associated with nephrotoxic therapies.

6

Diabetes & Metabolic Kidney Stress

Earlier studies reported elevated urinary trehalase activity in maturity-onset diabetes.

7

Newborn & Pediatric Kidney Injury

Urinary trehalase has been reported as a marker of proximal tubular damage in newborn infants.

8

Toxic Nephropathy

Trehalase activity has been studied in lead and cadmium exposure-related kidney injury.

9

Chronic & Progressive Kidney Disease

Trehalase has been investigated in chronic glomerulonephritis and progressive kidney disease contexts.

10

Vasculitis-Associated Kidney Disease

Recent evidence reports urinary trehalase alongside NGAL as a noninvasive biomarker in ANCA-associated vasculitis outcome evaluation.

Evidence Timeline

Built on decades of trehalase and kidney injury research

Urinary trehalase has been investigated since the 1980s as a renal brush-border enzyme associated with proximal tubular damage. NephroTesT® translates this long-standing biomarker foundation into a patented and practical laboratory-compatible platform.

Built on decades of trehalase and kidney injury research
1976
Baseline Urinary Enzyme Excretion
Normal limits of urinary excretion of eleven enzymes established early clinical chemistry context for urinary enzyme assessment.
1986
Cadmium Exposure & Brush-Border Damage
Urinary trehalase activity investigated in inhabitants of a cadmium-polluted area.
1986–1987
Pregnancy-Related Tubular Dysfunction
Urinary trehalase investigated in normal pregnancy and toxemia of pregnancy.
1987
Diabetes-Related Kidney Stress
Elevated urinary trehalase and maltase activities reported in maturity-onset diabetes mellitus.
1988
Environmental Cadmium Kidney Injury
Urinary trehalase activity studied as an indicator of kidney injury due to environmental cadmium exposure.
1993
Chronic Glomerulonephritis
Urinary trehalase activity investigated in chronic glomerulonephritis.
1995
Newborn Proximal Tubular Damage
Urinary trehalase activity reported as a marker of renal proximal tubular damage in newborn infants.
1996
Human Trehalase Localization
Human trehalase characterized and associated with increased urinary levels after renal proximal tubular damage.
2000
Urinary Trehalase ELISA Method
ELISA-based urinary trehalase assessment developed for renal tubular damage evaluation.
2001
Occupational Lead Exposure
Urinary trehalase activity studied as an indicator of renal dysfunction in lead-exposed workers.
2023
Contrast-Associated AKI
Argeron-associated clinical study evaluated urinary trehalase activity in contrast-associated acute kidney injury.
2026 / Under Revision
Pediatric Dehydration-Related AKI
Emerging pediatric evidence evaluates urinary trehalase in dehydrated children with AKI risk.
2026
ANCA-Associated Vasculitis & ESKD Prediction
Urinary trehalase has been evaluated alongside NGAL for renal outcome prediction in ANCA-associated vasculitis.
Global Impact

A global health and economic challenge

Kidney disease creates a substantial clinical and economic burden worldwide. CKD is estimated to affect approximately 700–840 million people, with worldwide prevalence estimated at 8–14%. Costs increase sharply as disease progresses toward kidney failure and kidney replacement therapy.

A global review across 31 countries and regions reported mean annual per-patient costs of approximately $3,060 for CKD stage G3a, $57,334 for hemodialysis, $49,490 for peritoneal dialysis and $75,326 for the first year after kidney transplant. The same study estimated mean annual costs of $5,975 for AKI-related complications.

700–840MPeople estimated to be affected by CKD globally
$57,334Mean annual cost per hemodialysis patient
$49,490Mean annual cost per peritoneal dialysis patient
$5,975Mean annual cost of AKI-related complications
Earlier biomarker insight may support prevention-focused kidney care strategies, especially in settings where tubular injury can precede major changes in conventional kidney function markers.
A global health and economic challenge
Laboratory Workflow

Designed for practical laboratory integration

Designed for practical laboratory integration

Urine Sample

A urine sample is collected according to standard laboratory workflow.

Trehalase Activity Reaction

Urinary trehalase activity is evaluated using a patented reaction approach.

Glucose-Based Readout

The platform is designed for compatibility with standard urine glucose testing infrastructure.

Biomarker-Based Insight

Results support assessment of proximal tubular stress together with clinical findings and standard laboratory parameters.

This public website intentionally avoids disclosing formulation ratios, reagent details, calculation formulae or claim-level technical steps.

Validation

Recognition, milestones & market validation

Argeron NephroTesT® is part of Argeron’s broader life science innovation portfolio, combining patented biomarker technology, CE-marked product development, clinical evidence generation and early market traction. Argeron’s kidney biomarker innovation has been supported by scientific studies, healthcare innovation awards and recognition from national and international innovation platforms.

NephroTesT® Product Milestones

  • Patented urinary trehalase activity technology
  • CE-marked product development
  • Published 2023 contrast-associated AKI clinical study
  • Emerging pediatric dehydration-related AKI evidence
  • Early hospital and laboratory market traction

Argeron Innovation Recognition

  • TET Project Market — Türkiye’s Number One, 2022
  • Bayer G4A Türkiye — Health Category Winner, 2022
  • Hello Tomorrow Global — Deep Tech Pioneer Award, 2023
  • SASDER Innovation Competition — Türkiye’s Number One, 2025
  • AstraZeneca Türkiye AZ Lab — selected among 10 innovative startups, 2025
Recognition, milestones & market validation
Commercial Pathway

Built for scalable kidney biomarker adoption

1

For Hospitals

Supports earlier biomarker insight in high-risk kidney injury settings.

2

For Clinical Laboratories

Designed for standard workflow compatibility and scalable adoption.

3

For Clinicians

Provides adjunct biomarker information for renal tubular stress assessment.

4

For Research Centers

Enables translational studies in AKI, CKD and tubular injury biology.

5

For Distributors

A patented kidney biomarker platform with international scale potential.

6

For Pharma & Clinical Research

Potential biomarker support for nephrotoxicity monitoring and drug development studies.

Argeron NephroTesT® product platform
Product Platform

Argeron NephroTesT® product platform

Argeron NephroTesT® is developed as a urine-based trehalase activity testing platform designed for laboratory use. It supports biomarker-based evaluation of proximal tubular stress through a practical workflow compatible with standard urine glucose testing infrastructure.

Sample TypeUrine
BiomarkerUrinary trehalase activity
Biological FocusProximal tubular stress / injury
Readout PrincipleGlucose-based differential measurement
WorkflowLaboratory-compatible process
Regulatory PositioningCE-marked product development
Responsible Use

Safety and regulatory positioning note

Argeron NephroTesT® is intended to support biomarker-based scientific and clinical evaluation of renal tubular stress. It is not presented as a standalone diagnostic decision tool and should be interpreted together with clinical findings, standard laboratory parameters and physician assessment.

Partner with Argeron NephroTesT®

Bring early tubular stress insight into clinical laboratories, hospitals and kidney research programs.