Company profile

Renalytix

Clinical Trials & ResearchPublic stage

Company profile

About Renalytix

Renalytix is focused on transforming kidney disease care with AI-powered solutions like KidneyIntelX, which provides data-driven insights for clinical teams.

Company description Renalytix official website

Primary marketClinical Trials & Research
Commercial modelCommercial information available on request
Company presenceLinkedIn X
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01 · Operating footprint

Where the Company operates

Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.

Clinical focus

  • Cardiovascular-kidney-metabolic (CKM) complications
  • Chronic kidney disease (CKD) stages 1-3b
  • Diabetic kidney disease
  • Type 2 diabetes with CKD

Who it serves

  • Cardiologists
  • Endocrinologists
  • Health Systems
  • Nephrologists
  • Payers
  • Primary care providers
  • Providers

Deployment & integration

Hybrid deployment with recorded integration context.

Recorded integration context: Clinical laboratory systems, Electronic Health Records (EHR).

Geographic context

MarketsUnited States
Company sourceOfficial website

Company milestones

Platform expansion

FDA marketing authorization Q2 2023, Medicare coverage determination June 2024, partnership with Carna Health announced May 2026 for population-scale CKD management

Partnerships

Recorded partners

  • AstraZeneca
  • Carna Health
  • Mount Sinai
  • National Kidney Foundation
  • Singing River Health System
  • University of Michigan

02 · Flagship portfolio

Products, workflows, and platform capabilities

Selected source-backed Company products and the available commercial context.

kidneyintelX.dkd

AI-enabled blood test predicting kidney function decline risk in diabetic kidney disease patients

Software · HybridCompany source

03 · Research intelligence

Research Intelligence evidence

Publications, preprints, clinical validation, and regulatory records in Evidence Position order.

Evidence position

Publications, clinical validation, and regulatory records connected to this Company appear here.

Research

Publications & preprints

Real-World Associations of KidneyIntelX Risk Stratification With Guideline-Directed Therapy, Kidney Outcomes, and Metabolic Trajectories in Early Diabetic Kidney Disease.

Diabetes, obesity & metabolism · Jun 28, 2026

Cost-effectiveness analysis of a prognostic risk assessment for early-stage 1-3b diabetic kidney disease patients in the United States.

Cost effectiveness and resource allocation : C/E · Jun 24, 2026

Baseline Risk and Longitudinal Changes in kidneyintelX.dkd and Its Association With Kidney Outcomes in the CANVAS and CREDENCE Trials.

Diabetes care · Jan 1, 2026

A Real-World Precision Medicine Program Including the KidneyIntelX Test Effectively Changes Management Decisions and Outcomes for Patients With Early-Stage Diabetic Kidney Disease.

Journal of primary care & community health · Jan 1, 2024

Derivation and independent validation of kidneyintelX.dkd: A prognostic test for the assessment of diabetic kidney disease progression.

Diabetes, obesity & metabolism · Dec 1, 2023

A Post Hoc Analysis of KidneyIntelX and Cardiorenal Outcomes in Diabetic Kidney Disease.

Kidney360 · Sep 29, 2022

Clinical validation

Clinical-trial records

Decision Impact Trial of KidneyIntelX

NCT04791358 · Sponsor · ACTIVE NOT RECRUITING

Real World Evidence Clinical Utility Study of KidneyIntelX

NCT04802395 · Sponsor · RECRUITING

Prospective Decision Impact Trial of KidneyIntelX

NCT04960514 · Sponsor · ACTIVE NOT RECRUITING

Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

NCT05198284 · Sponsor · ACTIVE NOT RECRUITING

Regulatory

Regulatory records

KidneyIntelX.dkd

DEN200052 · De Novo · Jun 29, 2023

04 · Company-reported outcomes

Outcomes and case studies

Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.

72% relative improvement in risk identification

vs standard-of-care markers (eGFR and UACR) alone

4.5X increase in SGLT2 inhibitor prescriptions

for high-risk patients identified by test

2.49X increase in specialist referrals

for high-risk vs low-risk patients

HbA1c reduction from 8.3 to 7.5%

in higher risk patients using KidneyIntelX technology

10-20% reduction in UACR levels

in higher risk patients

Increase from 33% to 61% meeting target metrics

at 12-month mark

Mount Sinai Health System

Risk stratification and guideline-directed therapy optimization for diabetic kidney disease patients

SGLT2 inhibitor use reached 70% in high-risk patients; 29% of retested patients moved to lower risk category; 43% improvement in eGFR decline rate over 2 years

Wake Forest/Atrium Health

Real-world evidence study for kidney disease risk stratification in type 2 diabetes patients with early-stage CKD

Part of 2,470 patient study showing sustained risk-stratified improvements; combination SGLT2i and GLP-1 RA therapy nearly tripled from 12% to 32%

Clinical validation study cohort

HEDIS metric improvement in high-risk diabetic kidney disease patients

HbA1c levels declined from 8.3 to 7.5%; UACR levels reduced by 10-20%; patients meeting target metrics increased from 33% to 61% at 12-month mark

Mount Sinai

Risk stratification for diabetic kidney disease patients to enable targeted treatment and specialist referrals

High-risk patients 4.5X more likely to be prescribed SGLT2 inhibitors; 2.49X more likely to be referred to specialists

Singing River Health System

Implementation of kidneyintelX.dkd for early-stage diabetic kidney disease management

University of Michigan

Clinical validation and implementation of kidney disease risk stratification using molecular mechanisms and patient data

05 · Leadership

Leadership team

Leadership profiles and professional links from the current Company record.

Elise Wilfinger

Elise Wilfinger

Chief Strategy & Marketing Officer

LinkedIn

Dr. Aida Vega

Associate Professor of Medicine, Director of Mount Sinai Faculty Practice Associates Primary Care Program

Dr. David Lam

Co-Principal Investigator, Endocrinologist

Dr. Joji Tokita

Co-Principal Investigator, Nephrologist

Prof. Matthias Kretzler

Warner-Lambert/Parke-Davis Professor of Medicine

Joseph Vassalotti

Chief Medical Officer, National Kidney Foundation

Tarek Rabah

Vice President of U.S. Renal-Cardio, AstraZeneca

Graham Dyer

Author/Communications

06 · Company updates

Updates from Renalytix

Recent articles published on Renalytix's official website.

07 · HAIC coverage

Coverage and analysis

Health AI Central reporting that mentions this Company.

No HAIC coverage is currently linked to this Company.

08 · Official presence

Company sources and channels

Curated official destinations from the active Company record.

09 · Market pathway

Additional Companies in this Market

Other active Companies in the same market, selected alphabetically from the HAIC directory.

Market context

Clinical Trials & Research

Companies using AI to optimize clinical trial design, accelerate patient recruitment, match patients to trials, predict trial outcomes, or improve clinical research efficiency. Includes patient enrollment and screening platforms, AI-powered trial matching, and tools that reduce the time and cost of bringing new treatments to market.

Explore the full market directory or compare this Company with additional active profiles.

View all Companies in this market

10 · Pro research

Coming soon

Expanded Company research is in development.

Health AI Central Pro · Coming Soon

Deeper Company research is coming soon.

Pro Research will introduce expanded technical context, linked evidence analysis, and comparative Company research.

ResearchEvidence analysis

Linked research, clinical, and regulatory source pathways.

CompanyTechnical context

Expanded product, deployment, integration, and partnership research.

MethodSource & review record

Record-level provenance and review context.

Coming Soon