Renalytix AI

What Renalytix AI does

Renalytix AI is a precision medicine diagnostics company that develops and commercializes prognostic blood tests for chronic kidney disease, with its lead product KidneyIntelX.dkd targeting patients with type 2 diabetes and early-stage CKD. The test is built on a proprietary machine learning algorithm that combines licensed blood-based biomarkers (sourced from Mount Sinai and Joslin Diabetes Center IP) with structured electronic health record data to produce a risk score for progressive kidney function decline over a five-year horizon. Clinical validation studies reported a 72% improvement in predictive performance compared with standard-of-care biomarker assessment, and the test has been authorized by the FDA via the De Novo pathway.

The company operates a B2B diagnostics model, primarily selling to enterprise health systems (including Mount Sinai, University of Michigan, Singing River Health System, New York Kidneys and Hypertension Medicine, and Veterans Affairs facilities) at a Medicare-reimbursed price of $950 per test. A secondary revenue stream comes from pharmaceutical services partnerships with life sciences companies such as AstraZeneca, supporting clinical trial enrichment and biomarker-driven drug development. Renalytix is headquartered in the UK with US operations, transferred its listing from Nasdaq to OTCQB in October 2024 to lower G&A costs, and is expanding commercially through partnerships (Carna Health, Tempus AI), a CE mark application for European Union entry, and engagements with European diabetes research centers including Steno Diabetes Center.

Name

Renalytix AI

Legal name

Renalytix plc

Website

https://renalytix.com

Company type

Public

Founded year

2018

Operating status

Operating

Headcount range

51–100 employees

Short description

Renalytix AI is a precision medicine diagnostics company that commercializes KidneyIntelX.dkd, an FDA-authorized, Medicare-reimbursed blood test using proprietary ML and biomarkers to predict kidney disease progression in type 2 diabetes patients, sold to health systems and pharma partners.

Ownership category

akta.pro rank

Product category

Clinical Diagnostics - Kidney Disease Prognostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), Medical and Diagnostic Laboratories (62151)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Renal Diagnostics & Monitoring (eGFR/Creatinine POC, Urine Analyzers, BP/Fluid Status) (HLAHAKAJ)

akta.pro secondary industries

Kidney & Dialysis Remote Care (CKD/ESRD monitoring, home dialysis support) (HLALAFAC), Diabetes Digital Therapeutics & Dose Decision Support (Bolus Calculators) (HLAHAHAJ)

Keywords

• AI-enabled diagnostics
• Kidney disease prognosis
• In vitro diagnostics
• Clinical decision support
• Bioprognostic testing

Headquarters

HQ city

Vale of Glamorgan

HQ country

United Kingdom

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Operations, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. Testing Services Revenue: Revenue generated from KidneyIntelX diagnostic testing services performed on patient blood samples. Each individual test is a performance obligation satisfied at a point in time upon completion of the testing process when results are reported. Revenue recognized at $950 per reportable result for Medicare patients.
2. Pharmaceutical Services Revenue: Revenue from analytical services provided to pharmaceutical companies, including feasibility studies to determine the impact of using KidneyIntelX platform to optimize utilization of CKD agents. Includes collaborations with AstraZeneca and other pharmaceutical partners.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels6 records

Core offering

Renalytix sells KidneyIntelX.dkd, an FDA-authorized, Medicare-reimbursed prognostic blood test that uses a proprietary machine-learning algorithm combining proprietary blood-based biomarkers with EHR clinical data to predict 5-year progressive kidney function decline in adult patients with type 2 diabetes and CKD stages 1-3b, generating low/moderate/high risk scores that clinicians use to target treatment. The company also operates a CLIA-certified clinical laboratory in New York, a physician ordering portal (MyIntelX), pharmaceutical services for CKD drug development partners such as AstraZeneca, and the Well Filtered education platform.

Product overview

Renalytix is an AI-enabled in vitro diagnostics company offering a unified product ecosystem centered on kidney disease prognosis. The core offering is KidneyIntelX.dkd, an FDA-approved and Medicare-reimbursed prognostic test that uses a proprietary machine-learning algorithm combining blood-based biomarkers with EHR data to predict kidney disease progression in type 2 diabetes patients. This is complemented by the MyIntelX physician ordering portal for test access, Pharmaceutical Services for drug development partnerships, and the Well Filtered education platform. The KidneyIntelX Platform serves as the expandable technology foundation for current and future diagnostic applications in kidney health management.

Differentiator

Problem solved

Functional benefit

Brands

• KidneyIntelX: FDA-approved AI-enabled diagnostic test for predicting progressive decline in kidney function in patients with type 2 diabetes and early-stage chronic kidney disease (stages 1-3b). Also referred to as kidneyintelX.dkd.
• KidneyIntelX.dkd
• bioprognosis

Products and services

• KidneyIntelX.dkd FDA-authorized and Medicare-reimbursed prognostic blood test that uses a proprietary machine-learning algorithm combining proprietary blood-based biomarkers with EHR clinical data to predict progressive decline in kidney function over 5 years in adult patients with type 2 diabetes and CKD stages 1-3b, generating a low/moderate/high risk score for clinicians to guide targeted treatment.
• KidneyIntelX Platform Expandable AI-enabled diagnostic platform based on Mount Sinai-licensed technology that uses machine learning to process predictive blood biomarkers with patient health record data for kidney health risk scoring, designed for FDA-regulated, insurance-reimbursable applications with potential for additional indicated uses and monitoring capabilities.
• MyIntelX Portal Physician ordering and results portal that enables primary care and specialist physicians to order KidneyIntelX testing and access patient risk results electronically.
• Pharmaceutical Services

Quantifiable outcome

• 4.5x increase in SGLT2 inhibitor prescriptions for high-risk vs. low-risk patients
• +5 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability2 records

Feature3 records

Partnerships

Eleven partnerships are on record, tiered flagship, core and minor.

• Carna HealthflagshipStrategic or Co-development Partner · 12 May 2026Landmark partnership to integrate FDA-approved kidneyintelX.dkd diagnostic test with Carna Health's AI-driven digital CKD prevention and management platform. The collaboration aims to enable earlier, risk-guided interventions for patients with type 2 diabetes and early-stage CKD, reduce catastrophic 'crash' dialysis starts, and address the $130 billion annual Medicare CKD spending burden. Carna Health projects screening 1 to 1.5 million additional lives globally by year-end.
• Tempus AIcoreTechnology or Integration · 21 September 2025Collaboration to expand kidneyintelX.dkd test access in the US by integrating with Tempus AI's data and analytics platform. The partnership aims to advance intelligent risk assessment in diabetic kidney disease through enhanced data capabilities and provider reach.
• New York Kidney & Hypertension Medicine (NYKHM)coreStrategic or Co-development Partner · 3 June 2025Collaboration to expand kidneyintelX.dkd testing to underserved, high-risk communities in the Greater New York area, including Queens and Brooklyn. The program enables access for over 2,000 patients and includes community-based provider education and patient awareness initiatives.
• EVERSANAcoreChannel Partner/ Reseller/ DistributorCommercialization partnership to expand deployment of KidneyIntelX across key U.S. regions with high rates of diabetic kidney disease and established insurance coverage. EVERSANA provides commercial infrastructure and market access capabilities.
• Mount Sinai Health SystemcoreStrategic or Co-development PartnerLong-term partnership with Mount Sinai Health System for KidneyIntelX testing and real-world evidence generation. Includes technology license from Icahn School of Medicine at Mount Sinai. Mount Sinai faculty members are co-founders and equity owners in the company.
• DaVita Inc.minorImplementation/ SI/ Consulting PartnerMaster Care Coordination Services Agreement for care coordination services for covered patients identified by KidneyIntelX diagnostic. DaVita provides monthly care coordination at $10 per covered patient plus $3.50 for patient engagement services.
• AstraZenecacoreStrategic or Co-development PartnerPharmaceutical services collaboration including feasibility study to determine impact of KidneyIntelX platform on optimizing utilization of CKD agents. Multiple statement of work agreements and master service agreement for future pharmaceutical collaborations.
• Veterans AdministrationcoreStrategic or Co-development PartnerAgreement to integrate KidneyIntelX solution within VA Health System's cloud infrastructure and interface with VA electronic health record systems. Enables providers at VA Medical Centers and outpatient clinics to order and receive test results seamlessly.
• Steno Diabetes CenterminorStrategic or Co-development PartnerPrecision medicine collaboration marking first expansion of KidneyIntelX platform beyond the US, extending into international markets through Steno's diabetes care network.
• PRIME-CKD ConsortiumcoreStrategic or Co-development Partner$10 million Horizon Europe Grant consortium to advance personalized medicine in treating chronic kidney disease. Validates and implements novel biomarker-based tests that predict response to existing CKD drugs. Approximately 10% of budget targeted for commercial translation activities.
• National Kidney FoundationminorGTM or Marketing PartnerWorld-class partner organization for kidney health awareness and advocacy. Featured partner in company's growing roster of collaborations to change lives of CKD patients.

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Verici Dx: Verici Dx is a clinical-stage diagnostics company developing RNA-based and AI-enabled tests for kidney transplant rejection and kidney injury. Comparable to Renalytix as a small, public, AI-driven specialty kidney diagnostics company targeting nephrology.

Emerging players

• Carna Health: Carna Health is an AI-enabled digital health company focused on chronic disease prevention, with a flagship platform for CKD screening and management. Direct commercial partner of Renalytix, addressing the same CKD risk stratification use case via digital-first population screening rather than a lab test.
• ProKidney: ProKidney is a clinical-stage cell-therapy company focused on CKD and diabetic kidney disease. While operating in a different modality (cell therapy vs. diagnostics), it is a comparably sized, publicly traded CKD-focused company addressing the same T2D-driven kidney disease patient population.

Broad incumbents

• Tempus AI: Tempus AI is a larger AI-driven precision medicine company offering data, analytics, and diagnostics across oncology and beyond. Renalytix's collaboration partner; competes broadly in AI-enabled specialty diagnostics and provides a distribution/analytics platform that KidneyIntelX integrates into.
• DaVita: DaVita is the largest US provider of kidney dialysis services and integrated kidney care. Renalytix has a Master Care Coordination Services Agreement with DaVita; both serve the same CKD/ESRD patient population, though DaVita's core business is dialysis services rather than prognostic diagnostics.
• Quest Diagnostics: Quest Diagnostics is one of the largest US clinical laboratory networks offering a broad menu of routine and specialty diagnostics. Comparable as a high-scale reference lab channel that could potentially commercialize or compete with AI-enabled CKD prognostic testing at far greater distribution breadth.
• Laboratory Corporation of America (Labcorp): Labcorp is a global clinical laboratory and diagnostics company with extensive specialty testing capabilities and nationwide physician access. Relevant comparable for the KidneyIntelX clinical lab operating model and as a potential channel or competitor for AI-enabled CKD tests.
• Exact Sciences: Exact Sciences is a larger commercial-stage diagnostics company with Cologuard and Oncotype products, known for building AI/ML-enabled screening tests with established reimbursement and direct-to-physician sales forces. Comparable in business model (specialty IVD with ML components) and a potential long-term competitive threat in CKD screening.
• Natera: Natera is a specialty genetics and molecular diagnostics company with a large commercial sales force and established reimbursement infrastructure across oncology, women's health, and organ health. Comparable as a high-growth AI-enabled specialty diagnostics player that has expanded from one indication into adjacent organ-disease testing.
• Veracyte: Veracyte is a genomic diagnostics company developing tests across urology, thyroid, and lung using RNA sequencing and ML. Comparable as a specialty IVD business built on proprietary molecular assays and machine learning algorithms sold through physician channel sales.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights8 records

Customer concentration

• Xx.com/Renalytix
• LinkedInlinkedin.com/company/renalytixai

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries2 records

Funding overview

Funding rounds8 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Renalytix AI