Renalytix AI
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.
- Company typePublic
- Founded2018
- HeadquartersVale of Glamorgan, United Kingdom
- Headcount51–100
- GTM typeB2B
- OfferingSoftware
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.
Renalytix AI firmographics
Firmographics- 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
Renalytix AI industry classification
Industry- 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
Where Renalytix AI is headquartered
LocationHeadquarters
- HQ city
- Vale of Glamorgan
- HQ country
- United Kingdom
- HQ region
- Europe
Offices3 records
Markets served
Renalytix AI business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Operations, Personnel, Marketing or Sales, Infrastructure
Revenue model
- 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.
- 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
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | $950 per reportable result for Medicare |
| Unit Pricing | Pay-as-you-go | Commercial insurance reimbursement |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels6 records
Renalytix AI product offering
Product offeringCore 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
Companies that use Renalytix AI
Customer profileNamed customers5 records
Segments5 records
Ideal customer profiles2 records
Renalytix AI technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration3 records
AI capability2 records
Feature3 records
Renalytix AI partnerships and signals
Strategic signalPartnerships
Eleven partnerships are on record, tiered flagship, core and minor.
- Carna HealthflagshipLandmark 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 AIcoreCollaboration 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)coreCollaboration 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.
- EVERSANAcoreCommercialization 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 SystemcoreLong-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.minorMaster 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.
- AstraZenecacorePharmaceutical 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 AdministrationcoreAgreement 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 CenterminorPrecision medicine collaboration marking first expansion of KidneyIntelX platform beyond the US, extending into international markets through Steno's diabetes care network.
- PRIME-CKD Consortiumcore$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 FoundationminorWorld-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
Renalytix AI competitors and assessment
Company assessmentDirect 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
Renalytix AI social profiles
Digital presenceRenalytix AI compliance and trust
Trust signalCompliance3 records
Renalytix AI financial estimates
Financial estimateRevenue estimate
Valuation estimate
Renalytix AI leadership team
Management profileNumber of profiles
Profiles9 records
Renalytix AI subsidiaries and ownership
Company hierarchySubsidiaries2 records
Renalytix AI funding detail
Funding detailFunding overview
Funding rounds8 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Renalytix AI M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Renalytix AI
What does Renalytix AI do?
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.
Is Renalytix AI a public or private company?
Renalytix AI is a public company. It is classified as public and is currently operating.
When was Renalytix AI founded?
Renalytix AI was founded in 2018. It employs 51 to 100 people.
Where is Renalytix AI based?
Renalytix AI is headquartered in Vale of Glamorgan, United Kingdom, in the Europe region.
How does Renalytix AI make money?
Two revenue lines are on record. Testing Services Revenue is the primary driver. The others are pharmaceutical Services Revenue.
Who are Renalytix AI's main competitors?
Verici Dx is listed as a direct peer. Emerging players are Carna Health and ProKidney. Broad incumbents are Tempus AI, DaVita, Quest Diagnostics, Laboratory Corporation of America (Labcorp), Exact Sciences, Natera and Veracyte.
Does Renalytix AI have an API?
No public API is recorded for Renalytix AI.
What industry is Renalytix AI in?
Renalytix AI's product category is Clinical Diagnostics - Kidney Disease Prognostics. Its primary akta.pro industry code is HLAHAKAJ, Renal Diagnostics & Monitoring (eGFR/Creatinine POC, Urine Analyzers, BP/Fluid Status), with a secondary code of HLALAFAC, Kidney & Dialysis Remote Care (CKD/ESRD monitoring, home dialysis support). Its NAICS code is 621511 and its SIC code is 8071.