Renalytix teams up with Tempus AI to scale kidneyintelX.dkd across US health systems
Renalytix has signed a collaboration agreement with Tempus AI to make its kidneyintelX.dkd test more widely available across Tempus’s US network of healthcare institutions. This is a strategic distribution move aimed at getting the only FDA-approved and Medicare reimbursed prognostic test for early-stage chronic kidney disease risk assessment in front of far more clinicians and eligible patients.
The focus is clear: earlier risk stratification in chronic kidney disease for people with type 2 diabetes, where timely intervention can slow progression and reduce complications. For a small-cap diagnostics company, plugging into a large US technology-enabled network is a meaningful catalyst.
What exactly was announced in the RNS?
Renalytix and Tempus AI have entered a collaboration to expand access to kidneyintelX.dkd within Tempus’s US network. The test will be the first in Tempus’s chronic kidney disease category and is indicated to predict risk level – high, moderate or low – for progressive decline in kidney function in patients with type 2 diabetes and diagnosed chronic kidney disease stages 1 to 3b.
Eligible patients number nearly 15 million in the US, a sizeable target population for a reimbursed, guideline-recommended tool that fits into routine care.
Who benefits and how the test is used
kidneyintelX.dkd is designed for people with type 2 diabetes and chronic kidney disease at stages 1-3b. The test provides a risk score to guide care decisions earlier in the disease course, when treatment impact is greatest. According to Renalytix, the test has FDA approval and Medicare reimbursement, and is recommended for use in international chronic kidney disease clinical guidelines (KDIGO).
Operationally, tests will be processed in a Renalytix laboratory. Customised results will be delivered electronically to clinicians and, where applicable, patient portals. The goal is to integrate ordering within existing clinical workflows, making it straightforward for providers to adopt.
Why this collaboration matters for investors
- Distribution boost: Tempus operates a large US network with broad clinical reach. Being the first CKD test in their portfolio gives kidneyintelX.dkd a clear lane.
- Reimbursed and approved: Medicare reimburses at $950 per reportable result, and the test has FDA approval, removing two major barriers to scale.
- Evidence base: Over 15,000 patients have been tested, generating real-world performance data and showing significant increases in diagnosis, prognosis and treatment rates where deployed.
- Guideline support: Recommendation in KDIGO guidelines should help clinician adoption and payer acceptance.
- Data flywheel: The collaboration emphasises multi-modal data accumulation and analysis in cardio-renal-metabolic patients, which can drive further diagnostic and therapeutic innovation.
Commercial and operational takeaways
Keeping testing in-house at Renalytix’s lab means the company should maintain direct control over quality and reporting while benefiting from the Medicare rate of $950 per reportable result. Integration into existing clinical workflows via Tempus can be the difference between a good test and a widely used one, especially in primary and specialty care settings managing diabetes and kidney disease.
| Key metric | Detail |
|---|---|
| Eligible US patients | Nearly 15 million (type 2 diabetes with CKD) |
| Test status | FDA approved and Medicare reimbursed |
| Reimbursement | $950 per reportable result (Medicare) |
| Indication | Risk prediction for CKD progression in stages 1-3b |
| Real-world use | Over 15,000 patients tested to date |
| Guidelines | Recommended by KDIGO |
| Disease scale | Over 14 million affected in the US; 8 million in the UK |
What Tempus brings to the partnership
Tempus is a technology company advancing precision medicine with artificial intelligence, underpinned by one of the world’s largest libraries of multimodal data and an operating system designed to make that data actionable. For Renalytix, this means access to a scaled clinical footprint and an AI-enabled platform that can surface insights for clinicians at the point of care, while facilitating discovery and development in parallel.
Notably, kidneyintelX.dkd becomes Tempus’s first offering in the chronic kidney disease category, signalling a strategic expansion by Tempus into diabetes and CKD and giving Renalytix a prominent position within that category from the outset.
Management’s commentary in brief
Renalytix’s CEO James McCullough highlighted Tempus’s broad clinical reach and the expectation that the partnership will accelerate access to precision medicine testing and drive innovation through multi-modal data. Tempus COO Ryan Fukushima underscored a shared mission of using AI-enabled diagnostics to inform care, and the expansion into diabetes and chronic kidney disease.
The balanced view: what is and is not disclosed
There is plenty to like: a first-in-category position within Tempus, clear clinical need, and reimbursement in place. The test is already FDA approved and supported by real-world data and KDIGO guidance. All supportive for adoption.
However, several commercial details are not disclosed:
- Financial terms or revenue sharing – not disclosed.
- Exclusivity, duration, and any volume commitments – not disclosed.
- Specific rollout timelines or the number of initial sites going live – not disclosed.
- Any incremental costs to Renalytix for scaling lab capacity or integration – not disclosed.
In other words, the strategic direction is positive, but investors will need future updates to gauge the pace and magnitude of uptake.
Why this could be a catalyst
Chronic kidney disease in type 2 diabetes is prevalent, costly, and often under-recognised. A prognostic test that is FDA approved, reimbursed, and now embedded into a major clinical tech platform has a realistic pathway to increased ordering. If Renalytix converts Tempus’s reach into meaningful test volumes, the combination of reimbursement and centralised processing could be impactful.
The data angle matters too. As more patients are tested, the evidence base grows, which can reinforce clinical confidence, guideline support, and payer coverage. The RNS explicitly points to multi-modal data accumulation across cardiovascular, renal and metabolic patients – a sensible focus area for future products and collaborations.
What to watch next
- Operational rollout: confirmation of participating health systems and go-live milestones.
- Uptake indicators: order rates, repeat ordering behaviour, and clinician adoption within Tempus’s network.
- Payer mix: continued traction with Medicare and potential broadening of coverage beyond Medicare.
- Outcomes evidence: additional real-world data publications on risk stratification and treatment optimisation.
- Commercial terms: any disclosure on economics, duration, or exclusivity of the collaboration.
Bottom line
This is a strategically strong move by Renalytix. It aligns an FDA-approved, Medicare reimbursed test with a scaled AI-enabled clinical platform, directly tackling a large and costly disease area. The lack of disclosed commercial terms means we cannot model the financial impact yet, but the ingredients for adoption – reimbursement, workflow integration, guideline support, and a clear patient benefit – are all present.
Net positive for the story, with execution now the key driver. Watch for concrete rollout metrics and early indicators of ordering momentum within Tempus’s network.
