Chat GPT 5. Direct output. Not proofed.
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Renalytix (Renalytix AI plc) is a diagnostics company focused on risk stratification in chronic kidney disease (CKD). Its lead product, KidneyIntelX.dkd, is an AI-enabled in-vitro diagnostic that combines clinical variables and blood biomarkers to predict risk of progressive decline in adults with diabetes and early CKD—positioning the test as a prognostic tool to guide care intensification, referrals, and medication management. The company’s strategy has been to secure U.S. regulatory authorization and payer coverage first, then drive clinical adoption at health systems with large diabetic CKD populations. Renalytix+1
Target market & go-to-market. Renalytix estimates a very large U.S. addressable population—patients with type 2 diabetes and early CKD—where earlier risk identification could reduce dialysis and hospitalization costs. The testing model is lab-based and priced as a covered diagnostic for appropriate patients once criteria are met. In June 2024, the company announced Medicare coverage and a national payment rate for KidneyIntelX.dkd (CPT 0407U, price $950), describing this alongside prior FDA authorization and outcomes publications as the prerequisites for broad adoption. Commercial execution has centered on integrated delivery networks and nephrology/endocrinology channels. Renalytix+2Yahoo Finance+2
Public listing. Renalytix listed in London on AIM (RENX) and later completed a U.S. IPO of American Depositary Shares on Nasdaq (RNLX) in July 2020, raising roughly $74 million. This was a traditional IPO (not a SPAC). Nasdaq+1
Regulatory milestone. On June 29, 2023, FDA granted De Novo marketing authorization (DEN200052) for KidneyIntelX.dkd as a Class II device (product code QWZ)—a key credibility marker in a field where many AI diagnostics remain LDTs. FDA Access Data
https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200052.pdf
Payers, cash flow, and operating challenges. Despite regulatory and coverage wins, Renalytix has struggled to convert these into material revenue. In FY2024 the company reported low sales and significant operating losses, with cash of ~$4.7M as of March 31, 2024, prompting cost cutting and small financings. It also faced Nasdaq compliance issues (minimum bid/market value) and requested a hearing following a staff delisting determination in mid-2024. Management has characterized FY2024 as a painful but necessary reorganization to align spend with a sales-led model post “regulatory/outcomes/reimbursement” milestones. Renalytix+2MarketWatch+2
Current state (major events?). As of late 2025, Renalytix continues to operate and issue investor updates; there is no public filing indicating bankruptcy or closure. The company has raised modest equity tranches (e.g., April 2024) while exploring strategic options, and it remains listed in the U.K. (RENX) with corporate news continuing to post. The overall picture is a going concern under financial pressure: FDA De Novo and Medicare coverage are in place, but payer uptake and scale remain the gating factors for sustainable cash flow. The Wall Street Journal+1
September 2025 - Raise Cash. $9M.
(BQ, TEMPUS) 9 2025 collaboration with TEMPUS. see below
Bottom line: Renalytix achieved what many AI diagnostics aspire to—De Novo authorization and Medicare coverage—yet still illustrates how commercial execution and payer adoption can lag regulatory success. For any early-detection or risk-stratification company, the Renalytix trajectory underscores the need to pair evidence and coverage wins with concentrated adoption programs, tight burn control, and clear economic stories for payers and health systems. Renalytix+1
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TEMPUS - ADD ON
Here’s a deeper summary of the collaboration between Renalytix AI plc (“Renalytix”) and Tempus AI, Inc. (“Tempus”) announced in September 2025 — plus analysis of what it signals (and what to watch).
What the deal is
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On 15 September 2025, Renalytix announced a definitive collaboration agreement with Tempus AI to make its prognostic blood-test, KidneyIntelX.dkd (for type 2 diabetes patients with chronic kidney disease stages 1–3b), more widely available within Tempus’s U.S. network of healthcare institutions. PR Newswire+2Renalytix Investors+2
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Key features:
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The test is FDA-authorized (De Novo) and Medicare-reimbursed. Investegate+2Joshua Thompson+2
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Eligible population: nearly 15 million U.S. patients with type 2 diabetes + CKD (approx). PR Newswire+1
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Under the deal: testing will be processed in Renalytix’s laboratory, and results delivered electronically to clinicians/patient portals; integration into existing clinical workflows via Tempus’s platform. Renalytix Investors+1
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KidneyIntelX.dkd will be the first chronic kidney disease (CKD)-category test in Tempus’s portfolio. Renalytix+1
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Partnership emphasises data and analytics: “multi-modal data accumulation and analysis in cardiovascular, renal and metabolic space.” Renalytix Investors+1
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Why this matters (sub-surface analysis)
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Distribution leverage: Renalytix has historically struggled with commercial scale (despite FDA & Medicare) due to limited reach; partnering with Tempus gives access to a bigger clinical/health-system network, which could help jumpstart ordering volume.
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Workflow & integration: Diagnostics adoption often lags because of ordering friction and workflow mis-fit. The mention of integrating into Tempus’s existing systems suggests an attempt to reduce that friction — a positive step.
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Data strategy: The collaboration signals that beyond just selling the test, Renalytix (and Tempus) want to build a “data flywheel”—collect multimodal data (clinical + genomic + biomarker) in the cardio-renal-metabolic space. This could broaden beyond the initial test into platform or downstream therapeutics.
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Validation of business model: For a diagnostics company with regulatory success but underwhelming commercial results, this deal helps validate that their test is fit for scale or at least that they are attempting scale. That can help in positioning for partnerships, payor negotiations, or future financing.
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Risk mitigation: From a strategy/advisory lens: this deal helps Renalytix mitigate the risk of “standing alone” and raises the question of whether they get favorable economics, volume commitments, or exclusivity.
What’s not yet disclosed / what to watch
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Financial terms: The announcement does not disclose economics of the deal — revenue/royalty share, minimum ordering commitments, exclusivity, cost of integration, or potential claw-backs. That’s typical but means assumptions are required. Joshua Thompson+1
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Roll-out timeline & scale: They say “make more widely available” but do not specify how many systems/sites or when go-live begins. Execution will matter.
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Volume & reimbursement risk: Even with Medicare coverage, diagnostics companies often face payer coverage nuances, test utilization hurdles, and adoption delays—especially for prognostic vs diagnostic tests.
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Lab capacity / operations: As tests scale, Renalytix must ensure its lab operations, turnaround times, quality reporting, logistics, and order flows via Tempus’s network are robust.
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Evidence and outcomes: Although the test is FDA-cleared, broader real-world evidence (outcomes, cost-effectiveness, impact on care) will support broader adoption and payer negotiations.
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Retention & exclusivity: Without disclosed exclusivity, Tempus might bring in competing tests; the strategic advantage would be higher if Renalytix has a protected lane.
Strategic implications for your context
Given your work in reimbursement/market-access for diagnostics (and early-detection), you might draw these points when advising (or discussing) companies like Renalytix or analogous firms:
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This partnership example emphasises how distribution partnerships matter in diagnostics (especially for scale) and how they complement regulatory/reimbursement wins.
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The data-asset angle (multi-modal data accumulation) is increasingly important for companies in the platform/AI diagnostics space, not just test commoditisation.
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Even with FDA + Medicare, adoption remains a hurdle; thus, early engagement on payor economics, lab workflow integration, and health-system value proposition remains critical.
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Partnerships like this may shift the value proposition from “we have a test” → “we deliver actionable insights + integrate into system workflows + deliver data value”, which you might advise clients to reflect in their SOW or strategy.
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As of 2025, Tom McLain (Vermillion, Exosome) is listed on Linked In as a president at Renalytix. On the Renalytix website it is Howard Doran. As of 2025 James McCullough is CEO. Leaders.
