KidneyIntelX® Delivers Unprecedented Two-Year Real-World Outcomes in Diabetic Kidney Disease: No Comparable Risk Assessment Tool Exists
Rhea-AI Summary
Renalytix (OTCQB:RNLXY) reported two-year real-world outcomes for its FDA-approved KidneyIntelX.dkd test in 2,470 patients with type 2 diabetes and early CKD across two major U.S. health systems.
According to Renalytix, risk-guided care was linked to improved kidney function, biomarker reductions, and greater use of guideline-directed therapies.
Positive
- Study followed 2,470 patients with type 2 diabetes and early CKD over two years
- About 29% of retested patients moved into a lower risk category with biomarker reductions
- High-risk patients were 10.4x more likely to experience kidney decline than low-risk, showing strong risk separation
- High-risk SGLT2 inhibitor use reached 56% overall and 70% at Mount Sinai
- Combination SGLT2 inhibitor and GLP-1 therapy in high-risk patients rose from 12% to 32%
- Rate of eGFR decline in high-risk patients improved by 43% over two years
- High-risk patient UACR decreased by 23% and HbA1c by 7.6% over two years
Negative
- None.
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Landmark study of 2,470 patients across two
Spanning 2,470 patients with type 2 diabetes and early-stage chronic kidney disease (CKD) across two major
"These two-year data provide the clearest real-world picture yet of what risk stratification can do when applied consistently at scale in two large health systems. What we see is that a structured, biomarker-guided approach to prescribing translates into targeted therapy decisions — higher-risk patients receiving more intensive treatment, and lower-risk patients largely spared unnecessary escalation. That is what precision medicine is supposed to look like in practice."
- Dr David Lam, Co-Principal Investigator
Endocrinologist with the Mount Sinai Health System
A LEAP BEYOND PRIOR EVIDENCE
The KidneyIntelX real-world evidence program has evolved from the 6- to 12- to 24-month time periods, demonstrating sustainable clinical improvements tied to how the test's risk stratification successfully informs guideline-directed medical treatment (GDMT).
- 6-Month RWE: Established that KidneyIntelX risk results changed clinician decision-making and GDMT in a real-world setting.
- 12-Month RWE: Confirmed that these changes in risk-stratified GDMT were associated with meaningful improvements in kidney, cardiac, and metabolic markers (eGFR slope, UACR, HbA1c, blood pressure).
- Just released 24-Month RWE data demonstrates: (1) that KidneyIntelX is a dynamic, longitudinal risk tool, not just a one-time test; (2) that blood-based biomarkers strongly influence changes in risk level; (3) robust independent prognostic performance in two contemporary care settings, and (4) GDMT (e.g., SGLT2 inhibitors and GLP1 receptor agonists) use is significantly increased post-baseline risk assessment.
KEY TWO-YEAR DATA HIGHLIGHTS
Prior studies showed the KidneyIntelX test influenced clinical decisions and improved immediate markers of kidney health. The two-year analysis proves these improvements translate into real and lasting benefits for patients.
29% of patients who were retested moved into a lower risk category, accompanied by biomarker reductions.- SGLT2 inhibitor use increased substantially across all risk groups over two years, reaching
56% in high-risk patients overall and soaring to70% in high-risk patients atMount Sinai . Combination SGLT2 inhibitor and GLP-1 receptor agonist therapy in high-risk patients nearly tripled, rising from12% to32% over the same period. - Patients who started SGLT2i or GLP-1 RA therapies had nearly double the odds (OR 1.93) of achieving risk reduction — demonstrating a real-world link between treatment informed by kidneyintelX.dkd results and patient benefit.
- KidneyIntelX demonstrated powerful independent prognostic performance: patients designated as high-risk at baseline were 10.4 times more likely to experience significant kidney function decline or kidney failure than low-risk patients, even after adjusting for standard clinical variables. No standard clinical combination — eGFR, UACR, HbA1c — has achieved risk separation of this magnitude.
- From baseline to two years, the rate of eGFR decline improved by
43% , UACR decreased by23% , and HbA1c decreased by7.6% in high risk patients, while systolic blood pressure remained stable across all risk groups.
"From a nephrology standpoint, what matters most is whether risk stratification translates into durable kidney protection — and that is what we are seeing here. The attenuation in eGFR decline rate sustained over two years, alongside reductions in UACR, reflects real change. The repeat testing data demonstrate nearly a third of high-risk patients moved to a lower risk category at one year, linked to measurable drops in KIM-1 and to initiation of therapy. This longitudinal signal helps nephrologists make care decisions and assess response to therapy."
- Dr Joji Tokita, Co-Principal Investigator
Nephrologist with the Mount Sinai Health System
About Renalytix plc
Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in vitro diagnostics company dedicated to optimizing kidney disease management through precision based care intervention. It's KidneyIntelX™ technology and data-driven insights help clinical teams understand patient level of risk for progressive decline in kidney function in the earliest stages of diabetic kidney disease. This enables clinicians to focus resources and guideline-recommended treatment, providing the best chance for improving kidney and overall renal-cardio-metabolic outcomes. Renalytix has received FDA approval and Medicare reimbursement for kidneyintelX.dkd which is offered commercially throughout the United States. To learn more about Renalytix, visit renalytix.com, and for information about the kidneyintelX.dkd test, visit kidneyintelx.com.
For further information, please contact:
Renalytix plc
Elise Wilfinger
Chief Strategy & Marketing Officer
ewilfinger@renalytix.com
www.renalytix.com
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SOURCE Renalytix