
Renalytix kidneyintelX.dkd Test Priced at $950 by Medicare
Renalytix plc, who markets a FDA-approved artificial intelligence (AI)-enabled prognostic blood tests for individuals with type 2 diabetes and chronic kidney disease, has achieved a significant milestone. The Centers for Medicare & Medicaid Services (CMS) has officially published the pricing for Renalytix’s FDA-authorized kidneyintelX.dkd test on the nationwide Clinical Laboratory Fee Schedule, setting it at $950.
Earlier in the year, an expert panel convened by the American Medical Association (AMA) recommended that the FDA-authorized kidneyintelX.dkd test be assigned a distinct code to differentiate it from the original Laboratory Developed Test (KidneyIntelX). This recommendation by the AMA triggered a comprehensive national pricing review by CMS (Medicare), which has now concluded with the publication of the test’s price on the national Clinical Laboratory Fee Schedule at $950.
This pricing, once finalized in the fourth quarter of 2023, will become effective from January 1, 2024, and will be maintained for a minimum of three years. Renalytix views this action by CMS, which involved both expert and public review and comment, as a validation of the KidneyIntelX testing platform’s value. Importantly, it also simplifies the process of maintaining and expanding health insurance coverage in the United States.
KidneyIntelX is a laboratory-developed test (LDT) designed to provide valuable insights into kidney health for adults with type 2 diabetes and chronic kidney disease in stages 1-3. The test employs a proprietary bioprognosis™ methodology, offering risk assessment for rapid progressive decline in kidney function during these early stages, where intervention can have the most significant impact on patient outcomes. The test utilizes specific biomarkers (biological factors) that have been clinically proven through multiple studies to be highly prognostic for kidney disease. These biomarkers include TNFR1, TNFR2, and KIM-1. Additionally, KidneyIntelX considers seven key data points from a patient’s health record. These data points include eGFR, UACR, serum calcium, HbA1c, systolic blood pressure, platelet count, and AST levels. These factors provide crucial insights into kidney and other organ health or dysfunction. An advanced machine learning algorithm processes this diverse set of proprietary data inputs. It then generates a patient-specific risk score, which is easy for both patients and healthcare providers to understand.
The unique aspect of KidneyIntelX is its ability to predict which patients are at low, intermediate, or high risk for rapid progressive decline in kidney function. This prediction can help guide healthcare decisions and interventions. Approximately 50% of patients receive a low-risk score. This means they have the lowest risk for progressive kidney function decline, with a less than 10% chance of such decline over the next five years. About 35% of patients fall into this category. An intermediate risk score suggests the need for more frequent kidney health monitoring, possibly including additional visits, blood work, lifestyle changes, and specialized medications. Roughly 15% of patients receive a high-risk score, indicating a 60% or higher chance of progressive kidney function decline over the next five years. With a high-risk score, more aggressive treatment approaches may be necessary, such as frequent follow-up visits, nephrologist referrals, and medication adjustments. KidneyIntelX has received FDA Breakthrough Device Designation and the FDA granted marketing authorization to Renalytix for its KidneyIntelX.dkd™ prognostic test in June, making it a first-in-class, AI-enabled prognostic testing platform for adults with type 2 diabetes and early-stage chronic kidney disease (diabetic).
In an analysis of KidneyIntelX within the CANagliflozin cardioVascular Assessment Study (CANVAS), the study demonstrated KidneyIntelX’s ability to stratify the risk of adult patients with kidney disease for significant health outcomes. The results revealed that individuals with high-risk KidneyIntelX scores were three times more likely to experience hospitalization for heart failure, severe kidney disease progression, or death. Additionally, high-risk patients benefited the most from treatment with canagliflozin compared to a placebo.