
Renalytix Receives Patents on Foundational Biomarkers for the KidneyIntelX.dkd Test
Renalytix plc, a diagnostic laboratory focused on renal disease, has announced that the United States Patent and Trademark Office (USPTO) has recently issued a notice of allowance of claims related to the biomarkers sTNFR1 and sTNFR2, which are integral components of Renalytix’s KidneyIntelX.dkd test. These claims, initially filed under US Patent Application No. 16/671.256 by the Joslin Diabetes Center, are now exclusively licensed to Renalytix.
This development bolsters the foundation of intellectual property supporting Renalytix’s KidneyIntelX technology. 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). Additionally, the Centers for Medicare & Medicaid Services (CMS) recently published the pricing for Renalytix’s FDA-authorized kidneyintelX.dkd test on the nationwide Clinical Laboratory Fee Schedule, setting it at $950.
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. 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.