Renalytix plc

Renalytix develops and offers KidneyIntelX, a diagnostic platform that includes the kidneyintelX.dkd testing service. KidneyIntelX refers to the company's diagnostic platform and products developed from it, including a laboratory developed test offered across the United States from CLIA certified laboratories. The kidneyintelX.dkd specific testing service from this platform received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) on June 29, 2023. KidneyintelX.dkd is the first FDA-authorized in-vitro prognostic test. It combines blood biomarkers and an artificial intelligence-enabled algorithm to help assess the risk of progressive decline in kidney function in adults with type 2 diabetes and early-stage kidney disease. The test aims to identify patients most at risk for significant sustained decline in kidney function during the early stages of the disease. When used as intended, kidneyintelX.dkd can support decisions on medical interventions early in the disease process, potentially avoiding kidney failure that requires long-term dialysis or a kidney transplant. The current addressable market for kidneyintelX.dkd in the US is approximately 14 million patients with adult diabetes and diagnosed chronic kidney diseases. Globally, the addressable market is estimated to be 260 million patients. The kidneyintelX.dkd test received formal Medicare coverage in June 2024 at $950 per test and has also received coverage from several major insurance plans, including large state Blue Cross Blue Shield plans. The majority of US patients who meet the intended use for kidneyintelX.dkd are expected to be over 65 years old and covered by Medicare.