Renalytix

Renalytix is an AI-enabled in vitro diagnostics company specializing in chronic kidney disease (CKD) management, particularly diabetic kidney disease (DKD). The company's flagship product, KidneyIntelX.dkd, combines proprietary AI algorithms with blood-based biomarker analysis, genetic data, and electronic health record integration to generate patient risk stratification scores for progressive kidney function decline. The test received FDA marketing authorization in Q2 2023 and Medicare coverage determination in June 2024. KidneyIntelX enables early identification of high-risk patients with type 2 diabetes and CKD stages 1-3b, allowing clinicians to optimize treatment targeting and resource allocation to slow or prevent disease progression. Renalytix operates CLIA-certified clinical laboratories and partners with major healthcare systems including Mount Sinai Health System, University of Michigan, and Singing River Health System. The company also provides biomarker discovery and drug development support services to pharmaceutical partners. With a focus on shifting kidney disease management from reactive treatment to proactive health optimization, Renalytix addresses a significant public health need affecting over 850 million people globally.