Business
KidneyIntelX™ included in KDIGO 2024 Guideline
KidneyIntelX™ included in KDIGO 2024 Guideline.
About this update from Renalytix Plc
[{"type":"text","content":"\n\n \n \nTHIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED IN ARTICLE 7 OF MAR. THE PERSON RESPONSIBLE FOR ARRANGING THE RELEASE OF THIS ANNOUNCEMENT ON BEHALF OF RENALYTIX IS JAMES MCCULLOUGH, CEO.\n \nRenalytix plc\n(\"Renalytix\" or the \"Company\")\n \nKidneyIntelX™ included in Final KDIGO 2024 Clinical Guideline for Chronic Kidney Disease (CKD)\n \nGuidelines highlight the importance of risk prediction and personalized treatment to reduce risk\n \nLONDON and SALT LAKE CITY, March 14, 2024 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX) (Renalytix) announces that the KidneyIntelX In-Vitro Diagnostic test has been included in the final KDIGO (Kidney Disease Improving Global Outcomes) 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD), published on March 13, 2024. In the release of the new guideline, timed to coincide with World Kidney Day on March 14, the KDIGO committee highlighted the role of risk prediction in guiding care for patients. In this context, KidneyIntelX is recommended for use as an externally validated tool for predicting disease progression in people with CKD stages G1-G3.\n \nThe Guideline Work Group recognized that the progression of CKD can occur at all stages, and that in earlier stages of disease (G1-G3), understanding the risk of 40% decline in kidney function over a short term 5 years, as per the indicated use of KidneyIntelX, is important for guiding early intervention, particularly in people at intermediate or high risk for progression. Renalytix received FDA de-novo marketing authorization for kidneyintelX.dkd in June 2023 for use in assessment of the risk of progressive decline in kidney function in patients with CKD stages G1-G3 and Type 2 Diabetes.\n \nSubsequent to the release of the draft content of this updated guideline in July 2023, further evidence has been published from clinical utility and outcomes studies with a current enrollment of more than 9,000 patients with Type 2 Diabetes and CKD G1-G3. In January 2024, published outcomes data from an analysis of more than 2,500 patients with one year of follow-up demonstrated that providing clinicians access to KidneyIntelX risk assessment to inform care was associated with clinical actions that resulted in sustained reduction...