Press Releases

Renalytix Announces Two Data Presentations on KidneyIntelX™ at American Diabetes Association 82nd Scientific Sessions®

Real-world clinical utility in 1,112 patients tested with KidneyIntelX.
KidneyIntelX stratification for cardiovascular risk in 1,278 diabetic kidney disease patients

Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced its participation at the American Diabetes Association (ADA) 82nd Scientific Sessions® meeting in New Orleans from June 3-7, 2022. There will be two data presentations focused on the value of KidneyIntelX™ in care for adult patients with type 2 diabetes (T2D) and early-stage chronic kidney disease (CKD), including a late-breaking ePoster and an oral presentation.

The ePoster, “Clinical Utility of KidneyIntelX on Patients with Early-Stage Diabetic Kidney Disease—A Real-World Evidence Study” will be the first time Mount Sinai Health System is presenting data from its real-world evidence clinical utility study with Renalytix in 1,112 patients tested with KidneyIntelX. The poster will be presented to in-person and virtual conference attendees on June 5, at 12:00 p.m. CT, with commentary on behalf of the study investigators by Joji Tokita, M.D., Clinical Director, Division of Nephrology and Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai. Michael J. Donovan, Ph.D., M.D., Chief Medical Officer of Renalytix, will be available on-site for commentary.

A second oral presentation, “KidneyIntelX Association with Clinical Outcomes in Diabetic Kidney Disease” will be on June 3, at 4:45 p.m. CT by Steven G. Coca, D.O., M.S., Icahn School of Medicine at Mount Sinai, and Co-Founder of Renalytix.

“We’ve seen the ADA’s dedication to improving kidney health in people with T2D firsthand as part of our ongoing collaboration to develop a care pathway to advance screening, diagnosis and early-stage treatment for the 40% of these patients who will develop CKD,” said Tom McLain, President, Renalytix. “Chronic kidney disease can lead to significant complications for diabetes patients including cardiovascular disease and heart failure, and when left untreated can lead to dialysis and kidney transplant. Our mission is to give healthcare professionals new tools to understand an individual’s risk for rapid progression of CKD, allowing them to appropriately prescribe therapeutics and to utilize specialist consultation when necessary. We look forward to joining other industry leaders at this year’s Scientific Sessions in showcasing our research efforts.”

Renalytix will be exhibiting at booth #1803. The ePoster (Board No. 14) and oral presentation (Board No. 19) abstracts are available to conference attendees and public online through the 2022 ADA Scientific Sessions Online Planner.

KidneyIntelX is based on technology developed by Mount Sinai faculty and licensed to Renalytix. Mount Sinai and Mount Sinai faculty, including Dr. Coca, have a financial interest in Renalytix. Mount Sinai also has representation on the Renalytix Board of Directors.

About Kidney Disease
Kidney disease is a public health epidemic affecting over 850 million people globally.1 The Centers for Disease Control and Prevention estimates that 15% of U.S. adults, or over 37 million people,2 have chronic kidney disease (CKD). Nearly 95% of people with CKD are in early stages 1-3.3 Despite its magnitude, early-stage (1-3) CKD is underdiagnosed and undertreated, largely because it’s asymptomatic at this time in the disease. As many as 9 in 10 adults with CKD, and 2 in 5 adults with severe CKD do not know they have the condition.2

About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX) is an in-vitro diagnostics and laboratory services company that is the global founder and leader in the new field of bioprognosisTM for kidney health. The leadership team, with a combined 200+ years of healthcare and in-vitro diagnostic experience, has designed its KidneyIntelX laboratory-developed test to enable risk assessment for rapid progressive decline in kidney function in adult patients with T2D with early CKD stages 1-3 . We believe that by understanding how disease will progress, patients and providers can take action early to improve outcomes and reduce overall health system costs. For more information, visit www.renalytix.com.

About KidneyIntelXTM
KidneyIntelXTM is a laboratory-developed test demonstrated to be a reliable, bioprognosticTM methodology that yields a simple-to-understand, custom risk score, enabling prediction of which adult patients with T2D and early CKD (stages 1-3) are at low, intermediate or high risk for rapid progressive decline in kidney function. By combining information from KidneyIntelX with newer cardio- and reno-protective therapies, doctors will have more information in determining which patients are at higher versus lower risk for rapid disease progression and may be able to more appropriately target resources and guideline-recommended treatments to advance kidney health. KidneyIntelX is supported by a growing body of clinical, utility and health economic studies (including a validation study of two large cohorts) and has a demonstrated a 72% improvement in predicting those patients who are at high risk for rapid progressive decline in kidney function versus the current standard of care (eGFR and UACR). KidneyIntelX has also received Breakthrough Device Designation from the U.S. Food and Drug Administration and has submitted for De Novo marketing authorization. To learn more about KidneyIntelX and review the evidence, visit www.kidneyintelx.com.

Sources

1 https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/
2 https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html
3 https://www.cdc.gov/kidneydisease/basics.html