Deployment of Renalytix's KidneyIntelX bioprognostic testing in 1,112 adult diabetic kidney disease patients at Mount Sinai Health System demonstrated utility in driving guideline appropriate use of therapies, including SGLT-2 inhibitors and RAAS inhibitor use, and timely consultation to specialists in high-risk patients. The Mount Sinai clinical utility data was presented as a late-breaking ePoster session on June 5th at the American Diabetes Association 82nd Scientific Sessions® in New Orleans. In the study, more than half of KidneyIntelX prognostic tests were ordered by primary care physicians, followed by endocrinologists.

Application of guideline-based care, including therapeutics and appropriate specialist consultation, increased in proportion to reported risk of rapid progressive decline in kidney function (e.g., low, intermediate, or high risk). The breakdown of risk in the real-world evidence (RWE) population was similar to what was observed in peer-reviewed, published KidneyIntelX clinical validation cohorts: High risk 13% vs. 17%; intermediate 40% vs.

37%; and low risk 46% vs 46%. In the 1,112 patients tested, KidneyIntelX re-stratified patient's risk from standard kidney function metrics (eGFR and UACR) and identified high risk adult patients with type 2 diabetes that were in stages 1, 2, and 3 of chronic kidney disease. Most importantly, the KidneyIntelX test helped physicians overcome the inertia seen with novel therapeutics proven to slow CKD progression and reduce associated patient cardiovascular event risk.

As compared to patients who scored low risk, there were increases in use of anti-hypertensives, a 6-fold increase in the initiation of guideline-recommended treatments (SGLT-2 inhibitors or GLP-1 receptor agonists), and a nearly 3-fold increase in referrals to nephrologists, endocrinologists or dietitians. In the high-risk patient category, 20% of patients were referred to a specialist. Additionally, there was an increase in appropriate use of SGLT-2 inhibitor prescriptions by increased level of risk score.

There are approximately 71,000 patients with type 2 diabetes and chronic kidney disease in the Mount Sinai Health System across New York City. Clinical utility study results are being prepared to be published in a peer reviewed publication in 2022. The Mount Sinai Health System is New York City's large academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region.

KidneyIntelX is available clinically as a laboratory developed test. It has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and has been submitted to the FDA for De Novo marketing authorization. KidneyIntelX includes technology that was initially developed by Mount Sinai faculty.

This technology has been licensed by Mount Sinai to Renalytix. Mount Sinai and a small number of Mount Sinai faculty inventors have a financial interest in Renalytix. Mount Sinai also has representation on the Renalytix Board of Directors.