New published data for KidneyIntelX™

Electronic health record deployment of KidneyIntelX was associated with clinical actions that slowed progression of chronic kidney disease and improved Type 2 diabetes control in just 12 months

Results demonstrated a 61% increase in preventative drug prescriptions among patients in the high-risk group and improved specialist referrals which can significantly reduce overall cost of care and improve patient outcomes

LONDON and SALT LAKE CITY, January 10, 2024 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces publication of Real World Evidence ("RWE") after 12 months of follow-up in 2,569 patients with Type 2 diabetes and diabetic kidney disease ("DKD") at a major U.S. health system in Primary Care and Community Health. Results in the diverse cohort, including 27% black patients, demonstrate that electronic health record deployment of KidneyIntelX in vitro prognostic testing was associated with clinical actions that led to a significant slowing of chronic kidney disease progression and improved Type 2 diabetes control most notably in the highest risk patients.

Improved kidney health was evidenced by reduction in the rate of kidney function decline (eGFR slope) and diabetes control was evidenced by improved A1C levels. KidneyIntelX testing achieved scale through electronic health record integration, deploying directly to large treating groups of primary care physicians. These improvements, coupled with increase in percentage of KidneyIntelX high-risk patients achieving blood pressure control, have been shown to be associated with improvements in cardiovascular health and outcomes in CKD.

KidneyIntelX has received broad insurance payment coverage including through Medicare, Medicaid, and Blue Cross Blue Shield programs. The Food and Drug Administration (FDA) issued a de Novo Marketing Authorization of the kidneyIntelX.dkd version of the test in June 2023 with an indicated use addressable market of approximately 14 million patients with adult diabetes and kidney disease.

"The demonstrated benefits of KidneyIntelX early risk assessment at one year are significant and go to the core of chronic disease preventative medicine. This real-world data highlights the critical importance of early preventative care and the ability to better control cost and outcomes through efficient electronic deployment of KidneyIntelX bioprognosis," said Michael J. Donovan, PhD, MD, Chief Medical Officer at Renalytix. "We look forward to continuing published data releases in coming months in order to support our belief that KidneyIntelX provides actionable information leading to preventative care and improving healthcare outcomes."

"This published real world evidence puts KidneyIntelX at the intersection of multiple established diabetes, kidney and cardiovascular care guidelines. This data is compelling and shows the importance of adopting KidneyIntelX across primary care networks to help control these unsustainable chronic diseases that unnecessarily effect millions of patients," said James McCullough CEO of Renalytix.

The study population includes representation of a number of high-risk factors for disease progression including (a) patient median baseline age of 68 years (b) 27% Black, (c) median BMI of 30 (d) evidence of hypertension in 89% of subjects and (e) 9% with stage A-D, American Heart Association functional classified heart failure. Analysis of treating physicians shows that the majority of patients were being treated by their primary care physician.

The RWE study results demonstrated that patients with Type 2 Diabetes and Stage 1-3 CKD and a high-risk KidneyIntelX score received higher frequency of clinical management visits, improved utilization of guideline-recommended medications, and appropriate specialist referral or consultation for disease management compared to those who were identified as low or intermediate risk patients.

About Type 2 Diabetes

Sources

2 https://www.cdc.gov/diabetes/basics/type2.html

3 https://www.cdc.gov/diabetes/data/statistics-report/index.html

4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/