Renalytix Plc Regulatory News (RENX)

This announcement contains inside information

Renalytix AI plc

("RenalytixAI", the "Company")

KidneyIntelX™ receives New York State approval to commence commercial testing

NEW YORK, June 12, 2020 - Renalytix AI plc (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and lower healthcare costs, announces that it has received a clinical laboratory permit from the New York State Department of Health (NYS DOH) to provide commercial testing of KidneyIntelX™. The permit was granted following an extensive review by a panel of NYS DOH scientists and external reviewers of the analytical and clinical validation results for KidneyIntelX. Additionally, officials from the NYS DOH successfully completed an inspection of the RenalytixAI New York laboratory as part of this process, with no findings reported.

Highlights

· Approval to commence commercial testing issued by New York State Department of Health's Clinical Laboratory Evaluation Program

· RenalytixAI now moving to complete full KidneyIntelX commercial integration with Mount Sinai Health System with patient testing to begin in Q3 2020

· With licensed CLIA commercial laboratories in Utah and New York, RenalytixAI can now provide KidneyIntelX testing services in 47 states with expected licensure for California, Maryland and Pennsylvania in 2020

Effective immediately, KidneyIntelX may now be used to report risk assessment results for fast-progressing kidney disease and future kidney failure for patients with Type 2 diabetes and chronic kidney disease. With this approval, RenalytixAI will move to complete its full commercial launch of KidneyIntelX with Mount Sinai Health System and expects to begin reporting patient results in the third quarter of this calendar year.

KidneyIntelX is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment of progressive kidney function decline within a period up to five years. A progressive decline in kidney function occurs when one or more of the following conditions are observed:

· Rapid Kidney Function Decline (RKFD) in eGFR slope of ≥ 5 ml/min/1.73m2/year;

· a sustained decrease in eGFR ≥ 40% confirmed at least 3 months apart; or

· kidney failure, defined by sustained eGFR < 15 ml/min/1.73m2, initiation of long-term dialysis or kidney transplantation.

As announced on 10 June, a recent expanded multi-centre validation study demonstrated that KidneyIntelX can identify patients at the highest risk of progressive decline in kidney function in early stage diabetic kidney disease with higher accuracy than existing care methods.

The New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) regulates and oversees clinical diagnostic laboratories that test biological specimens from New York State residents. The CLEP seeks to ensure the accuracy and reliability of test results in clinical laboratories located within the state or that accept specimens from New York State residents.

While approval for KidneyIntelX patient testing has been granted for an indefinite period, it is subject to ongoing compliance with New York Department of Health regulations and standards. NYS DOH reserves the right to request more information and to withdraw the approval should evidence of non-compliance be identified.

For further information, please contact:

The person responsible for this announcement is James McCullough, CEO.

About Kidney Disease 

Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. The Centers for Disease Control and Prevention (CDC) estimates that 15% of US adults, or 37 million people, currently have chronic kidney disease (CKD). Further, the CDC reports that 9 out of 10 adults with CKD do not know they have it and 1 out of 2 people with very low kidney function who are not on dialysis do not know they have CKD*. Kidney disease is referred to as a "silent killer" because it often has no symptoms and can go undetected until a very advanced stage. Each year kidney disease kills more people than breast and prostate cancer. Every day, 13 patients in the United States die while waiting for a kidney transplant.

* https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html

About RenalytixAI

RenalytixAI is a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. RenalytixAI's products are being designed to make significant improvements in kidney disease diagnosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit www.renalytixai.com.