Renalytix Plc Regulatory News (RENX)

This announcement contained inside information

Renalytix AI plc

("RenalytixAI" or the "Company")

RenalytixAI Partners with Capital District Physicians' Health Plan, Inc. on KidneyIntelX™

Effective October 16, KidneyIntelX will be covered for reimbursement for qualified members

Renalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announces that Capital District Physicians' Health Plan, Inc. (CDPHP®), a physician led health insurance provider, has adopted coverage determination policies that will provide KidneyIntelX™ for qualified CDPHP members who have Type 2 diabetes and chronic kidney disease (diabetic kidney disease or "DKD"). In the United States, approximately 12 million people currently have diabetic kidney disease1. Qualified CDPHP members are eligible for KidneyIntelX™ testing and score reporting for the risk of rapid progression of kidney disease.

A coverage determination policy is a determination of whether and under what circumstances a payor will pay for an item or service. Insurance coverage is typically limited to items or services that are considered by the payor as 'reasonable and necessary' for the diagnosis or treatment of an illness or injury. KidneyIntelX™ is designed to improve risk stratification and clinical management of patients with DKD in an effort to improve patient outcomes and health care system economics. KidneyIntelX™ uses machine-learning algorithms to assess a combination of predictive blood-based biomarkers and features from a patient's electronic health record. The list price for KidneyIntelX™ is $970 per reportable result.

John D. Bennett, MD, President and CEO of CDPHP said: "At CDPHP, we have been on a mission to support our members with diabetes to the best of our ability, offering programming and services to meet their lifestyle choices and needs. Coverage of KidneyIntelX™ for qualified members is a proactive step toward identifying and treating fast-progressing kidney disease."

James McCullough, Chief Executive Officer of Renalytix AI plc said: "This CDPHP coverage determination is an important milestone for opening market access to the predictive value and data assessment capacity of KidneyIntelX in this critical medical indication. CDPHP is a progressive thinking physician led payor group that is offering advanced technology solutions to help patients experiencing rapid kidney function decline to slow or prevent the devastating effects of end-stage renal disease and dialysis."

One of the greatest drivers of health care cost today is patients whose kidney disease is not diagnosed in time and face kidney failure and unplanned transition to dialysis. Each year kidney disease kills more people than breast and prostate cancer2.

In a recent study published April 1 20193, DKD patients who scored high-risk by KidneyIntelX™ were 10 times more likely to experience kidney failure than those who scored low-risk.For patients experiencing rapid progression of kidney disease and therefore most likely to advance toward end-stage renal disease and dialysis, there are several clinical management strategies and proven therapeutic options to slow the rate of disease progression and/or halt its progress.

Notably in the same study, greater than 95% of patients with a low KidneyIntelX™ score did not experience any progression of their kidney disease over the next 5 years. As a result, even though these patients have known diabetic kidney disease, they are unlikely to progress with their disease further and can remain at a primary care physician level for monitoring.

The person responsible for arranging the release of this announcement on behalf of the Company is

James McCullough, CEO. 

For further information, please contact:

About Kidney Disease 

Kidney disease is now recognised as a public health epidemic affecting over 850 million people globally. The Centers for Disease Control estimates there that 15% of United States adults or 37 million people currently have kidney disease. It is reported that 9 out of 10 adults with chronic kidney disease 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 CKD4. 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 die in the United States while waiting for a kidney transplant.

About CDPHP®

Established in 1984, CDPHP is a physician-founded, member-focused and community-based not-for-profit health plan that offers high-quality affordable health insurance plans to members in 26 counties throughout New York. For more information visit www.cdphp.com. CDPHP is also on Facebook, Twitter, LinkedIn, and Instagram.  

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. The Company'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 renalytixai.com

Notes

1 https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease 

2 https://www.ncbi.nlm.nih.gov/pubmed/30738630

3 https://www.biorxiv.org/content/10.1101/587774v1

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