Renalytix Plc Regulatory News (RENX)

Renalytix AI plc

("RenalytixAI", the "Company")

Noridian Healthcare Solutions qualifies RenalytixAI as provider for services

Qualification an important milestone towards Medicare Coverage determination

Renalytix AI plc (LSE: RENX), the AIM-traded developer of clinical grade artificial intelligence in vitro diagnostics for kidney disease, announces that it has been granted a Medicare provider number for the Company's Salt Lake City Utah clinical laboratory.

The Company's application for a Medicare Provider Transaction Access Number ("PTAN") was reviewed by Noridian Healthcare Solutions, the regional Medicare Administrative Contractor ("MAC") with responsibility for overseeing facilities and providers located in the western United States. RenalytixAI is now qualified as a provider and can bill for services provided to patients with Medicare and Medicaid health insurance coverage in the United States.

The Company estimates that Medicare and Medicaid insurance programmes cover between 50% - 60% of patients likely to benefit from KidneyIntelX™ testing.

Receiving a Medicare PTAN is an important milestone toward obtaining a Medicare coverage determination for KidneyIntelX™. The Company is immediately initiating efforts to secure a Local Coverage Determination through the Molecular Diagnostic Services (MolDX) Program. MolDX was developed by Palmetto GBA, another MAC, in 2011 to identify and establish coverage and reimbursement for molecular diagnostic tests. This programme performs the following functions for MACs by:

· Facilitating detailed and unique identification through registration of molecular diagnostic tests to facilitate claims processing and to track utilization;

· Establishing clinical utility expectations;

· Completing technical assessments of published test data to determine clinical utility and coverage; and

· Establishing reimbursement.

When issued the local coverage determination will mean that the Salt Lake City laboratory can be reimbursed for KidneyIntelX™ testing for any Medicare and Medicare Advantage plan participant residing in the United States and its territories. This coverage determination would also apply to any other RenalytixAI laboratory in the region covered under an agreement with the MolDX program.

Further updates will be provided when appropriate.

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 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 clinical grade, artificial intelligence-enabled 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, and patient stratification for drug clinical trials. For more information, visit renalytixai.com