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Renalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled diagnostics for kidney disease, announces the completion of a joint venture partnership agreement with AKESOgen, an industry-leading commercial laboratory facility and provider of clinical trial precision medicine services located in Atlanta, Georgia.

AKESOgen brings a state-of-the-art 14,000 square foot CLIA¹ certified and CAP² accredited laboratory facility that enables RenalytixAI to immediately scale operations to support additional business partnerships on a variable-cost basis without incurring additional fixed overhead. RENX AI Labs provides RenalytixAI with further operations outside of its recently configured New York City-based clinical laboratory operations in JLABS, a Johnson & Johnson Innovation center.

The joint venture, named RENX AI Labs, LLC, significantly expands the operational capacity available to RenalytixAI.  RENX AI Labs will provide services directly to health systems and pharmaceutical companies located in all regions of the United States. The joint venture enables RenalytixAI to support prospective revenue generating contract research, clinical diagnostic and clinical trial services that are part of the Company’s core business model with KidneyIntelX™ and other products under development.

RENX AI Labs will help support the programs of pharmaceutical companies by applying AI-enabled diagnostics, beginning with KidneyIntelX™, which is currently undergoing clinical validation, to improve patient characterisation and enrich targeting of patients for drug clinical trials for renal disease. Better identification and characterisation³ of enrolled patients has the potential to reduce trial cost and duration and increases the likelihood of reaching successful outcomes. RENX AI Labs also has the capability to develop companion diagnostics under stringent quality-control processes.

Notes:

¹ The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/

² The College of American Pathologists (CAP’s) Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous customized checklist requirements. https://www.cap.org/laboratory-improvement/accreditation

³ Characterisation refers to an individual patient’s disease status and underlying biology. Kidney disease biology and status may vary from patient to patient and could have a material impact on whether or not a patient qualifies for a particular drug enrollment criteria.

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About Kidney Disease

Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. In the United States alone, over 40 million people are classified as having chronic kidney disease, with nearly 50 percent of individuals with advanced (Stage IV) disease unaware of the severity of their reduced kidney function. As a result, many patients progress to kidney failure in an unplanned manner, ending up having dialysis in the emergency room without ever seeing a clinical specialist, such as a nephrologist. Every day 13 patients die in the United States while waiting for a kidney transplant.

About RenalytixAI

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