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RenalytixAI Expands Leadership Team with Focus on Reimbursement ahead of roll-out of artificial intelligence clinical in vitro diagnostic KidneyIntelX ™

RenalytixAI plc (AIM: RENX), a developer of artificial intelligence-enabled diagnostics for kidney disease, announces the expansion of its leadership team with the appointment of diagnostic industry leader Thomas McLain as President and Chief Commercial Officer, effective immediately. In this non-Board role, McLain will be responsible for leading the commercial programme for KidneyIntelX ™ with a focus on establishing national and international clinical adoption and reimbursement.

McLain most recently led business and commercial strategy for the Exosome Diagnostics’ ExosomeDx® Prostate (Intelliscore) (“EPI”) test, a liquid biopsy diagnostic for identifying men at increased risk for aggressive or high grade prostate cancer. While at Exosome Diagnostics, McLain secured a series of milestones for EPI within the first 18 months of national launch including a CPT code, Medicare pricing of $760 per test, private payer coverage determinations for more than 200 million lives in the US, inclusion in National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, and a recent grant of FDA Breakthrough Device Designation.

McLain has been recognised as a leading voice for progressive diagnostic reimbursement strategy including innovative collaborations and programmes with private insurance groups to stimulate utility, outcome and health economic data collection leading to accelerated clinical adoption and positive coverage determinations. 

McLain has served as President, Chief Executive Officer (CEO), General Manager, Board Chair and Board member of numerous successful pharmaceutical, biotechnology and diagnostic companies. McLain most recently served as the General Manager, President and CEO, and Chief Operating Officer for Exosome Diagnostics, Inc., a leading developer of liquid biopsy diagnostics for use in personalised medicine. While there, McLain led the transition from a research to a commercial company and was instrumental in its successful acquisition.

Prior to joining Exosome Diagnostics, McLain was President and CEO of Vermillion, a medical diagnostics company focused on women’s health. While there, he led a strategic transformation of the company increasing its market capitalisation fivefold to over $100 million. Prior to joining Vermillion, he was the CEO of start-up Claro Scientific, a diagnostics company with a novel optics-based platform technology. Previously he was Chairman, CEO and President of Nabi Biopharmaceuticals, where he led the evolution of a plasma supply based business into a fully integrated biopharmaceutical company. Over his career, McLain has raised over $300 million in new capital and structured successful commercial alliances, joint ventures and research collaborations. McLain earned his B.A. at the College of the Holy Cross, and his M.B.A. from the University of Rochester.                                  

James McCullough, Chief Executive Officer, RenalytixAI commented: “I am honoured to welcome Tom to the RenalytixAI leadership team. Tom’s deep understanding of diagnostic product commercialisation, healthcare markets and reimbursement will be a great asset to our company.”

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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.