Company Expands Leadership Team with Focus on Reimbursement for Artificial Intelligence Clinical in Vitro Diagnostic, KidneyinteIX
Renalytix AI plc, 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 program 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 recognized as a leading voice for progressive diagnostic reimbursement strategy. His work includes innovative collaborations and programs 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 personalized 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 capitalization fivefold to over $100 million. Before joining Vermillion, he was the CEO of start-up, Claro Scientific, a diagnostics company with a novel optics-based platform technology. McClain also previously served as 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.
“I am honored to welcome Tom to the RenalytixAI leadership team,” said James McCullough, Chief Executive Officer, RenalytixAI. “Tom’s deep understanding of diagnostic product commercialization, healthcare markets and reimbursement will be a great asset to our company.”