Renalytix Appoints Joseph Hutson Vice President of Global Quality and Regulatory

Hutson to Build on Renalytix Quality and Regulatory Strategy for KidneyIntelX Global Commercialization

NEW YORK and SALT LAKE CITY, July 22, 2021 (GLOBE NEWSWIRE) -- Renalytix Plc (NASDAQ: RNLX) (LSE: RENX) today announced the appointment of Joseph Hutson as its Vice President of Quality and Regulatory. Hutson brings 23 years of experience in the life sciences industry, including quality and regulatory leadership roles at Cardinal Health, CareFusion, Becton Dickinson and Abbott Diagnostics. He will lead teams focused on assuring compliance with United States and international Quality Management System regulations and standards and driving efficient approval for a series of products under the KidneyIntelX brand through review by the appropriate regulatory authorities including the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and other country specific regulatory bodies.

The KidneyIntelX commercial program is being designed to CLIA, CAP, ISO, FDA, and In Vitro Diagnostics Regulation (IVDR) regulations and international standards which will support global market access for current and future KidneyIntelX innovative products and services. KidneyIntelX is currently under FDA review for De Novo marketing authorization under Breakthrough Device designation. Hutson will contribute his knowledge and expertise to the efficient FDA review of this submission.

“The dynamic quality and regulatory environments in the United States, Europe and across the world are now a critical part of building competitive differentiation and gaining access to global markets. Without a robust Quality Management System and well-defined regulatory strategies for product development, approval, and marketing, it is impossible to remain product competitive,” said Hutson. “Particularly in an area as large and consequential to global health-care systems as kidney disease, implementing processes that can meet or exceed FDA regulations and IVDR’s standards of quality and safety will be the requirement to set a new level of care for early-stage prognosis and treatment.”

Most recently, at Abbott Molecular Diagnostics, Hutson led Quality, Global and Clinical Compliance and he played an integral role in the rapid development, FDA Emergency Use Authorizations, manufacturing scale up and global distribution of 50 million COVID-19 diagnostic tests throughout the world. Previously, he served as Worldwide Vice-President, Quality and Regulatory at Becton Dickinson Respiratory Solutions with responsibility for 31 locations in North and South America, Europe, and Asia and as Global Vice-President, Quality and Regulatory at CareFusion acquired by Becton Dickinson in 2015.