Impact of 21st Century Cures Act on Breakpoints and Commercial Antimicrobial Susceptibility Test Systems: Progress and Pitfalls

Antimicrobial resistance is the most pressing medical challenge of the past decade. At the frontline are clinical laboratories, responsible for accurately reporting antimicrobial susceptibility test (AST) results to clinicians and public health authorities. The ability of the laboratory to detect resistance has been hampered by several factors. In 2016, the 21 st Century Cures Act was signed into law, marking an important step towards resolving many regulatory dilemmas that hampered development and updates to commercial AST systems (cASTs). We describe the pathway and history of U.S. regulation of cASTs and outline both the rewards unmet needs possible from 21 st Century Cures.