Bringing Antimicrobial Susceptibility Testing for New Drugs into the Clinical Laboratory: Removing Obstacles in Our Fight against Multidrug-Resistant Pathogens

Abstract

There are now several new antibiotics available to treat multidrug-resistant pathogens, and susceptibility testing methods for these drugs are increasingly available at the time of drug approval. However, lack of clarity regarding verification requirements remains a formidable barrier to introducing such testing in clinical laboratories, making these drugs practically unavailable for patient use. We propose a change in the framework for bringing in testing for new antibiotics, focusing on quality control rather than underpowered verification studies.

Keywords: antibiotic resistance; antimicrobial susceptibility testing; new antibiotic; quality control; validation; verification.