CLN Article

Three Antimicrobial Susceptibility Tests Get FDA Nod

Regulatory Roundup: December 2017

The Food and Drug Administration (FDA) has granted 510(k) clearance to three antimicrobial susceptibility tests (ASTs) that are designed to guide appropriate use of the antibiotic Baxdela (delafloxacin). Developed by Melinta Therapeutics, Baxdela is an FDA-approved fluoroquinolone indicated in adults for the treatment of acute bacterial skin and skin structure infections caused by gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus. The three ASTs cleared for use with this antibiotic are: Hardy Diagnostics’ Delafloxacin Antimicrobial Susceptibility Disk (HardyDisk), Liofilchem Delafloxacin MIC Test Strip, and Thermo Scientific Sensititre MIC system.

The HardyDisk is available along with a large selection of susceptibility disks that include the most recent approved antibiotics. The Liofilchem test is a quantitative assay that determines the minimum inhibitory concentration (MIC) of delafloxacin against Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus lugdunensis, and Enterococcus faecalis. The Thermo Scientific Sensititre system provides MIC results and a broad, up-to-date selection of antimicrobials, including a complete range of standard MIC plates and the ability to create custom plates tailored to a lab’s formulary.