Three Antimicrobial Susceptibility Tests Approved for Baxdela
The Food and Drug Administration (FDA) has cleared 3 antimicrobial susceptibility tests (ASTs) that can help guide clinicians toward appropriate usage of Baxdela (delafloxacin; Melinta Therapeutics).
Baxdela, a fluoroquinolone antibiotic, was approved earlier this year for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. The newly cleared ASTs include: Hardy Diagnostics' Delafloxacin Antimicrobial Susceptibility Disk (HardyDisk), Liofilchem Delafloxacin MIC Test Strip (MTS), and Thermo Scientific Sensititre MIC System.
Susceptibility tests can determine how effective specific antibiotics work against bacterial pathogens and aid in a physician's understanding of the appropriate use of an antibiotic. “Melinta's team has been working with manufacturers for the last few years to develop these antimicrobial susceptibility tests in parallel with our Phase 3 PROCEED studies,” said Melinta's CMO Sue Cammarata, M.D.
HardyDisks, product number Z9301 (single pack) and Z9305 (pack with 5 cartridges), are available along with a large selection of susceptibility disks.
Liofilchem Delafloxacin MIC Test Strip 0.002-32μg/mL is a quantitative assay for determining the minimum inhibitory concentration of delafloxacin against Staphylococcus aureus (including methicillin-resistant and methicillin susceptible isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, and Enterococcus facecalis; the product is available in packs of 10, 30, and 100 strips.
The Thermo Scientific Sensititre System can be used to perform delafloxacin susceptibility testing manually, or using the Sensititre Vizion Digital MIC Viewing System, Sensititre OptiRead Automated Fluorometric Plate Reading System, or the fully automated Sensititre ARIS 2X System.
"Because these tools will be available with Baxdela at launch, doctors will have the full set of clinical tools they need in order to make a clinical decision on how to treat patients appropriately,” added John Temperato, Melinta's president and chief operating officer.
For more information visit Melinta.com.