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FDA Approves Three Tests for Determining Appropriate Use of Skin Infection Drug

NEW YORK (360Dx) – Melinta Therapeutics said this week that the US Food and Drug Administration has cleared three antimicrobial susceptibility tests to help guide physicians in the use of Melinta's drug to treatment for bacterial skin and skin structure infections.

The FDA-cleared tests — Hardy Diagnostics' Delafloxacin Antimicrobial Susceptibility Disk, Liofilchem Delafloxacin MIC Test Strip, and Thermo Fisher Scientific's Sensititre MIC System — were cleared for assessing patients who may be appropriate for Melinta's treatment called Baxdela. The fluoroquinolone was also approved by the FDA for treating adults with bacterial skin and skin structure infections caused by susceptible bacteria with demonstrated in vitro and clinical activity against Gram-positive and Gram-negative pathogens, including activity against methicillin-resistant Staphylococcus aureus.

Hardy Diagnostics' Delafloxacin Antimicrobial Susceptibility Disks are impregnated paper disks used for antimicrobial susceptibility testing. Liofilchem Delafloxacin MIC Test Strip is a quantitative assay for determining the minimum inhibitory concentration of delafloxacin against S. aureus, S. haemolyticus, S. lugdunensis, and Enterococcus facecalis, Melinta said.

Thermo Fisher's Sensititre MIC System provides minimum inhibitory concentration results and a large, up to date selection of antimicrobials, the drug firm added.

The tests will be available with Baxdela at launch, Melinta said. As a result, "doctors will have the full set of clinical tools they need in order to make a clinical decision on how to treat patients appropriately," Melina President and COO said in a statement.