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FDA Clears Thermo Fisher Scientific QMS Plazomicin Immunoassay

NEW YORK (GenomeWeb) – Thermo Fisher Scientific said on Monday that it has received clearance from the US Food and Drug Administration for the de novo submission of its Thermo Scientific QMS Plazomicin Immunoassay.

The quantitative immunoassay measures the concentration of a novel antibiotic, Zemdri (plazomicin), using the automated clinical chemistry analyzer Beckman Coulter AU 680.

Plazomicin is a next-generation aminoglycoside antibiotic that is used to treat patients with complicated urinary tract infections.

The assay was developed in collaboration with Achaogen, a biopharmaceutical firm with expertise in the development of antibacterial drugs to treat multidrug resistant (MDR) gram-negative infection.

"The measurement of levels of plazomicin in blood will enable [therapeutic drug monitoring]-adjusted plazomicin dosing in recommended patient populations," said Janet Dorling, chief commercial officer at Achaogen, in a statement. "Monitoring plazomicin drug levels with accuracy and precision has been an important goal, and with the achievement of this regulatory milestone, we are excited about the commercialization of the QMS Plazomicin Immunoassay from Thermo Fisher."

The new QMS Plazomicin Immunoassay adds to others in the Thermo Fisher line of therapeutic drug monitoring immunoassays across a range of drug classes, including antibiotics, antiepileptics, antiarrhythmics, and immunosuppressants.