FDA approves Thermo Fisher’s QMS Plazomicin Immunoassay

Thermo Fisher Scientific has received FDA approval for the Thermo Scientific QMS Plazomicin Immunoassay, developed in collaboration with Achaogen, Inc. It is a complementary diagnostic immunoassay that measures the concentration of a novel therapeutic antibiotic, plazomicin, using the automated clinical chemistry analyzer, Beckman Coulter AU 680. Plazomicin is a next-generation aminoglycoside being used to treat patients with complicated urinary tract infections.
Achaogen’s CCO, Janet Dorling, said: “Therapeutic drug monitoring aims to improve patient outcomes and reduce costs. The measurement of levels of plazomicin in blood will enable TDM-adjusted plazomicin dosing in recommended patient populations. 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.”
Lonnie Shoff, president clinical diagnostics at Thermo Fisher, said: “The commercialization of our FDA cleared QMS Plazomicin immunoassay is representative of our continued commitment to meet the needs of our biopharmaceutical development partners and the patients whom they serve. QMS TDM immunoassays are liquid, ready-to-use and designed to provide precise and accurate measurement of drug levels in patients.”