Thermo Fisher gets FDA nod for plazomicin immunoassay
- Thermo Fisher Scientific said it received FDA De Novo clearance for a first-of-a-kind complementary diagnostic immunoassay to measure concentrations of plazomicin, a therapeutic antibiotic.
- The antibiotic plazomicin, marketed as Zemdri, is an aminoglycoside used to treat patients with complicated urinary tract infections.
- The therapeutic drug monitoring (TDM) immunoassay was developed in collaboration with the biopharmaceutical company Achaogen and uses the Beckman Coulter AU 680 automated clinical chemistry analyzer to measure plazomicin.
Fremont, California-based Thermo Fisher's TDM assays allow physicians to administer and monitor drugs on an individual patient basis. The assays are intended to help maintain optimal drug levels, and minimizing the potential for under or over dosage.
The immunoassays use proprietary technology across a number of drug classes, including antibiotics, antiepileptics, antiarrhythmics and immunosuppressants.
Achaogen, based in South San Francisco, California, specializes in antibacterial drug development to address multi-drug resistant infection.
According to Achaogen, the drug plazomicin, or Zemdri, is intended for use in a subset of more than one million annual cases of multi-drug resistant or recurrent complicated urinary tract infections in the United States.
The QMS Plazomicin Immunoassay measures plazomicin in human plasma using automated clinical chemistry analyzers. Zemdri is approved to treat complicated urinary tract infections, including pyelonephritis, due to enterobacteriaceae.
"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," Janet Dorling, chief commercial officer at Achaogen, said in a press release.