FDA Clears Thermo Fisher Scientific's QMS Plazomicin Immunoassay

Thermo Fisher ScientificThe FDA has cleared the Thermo Scientific QMS Plazomicin Immunoassay, the first of its kind for complementary diagnostic immunoassays. Jointly developed by Thermo Fisher Scientific and Achaogen, this quantitative immunoassay measures the concentration of a novel therapeutic antibiotic, plazomicin, using the Beckman Coulter AU680 automated clinical chemistry analyzer.
This Plazomicin immunoassay, which is the latest addition to Thermo Fisher's line of therapeutic drug monitoring (TDM) immunoassays, enables physicians to monitor and administer therapeutics on an individual patient basis. By maintaining optimized drug levels, the effects of under or over dosage may be minimized and patient outcome improved. The company's immunoassays employ proprietary technology across a range of drug classes including those for antibiotics, antiepileptics, antiarrhythmics, immunosuppressants, and others.

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."

"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," said Janet Dorling, Chief Commercial Officer at Achaogen.

A world leader in science, Thermo Scientific® offers a wide range of products for clinical and research laboratories. These include the IEC Clinical centrifuge, Indiko®Plus Clinical and Specialty Chemistry System, and accessories and consumables for these products.

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