Distinct from companion diagnostics, "complementary diagnostics" are a category of tests that provide additional information about how a drug might be used, or whether someone should receive a class of drugs, rather than being required for the safe and effective use of a drug (www.amplion.com). In addition to companion diagnostics, the FDA focuses on complementary diagnostics as of its framework for regulating laboratory-developed tests (LDTs).
Thermo Fisher Scientific's new quantitative immunoassay measures the concentration of a novel therapeutic antibiotic, plazomicin, using the automated clinical chemistry analyzer, Beckman Coulter AU680. Plazomicin is a next-generation aminoglycoside being used to treat patients with complicated urinary tract infections (cUTI). This is the first TDM assay available for quantifying drug levels of plazomicin in human K2 EDTA plasma.
TDM assays enable 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. Ready-to-use and designed to provide precise measurement of antibiotic drug concentrations, the QMS TDM assay measures the concentration of plazomicin using the Beckman Coulter AU680 automated clinical chemistry analyzer. It employs proprietary technology across a range of drug classes including those for antibiotics, antiepileptics, antiarrhythmics, immunosuppressants, and others.
This FDA cleared assay correlates greater than 0.975 with LC-MS/MS and provides an average accuracy of 100% across the assay range. Other key features:
- High reproducibility for confidence in results with a total precision less than 7% CV
- Faster turnaround time
- Convenient liquid, ready-to-use format
The President of the Clinical Diagnostics Division of Thermo Fisher, Lonnie Shoff, said in a press release, "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."
This immunoassay was developed in collaboration with Achaogen, Inc., a biopharmaceutical company to address multi-drug resistant (MDR) gram-negative infection.