The launch of this system is an attempt to make headway in an increasingly crowded and competitive analytical technologies market. The liquid chromatography, mass spectrometry and thermal analysis market account for $4.5 - $5.0 billion (€3.5 - €3.9 billion) of the overall $20+ billion (€15.6 billion) analytical instrument market.
At the centre of Waters MassTrak Clinical Solutions is Waters LC/MS/MS technology, which includes the Quattro series of tandem mass spectrometers, and the Alliance series of HPLCs with software optimised for clinical research applications and methodology.
The MassTrak Clinical Solutions approach enables researchers to measure trace levels of analytes with high specificity and sensitivity in a robust, high throughput system with simple sample preparation.
The ability to accurately measure drug levels in whole blood is vital for effective quantification of immunosuppressant drugs. The traditional method for monitoring these drugs is by drug-specific immunoassays. The poor specificity of immunoassays is often a problem since cross-reactivity from drug metabolites can lead to erroneously high concentration estimates for the target compound. Depending on the analyte of interest, immunoassay reagents can also be expensive.
The specificity provided by LC/MS/MS, which uses molecular mass to distinguish parent drug molecules from metabolites, overcomes the problems of immunoassays and delivers accurate and precise results in minutes. With MassTrak Systems, Therapeutic Drug Monitoring is automated, and takes only a few minutes per sample. Sample pre-treatment is extremely simple and operating costs are low when compared to immunoassays.
"The analysis of drugs in complex matrices requires the highest levels of speed, accuracy and sensitivity in a robust, easy-to-use system," said Mike Yelle, senior director of clinical business operations at Waters.
"MassTrak Systems have been designed to bring the enabling benefits of LC/MS/MS technology to clinical research. We are committed to ensuring our customers' success with complete solutions to improve the accuracy and precision of their assays," he added.