Waters UPLC I-Class/Xevo TQ-S System Approved for In Vitro Diagnostic Use in China
April 14 2015 - 8:35AM
Business Wire
Waters Corporation (NYSE: WAT) today announced that the Chinese
Food and Drug Administration (CFDA) approved the Waters® ACQUITY
UPLC® I- Class IVD/Xevo® TQ-S IVD System for in vitro diagnostic
(IVD) use in China. The system was approved for clinical analysis
of a variety of compounds that include diagnostic indicators and
compounds for treatment monitoring.
"The practice of medicine is changing from a reactive approach
to treating disease, to one that is more proactive and preventive,"
said Jeff Mazzeo, Senior Director, Health Sciences for Waters
Division. "To facilitate this transition, better diagnostic and
predictive tools are needed so that disease can be detected earlier
or even prevented. That is where Waters technologies like the
ACQUITY® TQD System and ACQUITY UPLC I-Class IVD/Xevo TQ-S IVD
systems, approved for IVD use by the CFDA in 2014 and 2015,
respectively, can make a significant impact."
Using LC-MS technology, clinical laboratories perform
qualitative and quantitative analyses of patients' samples to aid
clinicians in many ways. These tests may be used to confirm a
clinical suspicion (including making a diagnosis); assist in the
selection, optimization and monitoring of treatment; provide a
prognosis; screen for disease in the absence of clinical signs or
symptoms; and establish and monitor the severity of physiological
disturbance. Liquid chromatography separates analytes and
interferents within a given sample, while mass spectrometry
technology is used for detection and confirmation of those
analytes.
The recently CFDA approved ACQUITY UPLC I-Class IVD/Xevo TQ-S
IVD System features Waters' UltraPerformance LC® technology coupled
with a tandem quadrupole mass spectrometer designed for the most
demanding UPLC-MS/MS quantitative analysis. This system uses
StepWave™, a breakthrough off-axis ion source technology, and
RADAR™, an information rich acquisition method, enabling the system
with sensitivity and robustness.
For more information, please visit Waters' Clinical application
page.
About Waters Corporation
(www.waters.com)
For over 50 years, Waters Corporation (NYSE: WAT) has been
enabling significant progress in the fields of healthcare,
environmental management, food safety, and global water quality
monitoring by providing practical and sustainable innovations, thus
creating business advantages for laboratory-associated
organizations.
As a pioneer in separation science, laboratory information
management, mass spectrometry, and thermal analysis technology,
Waters has created a sustainable platform with its technical
breakthroughs and laboratory solutions for the success of its
clients.
Waters achieved revenues of $ 1.99 billion in 2014, and it will
continue to lead its clients to explore science and achieve
excellence.
Waters, ACQUITY, ACQUITY UPLC, UPLC, XEVO, StepWave and RADAR
are trademarks of Waters Corporation.
Waters CorporationJeff Tarmy,
508-482-2268jeff_tarmy@waters.com
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