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Waters CE Marks In Vitro Diagnostic MassTrak Immunosuppressants XE Kit
Date:7/25/2011

ATLANTA, July 25, 2011 /PRNewswire/ -- Waters Corporation (NYSE: WAT) today announced that its MassTrak™ Immunosuppressants XE Kit is now CE-marked in accordance with the IVD Directive 98/79/EC, for the quantitative measurement of the immunosuppressive drugs tacrolimus (FK506;Prograf®) in liver and kidney transplant patients and everolimus (Certican®) in adult kidney and cardiac transplant patients from human whole blood samples as an aid in the management of immunosuppressant drug therapy.

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Waters LC/MS/MS system, consisting of the MassTrak™ Immunosuppressants XE Kit and method, the Waters ACQUITY UPLC® UltraPerformance Liquid Chromatography system coupled to an ACQUITY® TQD tandem quadrupole mass spectrometer, offers enhanced sensitivity and specificity, and measures target compounds at low ng/mL levels (0.5 ng/mL).

"LC/MS plays an increasingly important role in many clinical laboratories today. Waters is committed to advancing technology-based diagnostic solutions in the clinical laboratory that impact the quality of results in many  areas including immunosuppressant drug monitoring," said Mark Bruns, Senior Director, Clinical Business Operations, Waters Division.

With the instrumentation and kit, clinical laboratories in the European Economic Area and Switzerland will no longer have to spend time and money to develop and validate in house LC/MS/MS methods for tacrolimus or everolimus, or source calibrators, QCs, and internal standards. Waters clinical specialists will support the system and methodology.  

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