2014

Waters Introduces Groundbreaking MassTrak Immunosuppressant Kit at AACC New Therapeutic Drug Monitoring Kit Is First to Receive Clearance from the

FDA for Use with LC/MS/MS



    MILFORD, Mass., July 13 /PRNewswire-FirstCall/ -- At the 2007 AACC
 Annual Meeting and Clinical Lab Expo, July 15 - 19, in San Diego, Waters
 Corporation (NYSE:   WAT, AACC Booth 2222) is introducing its MassTrak(TM)
 Immunosuppressant Kit for the monitoring of tacrolimus levels in kidney and
 liver transplant patients. Along with Waters liquid chromatography/mass
 spectrometry systems and Waters clinical service and support, the kit
 comprises a complete validated solution for transplant centers wishing to
 perform tacrolimus therapeutic drug monitoring. The kit, which recently
 received clearance from the U.S. Food and Drug Administration (FDA), is the
 first commercially available kit specifically designed to quantify the
 immunosuppressant tacrolimus in kidney and liver transplant patients by
 LC/MS/MS.
     The MassTrak kit combines quality controls, calibrators, an internal
 standard and HPLC column together with methodology that assures rapid,
 reliable, consistent and reproducible tacrolimus measurements. The kit
 introduction is a continuing demonstration of Waters commitment to solve a
 variety of challenges in the clinical laboratory.
     "At Waters, we understand and recognize that for customers to realize
 the benefits of LC/MS/MS based assays, we needed to provide validated
 robust methodologies with FDA cleared kits," said Michael Yelle, Senior
 Director of Clinical Operations of the Waters Division. "With this
 introduction we can help make a difference in the clinical laboratory by
 providing turnkey methods that have demonstrable reliability,
 reproducibility, accuracy and precision backed by the Waters Clinical
 Service team."
     For transplant patients, Therapeutic Drug Monitoring (TDM) is required
 to manage immunosuppressant therapy by determining the optimum dose for the
 individual patient. LC/MS/MS is widely used today for these measurements
 but there have been no FDA cleared methodologies with appropriate
 calibrators and controls to enable labs to routinely generate high quality
 reproducible data. This kit will enable broader adoption of LC/MS/MS by
 clinical labs by ensuring the that labs can confidently perform the assays
 and generate reliable data
     The MassTrack Immunosuppressant Kit is currently available in Europe,
 and will be available in the United States in the fall of 2007. Waters also
 has a variety of products currently under development that will continue to
 help make a difference in the clinical laboratory.
     About Waters Corporation (http://www.waters.com)
     Waters Corporation (NYSE:   WAT) creates business advantage for
 laboratory- dependent organizations by delivering practical and sustainable
 innovation to enable significant advancements in such areas as healthcare
 delivery, environmental management, food safety, and water quality
 worldwide.
     Pioneering a connected portfolio of separations science, laboratory
 information management, mass spectrometry and thermal analysis, supported
 by an expert customer services team, Waters technology breakthroughs and
 laboratory solutions provide an enduring platform for customer success.
     With revenue of $1.28 billion in 2006 and 4,700 employees, Waters is
 driving scientific discovery and operational excellence for customers
 worldwide.
     Waters and MassTrak are trademarks of Waters Corporation.
 
     Investor Contact:
     Gene Cassis
     V.P. Investor Relations
     +1 508-482-2349
     gene_cassis@waters.com
 
     Media Contact:
     Brian J. Murphy
     Public Relations
     508-482-2614
     brian_j_murphy@waters.com
 
 

SOURCE Waters Corporation

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