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Immunosuppressant Kit facilitates tacrolimus monitoring.

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August 1, 2007 - Along with liquid chromatography (LC)/mass spectrometry (MS) systems and clinical service and support, MassTrak(TM) provides complete validated solution for transplant centers wishing to perform tacrolimus therapeutic drug monitoring. Solution, FDA approved for use with LC/MS/MS, quantifies immunosuppressant tacrolimus in kidney and liver transplant patients. It combines controls, calibrators, internal standard, and HPLC column with methodology for consistent, reproducible measurements.

Waters Introduces Groundbreaking MassTrak Immunosuppressant Kit at AACC


(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)

Waters Corporation
34 Maple St.
Milford, MA, 01757
USA



Press release date: July 13, 2007

New Therapeutic Drug Monitoring Kit Is First to Receive Clearance from the FDA for Use with LC/MS/MS

MILFORD, Mass., July 13 - At the 2007 AACC Annual Meeting and Clinical Lab Expo, July 15-19, in San Diego, Waters Corporation (NYSE:WAT)(NYSE:AACC)(NYSE:Booth)(NYSE: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.
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