Waters Introduces MassTrak Immunosuppressant Kit at AACC
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At the 2007 AACC Annual Meeting and Clinical Lab Expo, July 15 - 19, in San Diego, CA, Waters Corporation is introducing its MassTrak™ 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 said to be 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.
The MassTrack Immunosuppressant kit is currently available in Europe, and will be available in the United States in the fall of 2007.