Product category:
Clinical chemistry analysis
News Release from: Waters | Subject: MassTrak
Edited by the Laboratorytalk Editorial
Team on 18 July 2007
Drug monitoring kit wins FDA clearance
Along with Waters LC/MS systems and its clinical service and support, the kit provides a complete validated solution for transplant centres wishing to perform tacrolimus therapeutic drug monitoring
Waters is introducing its MassTrak immunosuppressant kit for the monitoring of tacrolimus levels in kidney and liver transplant patients at the 2007 AACC annual meeting and Clinical Lab Expo in San Diego this week The kit, which recently received clearance from the US 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
This article was originally published on Laboratorytalk on 2 Aug 2004 at 8.00am (UK)
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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, says the company.
"At Waters, we understand and recognise that for customers to realise 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.
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