Navigation Links
Waters CE Marks In Vitro Diagnostic MassTrak Immunosuppressants XE Kit

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.


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.  

The instrumentation and kit is currently only available for sale in the European Economic Area and Switzerland.

Organ Transplantation Now More Common as Medical Science Extends Life Expectancy of Patients

According to a report released by Kalorama Information,(1)  approximately 70,000 organ transplant surgeries are performed worldwide each year with most patients requiring lifelong immunosuppressant therapy to prevent rejection. Today tacrolimus, in combination with mycophenolate mofetil (MMF) is the standard of care for organ transplantation.

Immunosuppressant drugs help to prevent organ rejection by suppressing the immune system of patients with donor kidneys, livers, hearts, and other organs. Treating transplant patients requires skill on the part of the surgeons and the transplant team and compliance on the part of the patient. Transplant recipients must take these drugs for life and are closely monitored for side-effects and toxicity. Every transplant patient is unique and many factors influence the rate at which these drugs are absorbed, metabolized, utilized, and eliminated. Other influencing factors are the patient's age, genetic background, general state of health and other drugs they may be taking.

Monitoring immunosuppressant drug concentrations is crucial for successful patient outcomes. If the concentration level of the immunosuppressant is too low, the patient is at risk of organ rejection. If the level in the bloodstream is too high, then toxicity can occur. Other conditions such as pregnancies, temporary illnesses, emotional and physical stressors, accidents, and surgeries all play a role in how patient levels of the immunosuppressants are managed over time. As such, regular monitoring of patients becomes vital to their health and well-being over time. Regular monitoring also assures patient compliance.

LC/MS in the Clinical Laboratory

For a long time, immunoassays have been the technique of choice for monitoring transplant patients. One of the inherent deficiencies of the immunoassay technique is the potential to cross-react with drug metabolites which, in turn, may lead to the overestimation of the parent drug concentration.

With advances in analytical techniques, LC/MS/MS is now a well-established technology for immunosuppressant drug monitoring.  Since 1990, internationally-convened consensus groups have called for the use of analytical procedures for therapeutic drug monitoring (TDM) that are specific for the active parent compound.  

The Waters MassTrak Immunosuppressants XE Solution is specific for the parent drugs tacrolimus and everolimus and measures concentrations of the parent drugs independent of the level of known metabolites in patient samples. Other benefits include increased sensitivity and precision at the low end of the dosing range, and the potential to lower consumable and operating costs relative to established immunoassay methods.

About Waters Corporation (

For over 50 years, Waters Corporation (NYSE: WAT) has created business advantages 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, Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success.

With revenue of $1.64 billion in 2010 and 5,400 employees, Waters is driving scientific discovery and operational excellence for customers worldwide.

(1) Organ Transplant Immunosuppressive Markets, Kalorama Information, Jan. 1, 2008

Waters, ACQUITY, ACQUITY UPLC, UPLC, and MassTrak are trademarks of Waters Corporation. Prograf is a registered trademark of Astellas Pharma. Certican is a registered trademark of Novartis AG.

SOURCE Waters Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Waters Introduces Ostro Sample Preparation Products
2. Waters Expands Xevo MS Instrument Platform With Next-Generation Mass Spectrometers
3. Waters Corporation and NIBRT Partner to Bring Greater Control and Predictability to Biopharmaceutical Processing
4. Waters SDMS Vision Publisher Now Certified Compliant with SAFE-BioPharma Digital Standard
5. New Analytical Training Lab Standardizes on Waters Innovative Technologies to Achieve Educational Goals
6. Aprima Earns High Marks at Holy Name Medical Center
7. DecisionView to Create Clinical Trial Enrollment Benchmarks
8. Carl Marks Advises Scovill Fasteners in Sale of Company
9. Oncology Global Strategic Marketing Study Offers Chance for Resource Benchmarks
10. Stretch Marks the Spot
11. CSL Behring Marks World Hemophilia Day with Coagulation Factor Donation to World Federation of Hemophilia
Post Your Comments:
(Date:11/27/2015)... UTRECHT , Niederlande, November 27, 2015 /PRNewswire/ ... mit fotodynamischer Bremachlorin-Therapie bei fortgeschrittenem Krebs.   ... fotodynamischer Bremachlorin-Therapie bei fortgeschrittenem Krebs.   --> ... fotodynamischer Bremachlorin-Therapie bei fortgeschrittenem Krebs.   ... berichtet. --> Clinical Cancer Research ...
(Date:11/26/2015)... Países Bajos, November 26, 2015 ... fotodinámica de Bremachlorin para el cáncer avanzado.   ... con la terapia fotodinámica de Bremachlorin para el cáncer ... enfoque combina la inmunoterapia con la terapia fotodinámica de ... Clinical Cancer Research . --> Clinical Cancer ...
(Date:11/26/2015)... -- Research and Markets ( ) has announced the ... to 2019 - Rise in Cardiac Disorders and Growing Awareness ... their offering. Boston scientific ... scientific and others. --> The market is ... Boston scientific and others. ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... The print ... USA Today in Atlanta, Dallas, New York, Minneapolis, South Florida, with a circulation ... is distributed nationally, through a vast social media strategy and across a network ...
(Date:11/27/2015)... ... November 27, 2015 , ... Consistent ... sharing, the 2016 Building Better Radiology Marketing Programs meeting will showcase ... Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a pre-conference ...
(Date:11/27/2015)... ... November 27, 2015 , ... The moment you stop improving ... only fulfilling the needs of advisers and clients but going above and beyond ... top-tier customer service. However, there's always room for improvement, which is why the ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... the largest, most successful and prominent nonprofit healthcare organizations in the country. They ... involvement with various organizations, and helped advance the healthcare industry as a whole ...
(Date:11/27/2015)... ... November 27, 2015 , ... Indosoft ... announces the incorporation of Asterisk 11 LTS (Long Term Support) into its Q-Suite ... LTS brings Q-Suite 5.10 up-to-date with a version of Asterisk that will receive ...
Breaking Medicine News(10 mins):