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, 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.