Atlanta – Waters Corporation (WAT:NYSE) today unveiled new technology solutions for increasing clinical laboratory efficiencies including the first CE Marked LC/MS/MS integrated solution for the quantification of everolimus (Certican®).

Being displayed in Waters booth #3136 are these exciting new products.

• MassTrak™ Online Solid Phase Extraction Analyzer providing automated sample clean-up, concentration, and extraction complemented by Waters® ACQUITY® TQD tandem quadrupole mass spectrometer for high-sensitivity quantitative analysis.

• MassTrak Immunosuppressants XE Kit – CE marked in accordance with the IVD Directive 98/79/EC for the quantification of tacrolimus (FK506;Prograf®) in liver and kidney transplant patients and everolimus (Certican®)

Educational Workshops

This year, Waters is sponsoring two scientific workshops which are designed to further the education of laboratory technicians, scientists, and chemists responsible for developing, implementing, and maintaining robust clinical assays. Each workshop features presentations from leading practitioners in the field of clinical chemistry.

• Good Method Development and Validation Practices for Liquid Chromatography – Mass Spectrometry (LC-MS), Tuesday, July 26, 6 – 7:30 p.m., Hyatt Regency Atlanta, Regency Ballroom VII. Featured presenters: John W. Honour, Ph.D., University College London Hospitals, London, UK; Kimberly Napoli Eaton, Ph.D., Laboratory Director, Andor Laboratories, LLC, Durham, NC; and Graham Carter, DEQAS Organiser, Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK. Attendees at this workshop may be eligible to receive ACCENT® educational credit hours.

• Implementing LC/MS/MS in the Clinical Laboratory, Wednesday, July 27, 6 – 7:30 p.m., Hyatt Regency Atlanta, Centennial Ballroom III. Featured presenters: Elizabeth L. Frank, Ph.D. DABCC, Associate Professor of Pathology, University of Utah Health Science Center, Salt Lake City, UT; Shannon Harmond, Ph.D., Director – Clinical Chemistry Laboratory, Children’s Memorial Hospital, Chicago, IL; Paul J. Jannetto, Ph.D., DABCC, Associate Professor of Pathology, Medical College of Wisconsin, Milwaukee, WI.

Scientific Posters

Waters scientists and customers will be presenting several scientific posters at AACC including:

• Everolimus Measurement: Evaluating the Waters MassTrak Immunosuppressant XE Kit for use with LC/MS/MS

• Development of a Rapid Quantitative/Semi-Quantitative LC/MS/MS Method to Monitor Opioids and Glucuronide Metabolites

• Measurement of 25-Hydroxyvitamin D3 and C3-epi-25-Hydroxyvitamin D3 Using UPLC/MS/MS in Pediatric and Adult Populations

• Evaluation of LC/MS/MS Scrambling Ratios for Deuterium-Labeled Vitamin D Metabolites, Steroids and Other Compounds of Clinical Significance

• Development of an LC/MS/MS Method for 1,25 Dihydroxy Vitamin D for Use in the Clinical Laboratory

About Waters Clinical Business Operations (https://www.waters.com/waters/nav.htm?&cid=10009130&locale=en_US)

Working with clinical and forensic toxicology laboratories around the world, Waters has pioneered an integrated portfolio of MassTrak Solutions that include separations science, mass spectrometry, consumables, laboratory information management software, services and application support. Waters’ comprehensive approach optimizes the implementation of LC/MS/MS assays in the laboratory. MassTrak Solutions bring the power of Waters technologies, including tandem mass spectrometry, in easy-to-use cost effective packages addressing therapeutic drug monitoring for everolimus and tacrolimus and for forensic toxicology. Waters innovations and laboratory solutions provide improved accuracy and precision for laboratory assays that help ensure quality results. Waters is committed to helping laboratories deliver quality results with improved levels of sample throughput, shortened turnaround times as well as increased sensitivity, specificity and flexibility.

About Waters Corporation (https://www.waters.com)

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.

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

Waters CE Marks In Vitro Diagnostic MassTrak Immunosuppressants XE Kit

Putting LC/MS/MS to Use for Therapeutic Drug Monitoring of Tacrolimus and Everolimus in Transplant Patients

Atlanta – July 25, 2011 – Waters Corporation (WAT:NYSE) 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 (https://www.waters.com)

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, https://www.kaloramainformation.com/Organ-Transplant-Immunosuppressive-1399527/

For more information on Waters ACQUITY UPLC products:

https://www.waters.com/waters/nav.htm?locale=en_US&cid=10125009

For more information on Waters ACQUITY TQD system:

https://www.waters.com/waters/nav.htm?locale=en_US&cid=514467