Clinical Research Laboratories Now Have New Kit for Tacrolimus, Sirolimus, Everolimus, and Cyclosporin A Measurement

Waters Corporation (NYSE:WAT) today introduced a new kit for the quantification of Tacrolimus, Sirolimus, Everolimus, and Cyclosporin A by clinical research laboratories. The Waters® MassTrak™ Immunosuppressant XE RUO Kit is optimized for use with Waters TQD System, MassLynx™ 4.1 software control and TargetLynx™ Application Manager. Not intended for diagnostic purposes, the kit can be used by research laboratories affiliated with university or urban hospitals that perform research associated with transplant centers. The kit was introduced at the AACC Annual Meeting and Clinical Lab Expo, July 19 – 23 in Chicago and is available from Waters worldwide.

The MassTrak Immunosuppressants XE RUO Kit features isotopically-labelled internal standards (Everolimus and Cyclosporin A) to facilitate accurate quantitative determinations. Each kit also includes calibrants and controls for performing up to 500 determinations. Coupled with the Waters LC/MS/MS system the kit can quantify the target parent drugs without interference from the drug metabolites.

Cyclosporin A, Tacrolimus, Sirolimus and Everolimus are the four most common immunosuppressive drugs given to kidney, heart, liver, lung transplant patients to minimize organ rejection. Failure to adequately control the drug concentrations within a narrow therapeutic window can lead to rejection of the transplanted organ or cause toxic side effects. The MassTrak Immunosuppressants XE RUO Kit allows laboratories to perform comparative studies against routine tests, feasibility studies or other research studies such as evaluating optimal drug exposure markers.

Increasingly, these drugs are being used in combination, and at lower concentrations. Analyzing these four drugs with one method and one kit enables laboratories to optimize their workflow and reduce operating costs.

For almost 20 years, Waters products have met the needs of clinical laboratories, transplant hospitals and reference laboratories in the areas of therapeutic drug monitoring, disease management, endocrinology, and toxicology. In 2007, the Waters MassTrak Immunosuppressants Kit was cleared by the U.S. Food and Drug Administration (FDA) for the quantification of tacrolimus in human whole blood to aid in the therapy of kidney and liver transplant patients.