Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its Thermo Scientific QMS Everolimus Assay Kit has been CE marked for sale in the European Union for a third application, namely liver transplants. This new indication allows laboratories to monitor blood levels of everolimus, the active ingredient in the drug Certican® (manufactured by Novartis Pharmaceuticals) in liver transplant patients. Previously, the QMS® Everolimus Assay Kit was CE marked for kidney and heart transplant applications. In the United States, the QMS Everolimus Assay Kit has U.S. Food and Drug Administration (FDA) clearance for use in monitoring kidney transplant patients. Thermo Fisher Scientific was the first company to offer a CE marked and FDA cleared assay for monitoring everolimus in kidney transplant patients.
The QMS® Everolimus Assay Kit rounds out Thermo Fisher Scientific's menu of immunoassays for immunosuppressant drugs including cyclosporine, tacrolimus, and mycophenolic acid.
Thermo Fisher Scientific has a proven track record for supplying high-quality reagents, calibrators and controls that dates back to 1989. The company's homogeneous immunoassay products have been used in many major clinical laboratories and drug testing facilities around the world. The ready-to-use, liquid QMS assays are used on automatic clinical chemistry analyzers as part of therapeutic drug monitoring, an integral part in organ transplant recipient treatment programs.
Thermo Scientific QMS Everolimus Calibrator and Control sets are also available for use with the QMS Everolimus Assay. The calibrator kit contains six different calibrators to complete a full six-point calibration as part of the test procedure; the QMS Everolimus Control Set contains three levels.