FDA clears test to manage potential kidney transplant rejection

March 3, 2011

The FDA has cleared a test to help manage potential organ rejection in kidney transplant patients.

The FDA has cleared a test to help manage potential organ rejection in kidney transplant patients.

The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus (Zortress), a drug that helps prevent rejection in kidney transplants.

"QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus," said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

Thermofisher, the manufacturer of QMS Everolimus, demonstrated the performance of the test by comparing results from the new test with the results from everolimus reference tests used in the clinical trial of everolimus. When the clinical trial blood samples were tested with QMS Everolimus, the results, on average, were similar to those of the clinical trial reference test.