Thermofisher QMS test for kidney transplants wins FDA clearance

The US Food and Drug Administration (FDA) has cleared Thermofisher's test, QMS Everolimus Immunoassay, to help manage potential organ rejection in kidney transplant patients.

Thermofisher said the test monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants.

QMS Everolimus is one of a number of FDA-cleared or -approved tests physicians can use to monitor and manage immunosuppressant levels, including tests for cyclosporine, tacrolimus, and sirolimus.

The tests, along with monitoring of clinical signs and symptoms of organ rejection, tissue biopsies, and other lab tests, may increase the chance of having a successful transplant and possibly extend the survival of a transplanted kidney.

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

Thermofisher has demonstrated the performance of the test that 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.