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FDA Clears Test to Help Patients With Kidney Transplants
Date:2/11/2011

SILVER SPRING, Md., Feb. 11, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that it 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, a drug that helps prevent rejection in kidney transplants.

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Everolimus, marketed under the trade name Zortress, was approved by FDA in April 2010 for use in adult kidney transplant patients who are at low-to-moderate immunologic risk.

Transplant patients are routinely given drugs that suppress the immune system (immunosuppressants) such as a regimen containing everolimus, cyclosporine, basiliximab, and corticosteroids. These drugs help prevent organ rejection, which occurs when the body's immune system attacks and destroys a transplanted organ.  

Some immunosuppressants are associated with toxic side effects that can injure transplanted kidneys. Balancing the levels of immunosuppressants is critical since transplant patients must take these drugs for the rest of their lives.

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

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. These tests, along with careful 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.

In addition to other evaluations, Thermofisher, t
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SOURCE U.S. Food and Drug Administration
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