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, a drug that helps prevent
rejection in kidney transplants.

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, the
manufacturer of QMS Everolimus, demonstrated the performance of the test by
comparing results from the new test to 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.

More than 87,000 patients are awaiting a kidney transplant
in the United States,
according to the Health Resources and Services Administration’s Organ
Procurement and Transplantation Network.

QMS Everolimus is manufactured by Waltham, Mass.-based
Thermofisher. Zortress is marketed by East Hanover, N.J.-based Novartis.