Test for Monitoring Transplant Drug

A new test is designed for monitoring the therapeutic levels of the anti-rejection drug sirolimus (Rapamune) in the whole blood of kidney transplant patients. The test has been cleared by the U.S. Food and Drug Administration (FDA).

The sirolimus test, which monitors a drug developed by Wyeth Pharmaceuticals (Collegeville, PA, USA), is manufactured by Axis-Shield (Dundee, Scotland), the manufacturing partner of Abbott Laboratories (Abbott Park, IL, USA). Abbott and Axis-Shield entered into a joint agreement in 2003 to develop a sirolimus test that could be run on Abbott's IMx and other automated immunoassay systems. Abbott has introduced the test in major markets throughout the world and expects to start distributing the product in the United States soon.

The IMx sirolimus assay uses microparticle enzyme immunoassay (MEIA) technology to measure and quantify the amount of sirolimus in a patient's blood sample. A benchtop system, the IMx analyzer allows a laboratory to quickly train multiple operators and can process multiple samples using different testing methodologies.

Sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older who are receiving renal transplants. It is recommended that sirolimus be used initially in a regimen with cyclosporine and corticosteroids. In patients at low-to-moderate immunologic risk, cyclosporine should be withdrawn two to four months after transplantation and the sirolimus dose should be increased to reach recommended blood concentrations. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only doctors experienced in immunosuppressive therapy and management of renal transplant patients should use sirolimus.

"Since drugs that require management work best within a specific range, monitoring blood levels is an important part of treatment,” explained Douglas C. Bryant, vice president, global commercial operations, Diagnostics Division, Abbott. "With this assay, many hospital laboratories will now be able to process patient samples in-house and provide results to doctors within hours, potentially improving patient care.”


Related Links:
Abbott
Wyeth Pharma