Abbott Laboratory's manufacturing partner Axis-Shield received 510(k) clearance from the US FDA for an automated sirolimus test for monitoring the therapeutic levels of Wyeth's anti-rejection drug Rapamune in whole blood.

This assay utilizes Abbott's IMx System, an automated immunoassay analyzer widely-used in hospital laboratories throughout the world. The IMx Sirolimus assay provides laboratories and transplant physicians with a rapid, accurate and precise method for the measurement of sirolimus levels in patients. Last year, Abbott introduced the test in other major markets throughout the world and expects to start distributing the product in the United States within a few weeks.

"To help reduce the risk of organ rejection, transplant patients are given a regimen of immunosuppressant agents that require ongoing therapeutic drug monitoring. Since drugs that require management work best within a specific range, monitoring blood levels is an important part of treatment," Douglas C. Bryant, vice president, Global Commercial Operations, Diagnostics Division, Abbott said adding, "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."

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 is easy-to-use, allowing a laboratory to quickly train multiple operators and can process multiple samples using different testing methodologies.

"Sirolimus has become an important therapeutic choice for doctors performing renal transplants. Having this new sensitive and reliable assay for sirolimus will make it easier for doctors caring for transplant patients to help optimize the patient's therapy," said Joseph S. Camardo, senior vice president, Global Medical Affairs, Wyeth Pharmaceuticals.

In 2003, Abbott and Wyeth entered into a joint agreement to develop a sirolimus test for use on Abbott's IMx and other automated immunoassay systems. Abbott's manufacturing partner Axis-Shield plc, based in Dundee, Scotland, manufactures the test that Abbott distributes.

Rapamune is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants.

Axis-Shield is a global manufacturer of in vitro diagnostic kits with a focus on new markers in cardiovascular, rheumatoid, infectious and alcohol-related diseases, diabetes, dementia and near patient testing to facilitate improved patient management. Axis-Shield has partnered with Abbott to introduce several new tests on both the IMx and AxSYM systems, Abbott's market-leading automated immunoassay analyzers.