Abbott, Axis-Shield Announce 510(k) of RAPAMUNE Test

Abbott has announced that its manufacturing partner Axis-Shield received 510(k) clearance from the FDA for an automated sirolimus test for monitoring the therapeutic levels of Wyeth's antirejection drug RAPAMUNE (sirolimus) in whole blood.

The IMx Sirolimus assay provides laboratories and transplant physicians with a rapid, accurate and precise method for the measurement of sirolimus levels in patients. The IMx Sirolimus assay uses microparticle enzyme immunoassay technology to measure and quantify the amount of sirolimus in a patient's blood sample. This assay utilizes Abbott's IMx System, an automated immunoassay analyzer. A benchtop system, the IMx analyzer is easy to use, allowing a laboratory to quickly train multiple operators and process multiple samples using different testing methodologies.

Last year, Abbott introduced the test in other major markets throughout the world and expects to start distributing the product in the U.S. within a few weeks.