Abbott Laboratories, through a collaboration with Wyeth, announced that its manufacturing partner, Axis-Shield, has submitted a 510(k) Premarket Notification with the US FDA seeking clearance of a sirolimus test for use on Abbott's IMx System.

Widely used in hospital laboratories throughout the world, the IMx automated immunoassay analyzer is a benchtop system that is easy-to-use, providing quick turnaround times for patient samples, and features an extensive testing menu. Rapamune (sirolimus), a Wyeth anti-rejection drug, is an immunosuppressant agent indicated for renal transplants. In August, Abbott introduced the IMx Sirolimus assay in other major markets throughout the world, abbott said in a release.

"Abbott has a strong history in providing assays to monitor therapeutic drugs, especially in the area of transplant diagnostics," said William Brown, vice president, Diagnostic Assays and Systems Development, Abbott Laboratories. "These tests are vital to helping doctors manage patient care and an important part of the treatment process," he added.

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.

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.