Abbott/Wyeth drug monitoring test
This article was originally published in The Gray Sheet
Executive Summary
510(k) submission for Abbott's automated test to monitor Rapamune (sirolimus) renal transplant anti-rejection drug response is submitted to FDA under a 2003 collaboration with drug maker Wyeth. Manufacturing partner Axis-Shield is responsible for regulatory clearance. The test will run on Abbott's IMx automated immunoassay analyzer. Abbott already offers tests for cyclosporine and tacrolimus immunosuppressant monitoring. FDA currently is preparing to issue guidance outlining Class II special controls for sirolimus test systems after recently approving Microgenics' Cedia sirolimus assay via the de novo review process (1"The Gray Sheet" Aug. 23, 2004, p. 17)...