Prism release
This article was originally published in The Gray Sheet
Executive Summary
Abbott's Prism automated blood supply testing platform was launched Oct. 13 following FDA approval of the HBcore assay, the system's first test menu option, for hepatitis core antigen. Additional hepatitis and HIV assays are currently under agency review. The Prism platform has been available outside of the U.S. for over 10 years, but the firm's 1999 consent decree delayed the approval of assay products produced at its Lake County, Ill. manufacturing facility (1"The Gray Sheet" May 20, 2002, p. 17). Units have already been shipped to 10 blood bank customers...