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Abbott Prism Assays, Spectrum Of Product Launches Stalled By QSR Finding

This article was originally published in The Gray Sheet

Executive Summary

Approval of Abbott Laboratories' Prism hepatitis B core antibody and HIV-1/2 assays likely will be delayed by FDA's finding that Abbott's Lake County, Illinois diagnostic manufacturing facility still does not comply with quality system regulations, the firm said

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Prism release

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...

Prism release

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...

Abbott

FDA review of firm's Feb. 8 response to agency observations at Abbott's Lake County, Illinois facility is expected to be completed in April following an FDA request to extend its review by 45 days. Abbott's response covers both the final audit stipulated in the firm's 1999 consent decree with FDA and the pre-approval inspection by FDA's Center for Biologics Evaluation and Research related to Abbott's Prism assays, company reps note. Abbott is counting on resolution of the consent decree and FDA sign-off on the firm's high-throughput automated blood screening system assays to boost diagnostic sales in 2002 (1"The Gray Sheet" Jan. 21, 2002, p. 9)...

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