Gen-Probe submits amendment to BLA for Procleix Ultrio assay

By Lisa Kerner

Erie, Pa., March 31 - Gen-Probe Inc. said it submitted to the Food and Drug Administration an amendment to its Biologics License Application for the Procleix Ultrio assay on the Procleix enhanced semi-automated system (eSAS).

The amendment is in response to the FDA's October 2005 "complete review letter" regarding the Ultrio assay, according to a company news release.

In September 2004, Gen-Probe filed its original BLA for the Ultrio assay, which is approved for commercial blood screening in countries outside the United States.

Gen-Probe said it developed the Ultrio assay to simultaneously detect human immunodeficiency virus type 1 (HIV-1), hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissues.

The company plans to submit 510(k) applications for its Procleix Tigris system to run the Procleix WNV assay, a blood screening test for the West Nile virus, and the Ultrio assay.

The WNV assay is already FDA-approved to run on the eSAS.

Located in San Diego, Gen-Probe develops, manufactures and markets nucleic acid tests used to diagnose human diseases and screen donated human blood.

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