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FDA Panel Delays Review of Gen-Probe's Progensa PCA3 Assay

NEW YORK (GenomeWeb News) – A US Food and Drug Administration panel will not review Gen-Probe's submission for clearance of its Progensa PCA3 assay for prostate cancer in October as previously scheduled, the San Diego-based company disclosed in a regulatory filing after the close of the market Monday.

In the Form 8-K filed with the US Securities and Exchange Commission, Gen-Probe said that the Immunology Panel of FDA's Medical Devices Advisory Committee postponed its review until a later date in order to have additional time to review and respond to new information and materials the company submitted in connection with its premarket approval application for the assay. The Progensa PCA3 assay is for determining whether repeat biopsies are necessary for men suspected of having prostate cancer.

A new date has not been set, but Gen-Probe said it expects a review to take place during the first quarter of 2012.

Gen-Probe submitted its PMA application for the Progensa PCA3 assay in September 2010. The assay is CE marked and received regulatory approval in Canada two weeks ago.

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