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Gen-Probe receives FDA advisory panel notice over Progensa Assay

Gen-Probe, a commercial partner of DiagnoCure's proprietary molecular biomarker Progensa PCA3 Assay, has received a notice from the Immunology Panel of the US Food and Drug Administration's (FDA) Medical Devices Advisory Committee that the assay will not be reviewed on 14 October 2011, as previously scheduled.

The delay is made to provide the FDA with more time to review and respond to information and materials provided by Gen-Probe in connection with the Panel meeting and the premarket approval application for the Progensa PCA3 Assay.

The advisory panel said the review of the Progensa PCA3 Assay could take place in the first quarter of 2012.