FDA Advisory Board to review Gen-Probe’s PCA3 test next year


The possibility of approval of the Progensa® PCA3 test here in the USA any time soon appears to have received a setback.

According to a media release from DiagnoCure — a Canadian company that developed the test in association with U.S.-based Gen-Probe — the U.S. Food & Drug Administration (FDA) has delayed the scheduled review of Progensa by the immunology panel of it’s Medical Devices Advisory Committee. This review was originally scheduled for October 14, 2011 but has now been postponed “to provide the FDA more time to review and respond to information and materials that have been provided by Gen‐Probe.”

Gen‐Probe has advised DiagnoCure that it expects a rescheduled advisory board meeting some time in the first quarter of 2012.

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