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news.Gen-Probe, a commercial partner for DiagnoCure's PCA3 test, has obtained a notice from the US Food and Drug Administration (FDA) that the PROGENSA PCA3 assay will not be reviewed as previously scheduled.
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The delay was made in order to provide the FDA more time to review and respond to information and materials that have been provided by Gen-Prob in connection with the Panel meeting and the Premarket Approval Application for the PROGENSA PCA3 Assay.
Gen-Probe informed DiagnoCure that it currently expects that the review could take place in the first quarter of 2012.