DiagnoCure Inc, a life sciences company that develops and commercializes cancer diagnostic tests, and Gen‐Probe Inc, its commercial partner for the PCA3 test, received notice from the US Food and Drug Administration (FDA) that the PROGENSA® PCA3 Assay will not be reviewed by the Immunology Panel of FDA’s Medical Devices Advisory Committee on October 14, 2011, as previously scheduled, but will be reviewed by the panel at a later date. Gen‐Probe was informed that the panel review has been postponed in order to provide the FDA more time to review and respond to information and materials that have been provided by Gen‐Probe in connection with the panel meeting and the Premarket Approval Application for the PROGENSA PCA3 Assay. A new date for the panel review of the PROGENSA PCA3 Assay has not yet been confirmed, but Gen‐Probe informed DiagnoCure that it currently expects that it could take place in the first quarter of 2012.
Source: DiagnoCure Inc
