DiagnoCure Inc, a life sciences company that develops cancer diagnostic tests, reported that its commercial partner for the PCA3‐based test, Gen‐Probe Inc, filed on November 7, 2011, an 8‐K notice related to the review of the U.S. Food and Drug Administration (FDA) of its PROGENSA PCA3 assay. In September 2010, Gen‐Probe submitted a Premarket Approval Application (PMA) for its PROGENSA® PCA3 assay to the FDA. The company was subsequently notified by FDA that the PROGENSA PCA3 assay would be submitted for review by the Immunology Panel of FDA’s Medical Devices Advisory Committee.
On November 7, 2011, Gen‐Probe reported that it had received notice from the FDA that the FDA has concluded a panel review is no longer necessary in connection with the PMA for the PROGENSA PCA3 assay, based on recent discussions between the FDA and the company with respect to product labeling and related issues. Gen‐ Probe expects to work interactively with the FDA to address outstanding issues related to the PROGENSA PCA3 assay PMA. However, there can be no assurances as to whether the PROGENSA PCA3 assay will be approved for sale in the US on a timeline consistent with the company’s expectations, or at all.