QUEBEC CITY, Nov. 8, 2011 /CNW Telbec/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company that develops and commercializes high‐value cancer diagnostic tests, today reported that its commercial partner for the PCA3-based test, Gen-Probe Incorporated (NASDAQ: GPRO), 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 United States on a timeline consistent with the company's expectations, or at all.
DiagnoCure (TSX: CUR) is a life sciences company that develops and commercializes high-value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Company launched the PrevistageTM GCC Colorectal Cancer Staging Test through its U.S. CLIA laboratory, and granted the worldwide exclusive rights to this test to Signal Genetics in June 2011. The Company also has a strategic alliance with Gen-Probe (NASDAQ: GPRO) for the development and commercialization of a second-generation prostate cancer test using PCA3, DiagnoCure's proprietary molecular biomarker. The PROGENSA® PCA3 test is commercialized in Europe under CE mark and was recently approved in Canada; in the United States, the test is commercialized through clinical laboratories using PCA3 analyte specific reagents from Gen‐Probe; a PMA application was filed with the FDA. For more information, visit www.diagnocure.com.
This release contains forward‐looking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. By their very nature, forward‐looking statements are based on expectations and hypotheses and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure's control. As a result, investors are cautioned not to place undue reliance on these forward‐looking statements. The forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues are based on management expectations. In addition, the reader is referred to the applicable general risks and uncertainties described in DiagnoCure's most recent Annual Information Form under the heading "Risk Factors". DiagnoCure undertakes no obligation to publicly update or revise any forward‐looking statements contained herein unless required by the applicable securities laws and regulations.