FDA advisory panel for PROGENSA PCA3 delayed
QUEBEC CITY, Aug. 29, 2011 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company that develops and commercializes high‐value cancer diagnostic tests, announced today that Gen-Probe Incorporated, its commercial partner for the PCA3 test, received notice from the U.S. 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.
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 en 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.
SOURCE DIAGNOCURE INC.
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