FDA advisory panel for PROGENSA PCA3 delayed

FDA advisory panel for PROGENSA PCA3 delayed

PR Newswire

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.

About DiagnoCure

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.

Forward‐looking statements

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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