Healthcare Industry News: Colorectal Cancer Staging Test
News Release - April 1, 2008
DiagnoCure provides update on operationsMONTREAL, April 1 (Healthcare Sales & Marketing Network) - DiagnoCure Inc. today provided an update on its Previstage(TM) GCC Colorectal Cancer Staging Test and its PCA3 test for prostate cancer. "We have recently reached some key milestones, which represent a great start for 2008 and beyond", said John Schafer, President and CEO of DiagnoCure.
Preparing for the launch of Previstage(TM) GCC
As announced earlier this year, DiagnoCure intends to launch the Previstage(TM) GCC Colorectal Cancer Staging Test this summer, through its own reference laboratory which is located in West Chester, PA. "Development of the test has now been completed in the Company's R&D facilities in Quebec City, and the test has been transferred to DiagnoCure Oncology Laboratories in West Chester", stated Mr. Schafer. DiagnoCure's team in the U.S. now includes 7 dedicated employees working on the validation and performance of the test; they are also setting up the quality and compliance procedures in order to meet the necessary regulatory requirements before the launch.
DiagnoCure has also signed a contract with Premier Source Reimbursement Solutions of South San Francisco, CA, a leading provider of reimbursement services for pharmaceutical and diagnostic companies. The services provided by Premier Source will be key to DiagnoCure's efforts to accelerate acceptance of the Previstage(TM) GCC test.
At the end of May, DiagnoCure will be exhibiting the Previstage(TM) GCC Colorectal Cancer Staging Test and DiagnoCure Oncology Laboratories at the American Society of Clinical Oncology's (ASCO) annual meeting in Chicago. The conference represents for DiagnoCure a unique opportunity to enhance the recognition of Previstage(TM) GCC testing by oncologists and other key health professionals.
The Previstage(TM) GCC test will identify the presence of occult metastases, which have been missed by traditional microscopic methods in the lymph nodes surrounding the colorectal tumor. Occult metastases are known to be a key indicator of the risk of cancer recurrence. Previstage(TM) GCC could therefore help physicians make more informed decisions in the treatment of their colorectal cancer patients.
Update on PCA3 - Pursuing discussions with Gen-Probe
Last week, DiagnoCure and Gen-Probe, the Company's PCA3 development and commercialization partner, participated in the 23rd Annual European Association of Urology (EAU) Congress that was held in Milan, Italy. Two posters specifically on the use of the PCA3 test for prostate cancer were presented, one of which provided more data supporting the clinical value of PCA3. Also, in related symposiums by Dr. Michael Marberger of Vienna, Austria, and by Dr. Jack Schalken, from Nijmegen, The Netherlands, the superior value of PCA3 over free PSA was described.
These presentations were attended by several hundred clinicians and represent a significant advance in the communication of PCA3 data to the European clinical community. The EAU audience is comprised of urologists and other healthcare specialists throughout Europe and beyond. PCA3 is a highly specific marker that can help predict the outcome of a prostate biopsy with much greater accuracy than current PSA testing. DiagnoCure owns worldwide rights to PCA3 and licensed the diagnostic rights to Gen-Probe in 2003.
Based on the agreement signed in 2003 and amended in 2006, Gen-Probe had until March 31, 2008 to submit their version of a PCA3 test to the Food and Drug Administration (FDA). Since Gen-Probe decided to hold off on a PCA3 pivotal clinical study in the United States until they can reformulate the assay to run on their investigational Panther platform, the timeline has not been met and accordingly, Gen-Probe could lose market exclusivity. DiagnoCure is pursuing constructive discussions with Gen-Probe, and is committed to achieving an outcome that will best benefit its shareholders, patients and their physicians.
DiagnoCure (TSX: CUR ) is a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services that increase clinician and patient confidence in making critical treatment decisions. DiagnoCure is currently preparing to launch the Previstage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. In 2003, the Company entered into a strategic alliance with Gen-Probe (NASDAQ: GPRO ) for the development and commercialization of a second- generation test for PCA3, DiagnoCure's proprietary molecular marker highly specific to prostate cancer. The test is now available through laboratories in the U.S. using PCA3 analyte specific reagents (ASR) from Gen-Probe, and in Europe as the CE-marked PROGENSA(TM) PCA3 in vitro assay. In addition to its own research, the Company intends to acquire or in-license additional promising cancer biomarkers from both academic and commercial institutions. 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.
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