Healthcare Industry News: Evista
News Release - August 26, 2008
DiagnoCure receives approval from the U.S. regulatory authorities and launches its Previstage(TM) GCC Colorectal Cancer Staging TestQUEBEC CITY, Aug. 26 (HSMN NewsFeed) - DiagnoCure Oncology Laboratories, based in West Chester, PA, a wholly-owned subsidiary of DiagnoCure Inc., announced today that it has received the U.S. CLIA certification required for the Company to launch its new laboratory developed PrEvistage(TM) GCC Colorectal Cancer Staging Test. The sales team can now actively promote the test, and the Company's U.S. clinical laboratory can perform it and report patient results worldwide.
"Receiving this regulatory certification is a major accomplishment in DiagnoCure's growth strategy, which will strengthen our leadership position in high-value molecular cancer diagnostics. We can now provide clinicians and patients with a test using a technology that is 100,000 fold more sensitive than the current method of staging. We can help answer the fundamental question that every colorectal cancer patient asks after their surgery: Am I cured or has my cancer spread?", stated John Schafer, President and CEO of DiagnoCure.
DiagnoCure Oncology Laboratories will promote and offer the test directly to clinicians across the United States. Following the summer pre-launch marketing campaign, several physicians have already expressed interest in the test.
About PrEvistage(TM) GCC
Every year in North America, 174,000 people are diagnosed with colorectal cancer, and 142,000 colorectal cancer surgeries are performed. Staging a patient with colorectal cancer is crucial because it determines the patient's course of treatment after the surgery. Current standard of care requires that pathologists microscopically examine a thin slice of tissue from the lymph nodes harvested during the patient's surgery to see if cancer has spread. Currently, up to 25 - 30 percent of patients with no pathologically-positive lymph nodes (stage I and II cancers) later develop recurrent disease, presumably through occult metastases that have escaped detection. Most of these patients do not receive additional therapies such as chemotherapy. PrEvistage(TM) GCC provides clinicians with significantly more accurate information for staging a patient with colorectal cancer that will increase their confidence in making critical treatment decisions.
Strong data supports the potential for the GCC test to improve the current staging of colorectal patients. The National Cancer Institute sponsored a five-year prospective clinical trial of GCC testing in colorectal cancer patients. This study has been recently completed and the Company's collaborators at Thomas Jefferson University are presenting the results at major medical conferences throughout the year.
The PrEvistage(TM) GCC Colorectal Cancer Staging Test is a laboratory-developed test and its performance characteristics have been validated and determined by DiagnoCure Oncology Laboratories.
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 Oncology Laboratories, a subsidiary of DiagnoCure Inc., recently launched the PrEvistage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. 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 marker. This test is also available through laboratories in the U.S. using PCA3 analyte specific reagents (ASR) from Gen-Probe, in Europe as the CE-marked PROGENSA(TM) PCA3 in vitro assay, and in Canada. 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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