More than 2,400 men tested in largest worldwide studies to date
QUEBEC CITY, March 8 /CNW Telbec/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced that the clinical utility of the PROGENSA(R) PCA3 test, developed and commercialized by its partner Gen-Probe (NASDAQ: GPRO), was confirmed in two large worldwide studies, conducted in a subset of patients in GlaxoSmithKline's REDUCE trial of dutasteride. The results demonstrate that PCA3 can help determine whether men suspected of having prostate cancer should undergo a repeat biopsy and can predict the risk of having an aggressive cancer. The studies were presented last week at the American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO GU) in San Francisco.
"This four-year multicenter worldwide study is the largest to date performed on DiagnoCure's PCA3 marker. It shows that the test can be useful in managing patients suspected of having prostate cancer. For doctors and patients struggling with the dilemma of the traditional PSA test that has a well-known low specificity, the PCA3 test, with a specificity of up to 80% (depending on the cut-off), can offer a more reliable answer. These results indicate that the PCA3 test can help reduce unnecessary prostate biopsies and help identify patients that have a more aggressive cancer, representing a step forward in personalized patient care," said Dr Yves Fradet, co-founder and President of DiagnoCure.
In the studies presented at the ASCO GU meeting, PCA3 was used to test urine samples from men enrolled in the REDUCE trial of GlaxoSmithKline's drug dutasteride. PCA3 testing was done on urine samples from 1,140 men in the placebo arm of the REDUCE trial, and from 1,308 men treated with dutasteride. All men underwent prostate biopsies two and four years after enrollment in the study.
The first PCA3 study presented at the meeting originated from the placebo arm of the REDUCE trial. This study, which was highlighted in ASCO's official press program, showed that PCA3 scores were significantly correlated with a positive prostate biopsy result, and that men who had higher PCA3 scores were more likely to have prostate cancer. Specifically, cancer was diagnosed in only 6% of men with very low PCA3 scores, but in 57% of men with very high PCA3 scores.
PCA3 scores also correlated with cancer aggressiveness (as defined by the Gleason Score): median PCA3 scores were higher in men with high-grade cancers than in those with low-grade cancers. Finally, the PCA3 test also predicted the likelihood of a positive prostate biopsy performed two years after the test.
The second PCA3 study originated from the patients treated with dutasteride in the REDUCE trial. This study demonstrated that PCA3 also can be used to predict prostate biopsy outcomes in men taking dutasteride. It confirmed earlier research that showed PCA3 outperforms serum PSA testing for prostate cancer detection, and improves diagnostic accuracy when combined with serum PSA testing and other clinical information.
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., launched in 2008 the Previstage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. A major study published in the February 18, 2009, edition of the Journal of the American Medical Association demonstrated that GCC, to which DiagnoCure owns exclusive worldwide diagnostic rights, is the strongest independent predictor of colorectal cancer recurrence. More clinical studies are underway to confirm the clinical utility of the Previstage(TM) GCC test. The Company 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 available through laboratories in the U.S. using PCA3 analyte specific reagents (ASR) from Gen-Probe, in Europe as the CE-marked PROGENSA(R) PCA3 in vitro assay, and in Canada. A clinical study aimed at securing FDA approval for the commercialization of PROGENSA(R) PCA3 test in the U.S. is underway. 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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