Leading Clinicians Highlight Value of PCA3 Testing at Europe's Largest Urology Event
QUEBEC CITY, Feb. 29, 2012 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR), a Quebec life sciences company that develops and commercializes high‐value cancer diagnostic tests, announced that PROGENSA® PCA3 prostate cancer diagnostic test has been featured in seven presentations by leading professors and researchers at the 27th annual European Association of Urology (EAU) congress in Paris. PROGENSA® PCA3 assay was approved by the FDA on February 15 and is the first urine‐based molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. The test is marketed by GenProbe, DiagnoCure's commercial partner.
"The level of interest in the clinical utility and cost-benefit of the PCA3 test is increasing steadily" said Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure, who attended the meeting. "The recent FDA approval has been perceived as a strong signal of the value of the test in the management of men investigated for a high PSA blood test."
PROGENSA® PCA3 was one of the main items of discussion in a plenary session at EAU devoted to screening, diagnosis and treatment of early stage prostate cancer. During the session, Professor Alexandre de la Taille from the urology service of the Henri Mondor hospital in Creteil, France, highlighted PROGENSA® PCA3 as a possible solution that could overcome the limitations of current medical practice for screening and diagnosis. One of the challenges of testing for prostate cancer today is that as many as 1,000 men are screened and up to 250 must undergo a biopsy in order to save a single life. Routine PCA3 testing could reduce this burden on patients and healthcare systems. Professor de la Taille presented data from a multi-center European study showing that, if a PCA3 test was performed before an initial biopsy, as many as 40% men with high PSA could be saved a biopsy. In these patients, only 2% of high grade cancers were missed using the same 25 PCA3 score cut-off on which the FDA has agreed for testing men with a previously negative biopsy.
Professor de la Taille also presented the results from the clinical trial that led to the recent U.S. approval of PCA3 in men with a previous negative prostate biopsy. Based on the FDA recommended use of PROGENSA® PCA3, a test score of 25 or less provides a 90% probability of a negative biopsy and saves as many as 50% of repeat biopsies. During his presentation, Professor de la Taille expressed the opinion that the FDA approval may potentially have a positive impact on the reimbursement of the PCA3 test in European countries. The PROGENSA® PCA3 test is commercialized in Europe under CE mark.
PCA3 testing was the topic of 6 other presentations during the EAU meeting. One of them, presented by Professor Bertrand Tombal from the urology service of the Université catholique de Louvain in Bruxelles, Belgium, also demonstrated that PCA3 can reduce repeat biopsies while maintaining the ability to detect high grade cancer. The PCA3 test significantly outperformed a panel of 12 leading urologists presented with clinical data from a 1000 patient study designed to predict patients most likely to have a positive repeat biopsy.
The Annual EAU Congress, which took place in Paris February 24-28, is Europe's largest urology event and serves as a platform for the international urological community to share the latest and the most relevant knowledge with medical experts practicing across the board. This year's meeting was attended by approximately 14,000 urologists from more than 130 countries.
About Prostate Cancer and the PROGENSA PCA3 Assay
According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six American men will get prostate cancer during his lifetime, and one in 36 will die from it. The ACS estimates that about 241,000 Americans were newly diagnosed with prostate cancer in 2011, and that approximately 34,000 men died from the disease.
PCA3 is a gene that is highly over-expressed in prostate cancers. Following a digital rectal examination, the PCA3 gene can be quantified in urine specimens together with the prostate-specific antigen (PSA) gene to generate a PCA3 score. Studies have shown that because the PCA3 gene is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional serum PSA testing in patients who have had one or more previous negative prostate biopsies.
Data from more than 80 peer-reviewed publications suggest that PCA3 gene testing, when used with other patient information, may help address some of the well-known challenges urologists face, such as identifying prostate cancers while reducing unnecessary repeat biopsies.
Gen-Probe's PROGENSA PCA3 assay is the first urine-based molecular diagnostic assay to aid in the decision for repeat biopsy. The test has received regulatory approval and is available for sale in the United States, Canada and the European Union.
DiagnoCure granted Gen-Probe exclusive worldwide diagnostic rights to the PCA3 gene in November 2003. Gen-Probe plans to formally launch PROGENSA® PCA3 assay in 2012. Under the terms of the agreement, DiagnoCure will initially receive 8% royalties on sales, increasing to 16% after $62.5 million cumulative sales, of which about half has been reached to date.
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 in Europe under CE mark and is now approved for commercialization in Canada and the United States. 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.
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