PCA3 Test Featured at American Urological Association Meeting

May 25, 2012, 07:30 ET from DIAGNOCURE INC.

DiagnoCure Management Responds to USPSTF Recommendation on Prostate Cancer Screening

Ticker Symbol: CUR

QUEBEC CITY, May 25, 2012 /PRNewswire/ - DiagnoCure Inc. (TSX: CUR), a Quebec life sciences company that develops and commercializes high-value cancer diagnostic tests, reported that the PROGENSA PCA3 prostate cancer diagnostic test has been featured in a number of presentations and discussions at the American Urological Association (AUA) meeting in Atlanta, GA. The value of PCA3 testing was highlighted during a debate on the new USPSFT recommendation on prostate cancer screening. PCA3 testing was the topic of 14 presentations during the meeting.

USPSTF Recommendation on Prostate Cancer Screening - Implications for PROGENSA PCA3 Test

On Monday May 21, the US Preventive Services Task Force (USPSTF) issued its final recommendation against the routine use of prostate-specific antigen (PSA)-based screening for prostate cancer. The Task Force has stated that PSA testing results in little or no reduction in prostate cancer-specific mortality and is associated with harms related to subsequent evaluation and treatments, some of which may be unnecessary. The recommendation applies to asymptomatic men in the general U.S. population, regardless of age, but does not include the use of the PSA test for surveillance after diagnosis or treatment of prostate cancer. The recommendation has been publicly criticized by the American Urological Association. The issue was debated by leading urologists during a "Town Hall" meeting at the AUA meeting earlier this week.

DiagnoCure management believes that the USPSTF recommendation may have positive implications for the use of the PROGENSA PCA3 test. The PCA3 urine test provides an opportunity to reduce the harm of PSA screening by reducing the number of unnecessary biopsies while identifying the lethal cancers. This argument in favor of PROGENSA PCA3 testing was made during a presentation at the AUA meeting by Dr. John Wei, professor at the University of Michigan.

Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure commented, "These opposing views of the USPSTF and the AUA, as well as the ongoing debate in clinical community on the most effective way to screen for prostate cancer, highlight the great need for a test like PCA3 to reduce the burden of PSA screening while maintaining the progress made in fighting this number one cancer in men."

Clinical Data on PROGENSA PCA3

On Wednesday May 23, Dr. Wei presented results of a PROGENSA PCA3 trial conducted by the NCI Early Detection Research Network (NCI-EDRN). This was a multicenter study from 11 clinical US centers, with the objective of completing a comprehensive and independent validation of the PROGENSA PCA3 Assay for the detection of prostate cancer both in the repeat and first biopsy setting. A total of 880 eligible men were enrolled, including 305 who had a prior negative prostate biopsy. Men with a PCA3 score >60 had 80% probability of a positive biopsy while those with a PCA3 score <20 had 88% probability of having a negative biopsy. The results validated the initial hypothesis of the authors. PCA3 performance was superior to all other diagnostic tools tested in the study for the detection of any cancer and high grade cancers. The authors believe those results, which are significant improvements over classical diagnostic tools, will allow PCA3 to greatly enhance clinical decision making.

The 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 Gen-Probe, DiagnoCure's commercial partner.

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. 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.

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 in Europe under CE mark and is now approved for commercialization in Canada and the United States. 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.