DiagnoCure’s PCA3 prostate cancer diagnostic test showcased at AUA meeting

May 25 2012

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.