-Positive PROGENSA® PCA3 Results Presented at the Recent AUA Meeting Demonstrate High Specificity-
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Last Friday, DiagnoCure, Inc. (TSX: CUR) issued a press release announcing that the PROGENSA® PCA3 prostate cancer diagnostic test was featured at the American Urological Association (AUA) meeting. PROGENSA® PCA3 is marketed by Gen-Probe, DiagnoCure’s exclusive licensee for diagnostic applications of PCA3. Also in the release, the Company addressed the recent controversial headline news from the US Preventative Services Task Force (USPSTF).
Gen-Probe’s PROGENSA® PCA3 Assay Featured at Recent AUA Meeting – Results Demonstrate High Specificity. A total of 14 presentations discussing the utility of the PROGENSA® PCA3 diagnostic test were presented at the recent AUA meeting in Atlanta, GA. During these presentations, the value of PCA3 testing was highlighted. At the AUA meeting on Wednesday May 23, 2012, Dr. Wei presented the results of a multicenter clinical study with 11 US sites that was conducted by the NCI Early Detection Research Network (NCI-EDRN). The objective of the study was to complete an independent validation of the PROGENSA® PCA3 diagnostic assay in the repeat and first biopsy settings. 880 men were enrolled (305 or 35% had a prior negative biopsy) and the results demonstrated that men with a PCA3 score of greater than 60 had an 80% chance of a positive biopsy, while men with a PCA3 score less than 20 had an 88% probability. We believe these results validated the author’s initial hypothesis and that the objective of the study, which was to provide an independent validation of the diagnostic assay, was accomplished. Also during the meeting, a debate discussing the recent USPSTF recommendation on prostate cancer screening took place.
USPSTF Recommends Against Screening for Prostate Cancer. On May 21, the USPSTF issued a controversial recommendation, which gave a D recommendation and recommended against the routine use of prostate-specific antigen (PSA)-based screening for prostate cancer in men. Importantly, the recommendation applies to asymptomatic men in the general US population, regardless of age, race, or family history, but does not include the use of the PSA test for surveillance after diagnosis or treatment of prostate cancer.