Press release
- This press-release relates to the results of a European multi-centre study which was presented at the 25th annual European Association of Urology (EAU) congress, 16-20 April 2010 in Barcelona, Spain (more information)
- Professor Alexandre de la Taille of Hôpital Henri Mondor in Paris, France stated: “Previous studies have demonstrated the clinical utility of PCA3 testing in guiding repeat biopsy decisions. This study is the first to show that the PROGENSA® PCA3 Assay also can help determine whether a man suspected of having prostate cancer should undergo an initial biopsy. In addition, the study showed that PCA3 scores may indicate prostate cancer aggressiveness in this group of men”
- The study in 516 men with prostate specific antigen (PSA) levels between 2.5 and 10 ng/mL who were scheduled for an initial prostate biopsy showed that the diagnostic accuracy of the PCA3 test was statistically significantly superior to that of serum total PSA, PSA density and % free PSA. At a cut-off of 35 the PCA3 Assay had a sensitivity of 64% and a specificity of 76%
- The PCA3 Score was statistically significantly higher in men with Gleason score ≥ 7 vs. < 7, > 33% positive cores vs. ≤ 33% positive cores and significant vs. indolent cancer (according to Epstein criteria)
More information; Press release