FDA has approved Gen-Probe's Progensa PCA3 prostate-cancer-gene assay, the first molecular test to determine the need for repeat prostate biopsies in men who have had a negative biopsy, Reuters reports. PCA3 is a gene that is highly over-expressed in prostate cancers.
FDA approval of the assay was based on a clinical study that ran from August 2009 to May 2010. The study enrolled 495 eligible men at 14 clinical sites. In the study, the assay had a negative predictive value of 90%, meaning that a negative result predicted a negative prostate biopsy 90% of the time. 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.
The clinical study for this assay only included men who were recommended for repeat biopsy. Therefore, the performance of the assay has not been established in men for whom a repeat biopsy was not already recommended. 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.
Gen-Probe submitted its premarket approval application to FDA in August 2010.