Common clinical practices for the characterization and risk assessment of PCa utilize serum prostate-specific antigen (PSA) and DRE as indications for biopsy. However, in several high profile studies, the low specificity of serum PSA for PCa (i.e., false positive results) has been shown to lead to unnecessary biopsies and to significant issues of over-detection and over-treatment. Moreover, in about 20 percent of cases, prostate biopsy can miss malignancies, leading physicians to conduct many unnecessary repeat biopsies in an effort to avoid missing cancer. The Progensa PCA3 assay -– an FDA-approved prostate cancer testing solution designed to detect the prostate cancer gene 3 (PCA3), which is known to be highly specific for prostate cancer –- is independent of serum PSA and other commonly used predictive measures. The additional clinical information provided by the PCA3 assay can assist physicians and patients in making better repeat biopsy decisions by helping balance the fear of missing cancer with the risks and adverse effects associated with the prostate biopsy procedure, some of which can be very serious.
The Progensa PCA3 assay, an in vitro nucleic acid amplification test, measures the concentration of PCA3 and PSA RNA molecules in male urine specimens. The assay calculates the ratio of PCA3 RNA molecules to PSA RNA molecules to generate a PCA3 score. Studies have shown that because the PCA3 gene is highly specific for prostate cancer, the Progensa PCA3 score 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. In fact, in the clinical study conducted prior to Hologic submitting a Premarket Approval Application (PMA) to the FDA, the Progensa PCA3 had a negative predictive value of 90%, meaning that a negative Progensa PCA3 assay result predicted a negative prostate biopsy 90% of the time. When evaluated with other risk factors, the Progensa PCA3 assay fills an important unmet clinical need by helping physicians identify which men suspected of having prostate cancer should undergo a repeat prostate biopsy.
For the most current information on the clinical performance and utility of the Progensa PCA3 assay, please visit www.PCA3.org.*
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