|Trade Name||PROGENSA PCA3 ASSAY|
|Classification Name||prostrate cancer genes nucleic acid amplification test system|
|Docket Number|| 12M-0173|
|Notice Date|| 03/06/2012|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the progensa pca3 assay. This device is indicated for: progensa pca3 assay is an in vitro nucleic acid amplification test. The assay measures the concentration of prostate cancer gene 3 (pca3) and prostate-specific antigen (psa) rna (rna) molecules and calculates the ratio of pca3 rna molecules to psa rna molecules (pca3 score) in post digital rectal exam (dre) first catch male urine specimens. The progensa pca3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on current standard of care, before consideration of progensa pca3 assay results. A pca3 score <25 is associated with a decreased likelihood of a positive biopsy. Prostatic biopsy is required for diagnosis of cancer.