The PROGENSA PCA3 Assay is approved by the US Food and Drug Administration (FDA) for the following use

Intended Use

The 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 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.

Black Box Warning: The PROGENSA PCA3 Assay should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy. Men with ASAP on their most recent biopsy should be treated in accordance with current medical guidelines.

Warning: The Clinical Study only included men who were recommended by urologists for repeat biopsy. Therefore, the performance of the PROGENSA PCA3 Assay has not been established in men for whom a repeat biopsy was not already recommended.