Clinical Utility

The PCA3 Test measures both PCA3 and PSA mRNA in a urine sample collected following a DRE (Digital Rectal Examination). The PSA mRNA measurement ensures that prostate cells were collected in the sample and also provides a means to normalize the PCA3 mRNA amount. The result is reported as a ratio of PCA3 mRNA to PSA mRNA, which translates to a low or high risk of having prostate cancer.

The measured PCA3/PSA ratios allow us to establish the risk of having a positive biopsy. The risk is expressed either as low or high. PSA mRNA measurements below a certain detection amount will produce an inconclusive test, indicating that insufficient prostate cells were detected.

  • The Assay detects the over expression of the PCA3 gene which is specific for prostate cancer.
  • Genekor’s PCA3 test quantifies the mRNA of the PCA3 gene in urine using the molecular technique TMA.
  • It is not affected by the size of the prostate or possible prostate infections.
  • It is approved by the FDA and is included in the European Association of Urology (EAU) guidelines for deciding whether or not a repeat biopsy is necessary.
  • The higher the PCA3 score, the greater the probability of a positive biopsy.

Understanding the Result