This test uses the Siemens' ADVIA Centaur cPSA methodology, which is FDA approved for use as an aid in the detection of prostate cancer in men age 50 and older when used in conjunction with a digital rectal exam. This methodology is also approved as an aid in the management/monitoring of prostate cancer patients. Results obtained with different assay methods or kits cannot be used interchangeably. Prostatic biopsy is required for the diagnosis of cancer. cPSA is generally not elevated in healthy men or with non-prostatic carcinoma. cPSA concentrations may be elevated in benign prostatic hyperplasia or inflammatory conditions of the prostate. Prostate cancer patients under treatment with antiandrogens and LHRH agonists and antagonists may exhibit markedly reduced levels of cPSA. Care should be taken when interpreting values from these individuals.