The AxSYM Free PSA assay was demonstrated to have good analytical sensitivity and reproducibility. The F/T ratio determinations for 385 men tested during the Prostate Awareness Week who had biopsies due to an elevated total PSA value and/or a suspicious DRE demonstrated that the percentage of free PSA was lower in patients found to have prostate cancer than those that were biopsy negative for the overall group and for all patient categories examined. The optimal strategy for combining PSA values, F/T ratios, DRE and other clinical and diagnostic parameters to improve the early detection of prostate cancer requires additional clinical studies.