DEVELOPMENT OF THE ABBOTT AXSYM(R) FREE PSA ASSAY - PERFORMANCE-CHARACTERISTICS AND PRELIMINARY CLINICAL-EVALUATION

The AxSYM Free PSA assay was demonstrated to have good analytical sens itivity and reproducibility. The F/T ratio determinations for 385 men tested during the Prostate Awareness Week who had biopsies due to an e levated total PSA valve and/or a suspicious DRE demonstrated that the percentage of free PSA was lower in patients found to have prostate ca ncer than those that were biopsy negative for the overall group and fo r all patient categories examined. The optimal strategy for combining PSA values, FIT ratios, DRE and other clinical and diagnostic paramete rs to improve the early detection of prostate cancer requires addition al clinical studies.