The Access Hybritech PSA and free PSA assays in an automated, random-access platform have received FDA pre-market approval. The assays are for use on the Access Immunoassay System.
These monoclonal antibody assays, used in conjunction with a digital rectal exam, can help detect prostate cancer in men aged 50 years and older, help manage prostate cancer patients, and help differentiate between prostate cancer and benign conditions.
Both assays have a time-to-first-result of 20 minutes; 28-day curve stability; precision of <5 percent across assay ranges for both assays; analytical sensitivity of <0.005ng/mL for the free PSA assay and <0.008ng/mL for the PSA assay. The PSA assay is FDA-cleared for use in detecting and monitoring prostate cancer, and the free PSA assay is cleared to enhance the accuracy of prostate cancer detection. When a digital rectal exam is negative, the free PSA assay can help differentiate benign conditions and prostate cancer, which can reduce unnecessary biopsies for men in the diagnostic gray zone of 4 to 10ng/mL. Prostatic biopsy is required for diagnosis of cancer. Beckman Coulter
