New PSA Tests Cleared by FDA

Two new prostate-specific antigen (PSA) assays, both automated blood tests, have been cleared by the U.S. Food and Drug Administration (FDA).

The Elecsys Total PSA (tPSA) immunoassay is a screening test for use in conjunction with a digital rectal exam (DRE) as an aid in the detection of prostate cancer. Also, tPSA is used in monitoring the treatment progress of prostate cancer patients. The Elecsys Free PSA (fPSA) immunoassay is used with the Total PSA immunoassay to develop the ratio of fPSA to tPSA. This ratio is useful in distinguishing prostate cancer from benign prostate conditions in men who have an elevated tPSA but a normal DRE. A prostate biopsy is required for the diagnosis of prostate cancer.

The assays are the products of Roche Diagnostics (Basel, Switzerland; www.roche.com/diagnostics). Both are performed on Roche Elecsys immunoassay systems, available in different configurations for different healthcare settings, such as
ambulatory care centers and medium- or large-size hospitals.



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