Prostate-Specific Antigen Blood Test for Prostate Cancer

The prostate-specific antigen test is now a routine component of cancer screening programs. The test allows for earlier detection, monitoring of treatment response and prediction of disease recurrence. Elevated levels of prostate-specific antigen in the blood suggest enlargement or tumors of the prostate, which can be confirmed by ultrasound test and biopsy. Since prostate tumors can grow quickly and spread to other parts of the body, early detection is critical.

The FDA approved the first PSA test in 1986 for monitoring patients already diagnosed with prostate cancer. A pivotal study in the April 25, 1991, issue of the New England Journal of Medicine established that the PSA test, combined with rectal examination or ultrasonography, provides an effective method of detecting prostate cancer. In August 1994, the FDA approved the Tandem^® brand PSA test for use with rectal examination to aid detection of prostate cancer in men age 50 and older.

Many companies now make PSA products including: Abbott Laboratories’ AxSYM^® PSA Assay and IMx^® PSA Assay; Hybritech Incorporated’s Tandem^®-R PSA and Tandem^®-E PSA; Ciba Corning Diagnostics Corporation’s ACS; and the Bayer Corporation’s Technicon Immuno 1^® System.