FDA Clears Complexed PSA Test for Prostate Cancer

A complexed prostate specific-antigen (cPSA) test has been cleared by the U.S. Food and Drug Administration (FDA) as an aid in the detection of prostate cancer. The test is designed to be run on the Immunol system of Bayer Diagnostics (Tarrytown, NY, USA).

Serum PSA has proven to be an extremely useful marker for early detetection of prostate cancer and in monitoring patients for disease progression and the effects of treatment. Deaths from prostate cancer are declining and prostate cancer survival rates are increasing. The survival rate for all stages combined has increased from 67%-89% over the past twenty years. This increase is mainly due to increasing awareness of prostate cancer among doctors and the general public and earlier PSA testing.

"We note that recent published literature on this new marker demonstrates that cPSA can replace traditional total PSA testing as an aid in detecting prostate cancer,” said Dr. William Wallen, Ph.D., senior vice president, Bayer Diagnostics.