FDA approves Roche's tPSA and fPSA tests:
This article was originally published in Clinica
Roche Diagnostics has gained US FDA approval for two prostate specific antigen (PSA) tests for prostate cancer. The Elecsys total PSA (tPSA) and Elecsys free PSA are automated blood tests that are run on the company's Elecsys immunoassay systems. The tPSA is a prostate cancer screening test for use in conjunction with a digital rectal examination (DRE). The fPSA is to be used with the tPSA test to calculate the ratio of fPSA to tPSA, a figure useful in distinguishing prostate cancer from benign conditions in men with an elevated PSA but a normal DRE.