This complexed prostatate specific antigen (cPSA) assay has been cleared for use on the Advia Centaur and ACS:180 Immunoassay systems as an aid in the detection of prostate cancer in conjunction with a digital rectal exam (DRE). The cPSA assay is also indicated as an aid in the management of patients with prostate cancer.
The complexed PSA is bound to protein in the blood. Concentrations of cPSA are higher in men with prostate cancer. A study cited in the FDA submission showed that the cPSA test and the total PSA test are comparable in their ability to detect prostate cancer when they are used in combination with DRE. The study also showed that cPSA in combination with DRE detects significantly more cancers than DRE alone.