Patent ID: 7211397

Claim:
A method to aid in distinguishing prostate cancer from benign prostate disease in a subject, comprising the steps of: a) determining the amount of total PSA contained in a serum or plasma sample from the subject; b) determining the amount of free PSA in the sample; and calculating the ratio of the free PSA to the total PSA; c) determining the amount of inPSA in the sample; and d) correlating the amount of inPSA contained in the sample to the presence of prostate cancer in the subject by comparing the amount of inPSA to a predetermined value established with control samples of known cancer and benign disease diagnosis, based on both the level of total PSA and the ratio of the free PSA to the total, wherein inPSA is equal to free PSA minus BPSA and pPSA; e) distinguishing prostate cancer from benign prostate disease in the subject based on the correlation in step d).