Reflex method for the detection of prostate cancer

G - Physics – 01 – N

Patent

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G01N 33/574 (2006.01) G01N 33/53 (2006.01) G01N 33/573 (2006.01)

Patent

CA 2311512

A method for aiding in the detection of prostate cancer in male human patients, e.g., for differentiating prostate cancer from the normal condition and from benign prostate diseases such as prostate hypertrophy (BPH) and prostatitis, by a reflex method in which complexed prostate specific antigen (cPSA) is first measured in a blood sample from a male patient, and if the patient's cPSA blood level is greater than an upper limit of normal (e.g., between about 2 and about 4 ng/mL), total PSA (tPSA) is then measured in the sample and the proportion of the measured tPSA amount that is the measured cPSA amount is determined. The cut-off for the proportion of cPSA to tPSA can be set to provide an indication that the patient is not at risk for prostate cancer (e.g., less than about 82%), or to provide an indication that the patient is at risk for prostate cancer (e.g., greater than about 83 %). This c + c/t reflex method has been found to provide an improved method for the detection of prostate cancer, eliminating the need for a significant number of patients to undergo unnecessary prostate biopsy.

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