The US Food and Drug Administration (FDA) has approved the Access Hybritech p2PSA (Beckman Coulter) test, which measures a form of prostate-specific antigen (PSA) called [-2]proPSA in the blood and can help men whose PSA test scores are elevated decide whether they should have a biopsy to rule out prostate cancer.
The Access Hybritech p2PSA test is approved for use in men aged ≥50 years whose PSA test score is between 4 and 10 ng/mL but a digital rectal examination does not show any signs of cancer. A PSA test score between 4 and 10 ng/mL often prompts physicians to recommend a prostate biopsy.
The FDA approval was based on a clinical trial with nearly 660 men, of whom approximately half had prostate cancer. The phi score was better than the PSA score at distinguishing between benign conditions and pros - tate cancer. In addition, the study showed that the phi score level was a predictor of cancer, with a higher score associated with increased probability of detecting prostate cancer after a biopsy.
According to Barry Kramer, MD, Director of the National Cancer Institute Division of Cancer Prevention, the study was not designed to determine whether the phi test reduces the risk of dying from prostate cancer.
There is, however, no standard phi score that points out whether to have a biopsy. According to the FDA, “The choice of an appropriate…phi score to be used in guiding clinical decisionmaking may vary for each patient and may depend in part on other clinically important factors or on family history of disease.”
The Access Hybritech p2PSA is expected to be available in the United States this year, according to the manufacturer. (June 14, 2012)
