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PSA Standardization

Clinical Differences in PSA Screening14

Slide 26

October 2009

In a study from 2004 that was one of the first clinical reports of the impact of PSA standardization, over 2000 men were tested with the Hybritech assay and two other WHO standardized assays.  The study found that the WHO assays yielded results that were 23% lower.  Using a cutoff of PSA greater than 4.0 ng/mL, 57 patients (2.5%) would have been candidates for biopsy based on Access but not Centaur data. If a lower cutoff of PSA greater than 2.5 ng/mL had been used, this number would have increased to 107 patients (4.6%). If all men who had a PSA greater than 2.5 ng/mL were considered, 19% of those individuals would have a PSA that was at or above the 4.0 ng/mL cut-off.  This represents a “high prevalence of cancer” group and is dramatically similar to the 18% figure derived from the data seen on the previous slide.

Clinical Differences


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