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In Vitro Diagnostic Assay for Change in Prostate- Specific Antigen Over Time

TOP - October 2011 Vol 4, No 7 published on October 20, 2011 in FDA Updates

The FDA has granted 510k marketing clearance to an invitro diagnostic assay (NADiA ProsVue, Iris International) for determining rate of change of serum total prostate-specific antigen over a period of time. A slope of 3 assays is indicated for use as a prognostic marker in conjunction with clinical evaluation to aid in identifying those patients at reduced risk for recurrence of prostate cancer for the 8-year period following prostatectomy.

This nucleic acid detection immunoassay identifies extremely low concentrations of proteins that have not been routinely used as a diagnostic or prognostic aid. Clearance was based on a retrospective study of 304 patients that evaluated the slope of 3 successive tests over a period of at least 10 months after prostatectomy to identify patients with no evidence of disease or clinical progression. The assay correctly identified 92.7% of stable patients and 78.0% of patients with recurrence.

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Last modified: September 9, 2019