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.