NADiA ProsVue is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen (tPSA) over a period of time (slope, pg/mL per month). The NADiA ProsVue assay is performed for patients having less than 0.1 ng/mL serum tPSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy.
The NADiA ProsVue slope is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy.†
The NADiA ProsVue assay is not intended for the diagnosis or for the monitoring of prostate cancer.
†"Recurrence” is defined as clinical recurrence, not biochemical recurrence, and was documented by positive imaging, positive biopsy, or death due to prostate cancer.