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NADiA® ProsVue™ is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen 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 total PSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy. 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™ assav is not intended for the diagnosis or for the monitoring of prostate cancer.

ProsVue™ is a two-site immunoassay utilizing an assay specific synthetic DNA sequence as a label with a PCR detection method. Calibrators, controls and samples react with a reagent containing a monoclonal PSA-specific antibody labeled with an assay-specific double-stranded DNA sequence. Then a reagent of paramagnetic microparticles coupled to a monoclonal antibody specific for another site on PSA is added and allowed to react to form a specific sandwich complex with PSA. After washing the particles to remove reactants, a reagent containing a heat-stable polymerase, specific primers, nucleotides, and a fluorescent dye is added to the washed microparticles. An Applied Biosystems® (AB) 7500 Fast Dx Real-Time PCR instrument is utilized to detect the presence of the monoclonal PSA-specific antibody labeled with an assay specific DNA sequence indicating the levels of PSA in the samples. PSA values of controls and samples are calculated in pg/mL from a calibrator dose-response plot. ProsVue slope is calculated using ProsVue Software from the calculated PSA concentrations of three patient samples collected between six weeks and 20 months post radical prostatectomy. The assay is made up of Reporter Antibody Reagent, Target Capture Reagent. PCR Reagent, Calibrators, Directions for Use (DFU) and ProsVue Software. Wash Reagent, Sample Diluent, and a three-level assayed control set are provided separately. ProsVue users initially receive the DFU and ProsVue software, which provide instructions and quality control support for the process of sample scheduling, collection and storage. When samples are ready for testing, the user contacts Iris Molecular Diagnostics (IMD), and IMD ships the required reagents.