IRIS International has unveiled the results of a multi-center clinical study using its proprietary NADiA ProsVue prognostic prostate cancer test in 304 post-radical prostatectomy patients treated at four clinical sites and followed for up to 17.6 years for clinical recurrence post-radical prostatectomy.
IRIS said the NADiA molecular diagnostics platform uses real-time Polymerase Chain Reaction (PCR) systems to measure low concentrations of proteins, which are under the detection threshold of current immunoassay methods.
Results of IRIS’ proprietary ultra-sensitive NADiA ProsVue test were compared with the outcome of documented clinical recurrence following radical prostatectomy.
The ProsVue test was able to quantify PSA levels in all patient samples.
The clinical study demonstrated that patients with a ProsVue linear slope of less than or equal to 2 pg/mL per month within the first year following radical prostatectomy are at greatly reduced risk of prostate cancer recurrence and was highly associated with no evidence of disease in up to 17.6 years of follow-up.
IRIS chief technology officer Thomas Adams said compared with Gleason score and traditional factors in the multivariate analysis, ProsVue slope was the strongest independent predictor in the model.
"Potential clinical utility may include identification of patients not requiring long-term oncologic treatment, or a lack of need for adjuvant radiation therapy, a high cost procedure associated with significant morbidity," Adams said.
The ProsVue test is pending the US Food and Drug Administration (FDA) 510(k) clearance and the permissible claims and product launch in the US depend on the terms and timing of any clearance.
It is contemplated that IRIS’s CLIA-certified molecular diagnostics laboratory, Arista Molecular, will be the exclusive ProsVue provider upon attainment of the US Food and Drug Administration clearance.