Iris International, a US based manufacturer of automated in-vitro diagnostics systems, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for NADiA ProsVue prognostic cancer test.
NADiA ProsVue is an in-vitro diagnostic assay indicated to determine the rate of change of serum total prostate specific antigen (tPSA) over a period of time.
NADiA ProsVue slope can be used as a prognostic marker in combination 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.
Iris chairman, president and CEO Cesar Garcia said the data from their multi-center clinical study supported their hypothesis that NADiA ProsVue can be useful in identifying post-prostatectomy men with reduced risk of cancer recurrence who may not need further treatment, including radiation therapy.
"We believe this prognostic assay could help patients avoid unnecessary treatment, reduce morbidity and lower the cost of management and treatment of post radical prostatectomy patients," Garcia said.