The US Food and Drug Administration (FDA) has granted 510(k) clearance for IRIS Internationals' Nucleic Acid Detection Immunoassay (NADiA) ProsVue prognostic cancer test.
NADiA technology combines immunoassay and real-time PCR methodologies to detect cancer proteins with femtogram/millilitre sensitivity.
The approval is based on a retrospective clinical study of 304 patients that evaluated the slope of three successive ProsVue tests over a period of at least ten months after a prostatectomy, to identify prostate cancer patients with no evidence of disease or clinical progression.
The study resulted in a negative predictive value - the proportion of patients correctly identified as stable - of 92.7%.
The positive predictive value - the proportion of patients correctly identified as recurring - was 78%.
A ProsVue slope of equal to or less than 2.0pg/ml per month in the first year, following radical post-prostatectomy shows no evidence of disease over the long-term follow up.
ProsVue test also determines the rate of change of serum total prostate specific antigen over a period of time.
IRIS International chairman president and CEO César García said that the data from the multicentre clinical study showed 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," García added.