Prostate Ca test identifies patients at reduced risk for recurrence
IRIS International, Inc. (Chatsworth, CA) has launched its prostate cancer test, NADiA ProsVue.
IRIS International, Inc. (Chatsworth, CA) has launched its prostate cancer test, NADiA ProsVue.
The test received 510(k) clearance from the FDA and Conformité Européenne Mark approval in the fall of 2011.
NADiA ProsVue is an in vitro diagnostic assay for determining rate of change of serum total PSA over a period of time. A retrospective clinical study of 304 patients evaluated the slope of three successive ProsVue tests over a period of at least 10 months after a prostatectomy to identify prostate cancer patients with no evidence of disease or clinical progression. Recurrence of disease was determined by positive imaging, biopsy results, or prostate cancer-related death.
The study resulted in a negative predictive value of 92.7% and a positive predictive value of 78%. Consequently, a ProsVue slope of equal to or less than 2.0 pg/mL per month in the first year following radical prostatectomy was highly associated with no evidence of disease over the long-term follow-up.
"NADiA ProsVue could mark a significant change in the way we care for and manage prostate cancer patients," said Judd Moul, MD, of Duke University Medical Center, Durham, NC. "Many men who may not be at a high risk for clinical recurrences currently receive adjuvant therapy after surgery, which often leads to complications such as impotence and incontinence. NADiA ProsVue results provide clinicians with an important new tool to help determine those patients that may not benefit from additional therapy and can avoid the effects of unnecessary treatment."
Dr. Moul is a paid consultant for IRIS International, Inc.
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