DiagnoCure reported positive data at the American Urological Association (AUA) meeting from a multicenter study to independently validate the Progensa PCA3 assay for the detection of prostate cancer in the repeat and first biopsy setting. PCA3 is a gene that is highly over‐expressed in prostate cancers. Following a digital rectal examination, the PCA3 gene can be quantified in urine specimens together with the prostate‐specific antigen (PSA) gene to generate a PCA3 score.
Of the 880 men enrolled in the study, 305 had a prior negative prostate biopsy. The results validated the initial hypothesis of the authors. Men with a PCA3 score >60 had 80% probability of a positive biopsy while those with a PCA3 score <20 had 88% probability of having a negative biopsy. PCA3 performance was superior to all other diagnostic tools tested in the study for the detection of any cancer and high grade cancers.
The Progensa PCA3 assay was approved by the FDA in February 2012 and is the first urine‐based molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.
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