The Corporation has granted a worldwide exclusive license on PCA3
for the development and commercialization of a prostate cancer test which is now commercialized in Europe under CE mark and is approved for commercialization in Canada and the United States.
testing is most useful when repeated over a period of time to monitor for changes in the observed value.
Clinical utility of the PCA3
urine assay in European men scheduled for repeat biopsy.
Evaluation of PCA3
in postattentive prostate massage urine samples with transcription-mediated amplification technology has shown to be superior to serum PSA determination in predicting biopsy outcome, with sensitivity and specificity approximating 70% and 80%, respectively, and a negative predictive value of 90% (248-251); it is currently under evaluation for FDA approval in the United States.
Testing for TMPRSS2:ERG and PCA3
significantly improves the ability to predict whether a man has prostate cancer," said lead author Scott Tomlins, M.
Performance of the prostate cancer antigen 3 (PCA3
) gene and prostate-specific antigen in prescreened men: exploring the value of PCA3
for a first-line diagnostic test.
Personally I think it's criminal that this non-invasive and more accurate PCA3
test is not available on the NHS.
Up to 100 times more PCA3
is present in these cells than in non-cancerous cells.
In a notice posted March 7, 2006, to its official website, the United States Patent and Trademark Office has indicated that it has granted a patent on the PCA3
gene technology, which encompasses both therapeutic and diagnostic applications.
DiagnoCure has developed a first-generation version of a PCA3
DD3 test that is offered in the United States as an analyte specific reagent.
The strong association between PCA3
mRNA overexpression and malignant transformation of prostate epithelium indicates its potential as a diagnostic biomarker.
The experience with a tumor biomarker, the PCA3
[prostate cancer gene 3 (non-protein coding)] gene, illustrates the long and winding road that must be navigated.