NEW YORK (GenomeWeb News) – Gen-Probe and DiagnoCure said today that Gen-Probe has received a regulatory medical device license from Health Canada, the Canadian government's department responsible for national public health, for a molecular urine test that determines the need for repeat biopsies for prostate cancer.
Gen-Probe exclusively licensed the worldwide rights to the PCA3 gene, on which its Progensa PCA3 assay is based, from its commercial partner DiagnoCure in 2003.
The PCA3 gene is highly over-expressed in more than 90 percent of prostate cancers and is highly specific for this type of cancer, Gen-Probe and DiagnoCure said, adding that the gene predicts the results of repeat biopsies more accurately than PSA testing.
In Canada, the Progensa PCA3 assay has been indicated for use in conjunction with other patient information to assist in the decision on taking a repeat biopsy for men ages 50 and older and who have had one or more previous negative prostate biopsies.
Gen-Probe and DiagnoCure said that it received the approval based on a multicenter clinical study of 507 men in 2009-2010, and it applied for the license in December.
The test has been CE-marked for sale in the European Union and a regulatory application has been submitted to the US Food and Drug Administration for sale in the US. It is scheduled to be reviewed by the FDA Immunology Devices Panel in October.