Gen-Probe (NASDAQ:GPRO) said Wednesday it has obtained regulatory approval from Health Canada for its molecular diagnostic test, Progensa PCA3, used to verify the need for repeat biopsies in men at risk of getting prostate cancer.
Gen-Probe acquired worldwide diagnostics rights to the biomarker Prostate Cancer Antigen 3 (PCA3) gene from DiagnoCure (TSE:CUR) in 2003.
The PCA3 assay predicts results more accurately than the traditional prostate-specific antigen testing method, said Gen-Probe.
According to studies, an elevated PCA3 score is associated with an increased likelihood of a positive biopsy.
"Receiving a Canadian regulatory license for the Progensa PCA3 assay is another important milestone in our efforts to help physicians and patients make better decisions about whether to conduct repeat prostate biopsies," said Gen-Probe CEO, Carl Hull.
The PCA3 gene test - carried out through urine samples taken after a digital rectal examination – is highly over-expressed in more than 90% of prostate cancers. The test is the first urine-based molecular diagnostic test for prostate cancer.
Health Canada granted the medical device license based on an August 2009 clinical study performed on 507 men. The study concluded in May of last year, after which Gen-Probe submitted its license application to Health Canada in December 2010.
In Canada, the Progensa PCA3 test will be used alongside other patient information or risk factors to aid in the decision for repeat biopsy in men aged 50 or older, who have had one or more previous negative prostate biopsies.
The test is marked for sale in the European Union, while a regulatory application has been submitted to the U.S. FDA.
Prostate cancer usually consists of several primary tumours located in the prostate. If left untreated, prostate cancer cells may continue to grow and could spread to other parts of the body and produce secondary tumours.
According to the Canadian Cancer Society, prostate cancer is the most common type of cancer among Canadian men. In 2011, it is estimated 25,500 Canadian men will be diagnosed with prostate cancer, and 4,100 will die of it.
San Diego, California-based Gen-Probe, founded in 1983, makes testing products used for clinical diagnosis of human diseases and for screening donated human blood.
The company’s shares jumped 79 cents to $61.61 Wednesday morning on the Nasdaq exchange.