Health Canada has granted Gen‐Probe, the commercial partner of DiagnoCure Inc for the PCA3 biomarker, a medical device license for the PROGENSA® PCA3 assay, a new molecular urine test that helps determine the need for repeat biopsies in men suspected of having prostate cancer.
In Canada, the PROGENSA PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years or older who have had one or more previous negative prostate biopsies. An elevated PCA3 score is associated with an increased likelihood of a positive biopsy. A prostate biopsy is required for the diagnosis of cancer.
Gen‐Probe received Health Canada licensure for the PROGENSA PCA3 assay based on a prospective, multicenter clinical study of the assay that enrolled 507 men. The trial began in August of 2009 and concluded in May of 2010. Gen‐Probe submitted a Medical Device License Application to Health Canada in December of 2010.
The PROGENSA PCA3 assay is currently under review by the FDA. On October 14, 2011, the test will be reviewed by an FDA Immunology Devices Panel, which is responsible for providing advice and recommendations to the FDA on the premarket approval application of the PROGENSA PCA3 assay.