Health Canada grants medical device license to Gen-Probe's PROGENSA PCA3 assay

Aug 17 2011

Gen-Probe (NASDAQ: GPRO) announced today that Health Canada has granted the Company a medical device license for the PROGENSA(R) PCA3 assay, a new molecular urine test that helps determine the need for repeat biopsies in men suspected of having prostate cancer.

Gen-Probe acquired exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure (CUR: TO) in November of 2003.

"Receiving a Canadian regulatory license for the PROGENSA PCA3 assay is another important milestone in our efforts to help physicians and their patients make better, more informed decisions about whether to conduct repeat prostate biopsies in men at risk of having cancer," said Carl Hull, Gen-Probe's president and chief executive officer.

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 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.

"Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue," said Yves Fradet, MD, president, chief medical officer and co-founder of DiagnoCure and professor of surgery/urology at Universite Laval. "When evaluated alongside other risk factors, the additional insight provided by the PROGENSA PCA3 assay fills an important unmet clinical need by helping physicians conduct repeat prostate biopsies on those men who are most likely to have 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.