On Wednesday, the US Food and Drug Administration (FDA) approved Gen-Probe’s PROGENSA® PCA3 (Prostate Cancer gene 3) assay, the first molecular test to help determine whether men with a previous negative biopsy need a repeat biopsy.

Carl Hull, Gen-Probe’s Chairman and Chief Executive Officer said:

“When used in conjunction with other diagnostic information, our PROGENSA PCA3 assay provides clinically important information that helps physicians and their patients make better, more informed decisions about one of the most vexing problems in prostate cancer diagnosis. From a commercial perspective, this is the third of four potential US regulatory approvals that we expect to generate a significant new sales growth cycle for the Company.”

John Wei, MD, MS, Professor of Urology at the University of Michigan Health System explains:

“Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue. When evaluated with other risk factors, the PROGENSA PCA3 assay fills an important unmet clinical need by helping physicians identify which men suspected of having prostate cancer should undergo a repeat prostate biopsy.”

The PROGENSA PCA3 assay has been designed for use in combination with other patient information, to help doctors decide whether a repeat biopsy in men aged 50 years or above, with one or more previous negative prostate biopsies is necessary, as well as for those, whose urologist had recommended a repeat biopsy based on the current standard of care, prior to considering PROGENSA PCA3 assay results. Negative PROGENSAPCA3 assay results are linked to a lower likelihood of a positive biopsy. To diagnose cancer, doctors need to perform a prostate biopsy.

Important Safety Information

The PROGENSA PCA3 assay is not intended for use in men, whose most recent biopsy revealed an atypical small acinar proliferation (ASAP). These patients should receive treatment according to current medical guidelines.

Given that the clinical study of the PROGENSA PCA3 assay was conducted only in those recommended for repeat biopsy, the performance of the assay has not been proven in men without a recommended repeat biopsy.

After Gen-Probe submission for Premarket Approval Application (PMA) in August 2010, the FDA granted PROGENSA PCA3 assay’s approval based on a clinical study of 495 eligible men at 14 clinical sites, which started in August 2009 and concluded in May 2010. The clinical study showed a negative predictive value of 90% using PREOGENSA PCA3. This means that a negative PROGENSAPCA3 assay result predicted a negative prostate biopsy 90% of the time.

About Prostate Cancer and the PROGENSA PCA3 Assay

In the U.S., prostate cancer is the second most common type of cancer after skin cancer, and has the second-highest cancer mortality after lung cancer, according to the American Cancer Society (ACS). It is estimated that one in six American men will develop prostate cancer during their lifetime, with one in 36 men dying from the disease. Further ACS estimations show that in 2011, 241,000 new cases of prostate cancer have been diagnosed and around 34,000 men died from the disease.

Because the PCA3 gene is highly over-expressed in prostate cancer, doctors can quantify the gene in urine specimens together with the prostate-specific antigen (PSA) gene to produce a PCA3 score after a digital rectal examination. Research has proven that due to the fact that the PCA3 gene is highly specific to prostate cancer, it more accurately predicts the results of repeat biopsies compared with traditional serum PSA testing in patients with one or more previous negative prostate biopsies.

According to data from over 80 peer-reviewed publications, PCA3 gene testing in combination with using other patient information, may assist urologists in addressing some of the well-known challenges like identifying prostate cancers whilst reducing unnecessary repeat biopsies.

Gen-Probe’s PROGENSA PCA3 assay, which has been granted regulatory approval and is available for sale in the United States, Canada and the European Union, is the first urine-based molecular diagnostic assay that helps doctors in deciding whether or not a repeat biopsy is necessary.

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

Written by Petra Rattue