FDA Approves Hologic Gen-Probe’s PROGENSA® PCA3 Assay,
First Urine-Based Molecular Test to Help Determine Need for Repeat Prostate Biopsies

The US Food and Drug Administration (FDA) has approved its PROGENSA PCA3 (prostate cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.

“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,” said Carl Hull, Hologic Gen-Probe’s Chairman and Chief Executive Officer. “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.”

“Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue,” said John Wei, MD, MS, Professor of Urology at the University of Michigan Health System. “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 is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on the current standard of care, before consideration of PROGENSA PCA3 assay results. A negative PROGENSA PCA3 assay result is associated with a decreased likelihood of a positive biopsy. A prostate biopsy is required to diagnose cancer.

Black Box Warning: The PROGENSA PCA3 assay should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy. Men with ASAP on their most recent biopsy should be treated in accordance with current medical guidelines.

Warning: The clinical study of the PROGENSA PCA3 assay only included men who were recommended for repeat biopsy. Therefore, the performance of the assay has not been established in men for whom a repeat biopsy was not already recommended.

FDA approval of the PROGENSA PCA3 assay was based on a clinical study that began in August 2009 and concluded in May 2010. The study enrolled 495 eligible men at 14 clinical sites. Hologic Gen-Probe submitted a Premarket Approval Application (PMA) to the FDA in August 2010.

In the clinical study, the PROGENSA PCA3 had a negative predictive value of 90%, meaning that a negative PROGENSA PCA3 assay result predicted a negative prostate biopsy 90% of the time.

About Prostate Cancer and the PROGENSA PCA3 Assay

According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six American men will get prostate cancer during his lifetime, and one in 36 will die from it. The ACS estimates that about 241,000 Americans were newly diagnosed with prostate cancer in 2011, and that approximately 34,000 men died from the disease.

PCA3 is a gene that is highly over-expressed in prostate cancers. Following a digital rectal examination, the PCA3 gene can be quantified in urine specimens together with the prostate-specific antigen (PSA) gene to generate a PCA3 score. Studies have shown that because the PCA3 gene is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional serum PSA testing in patients who have had one or more previous negative prostate biopsies.

Data from more than 80 peer-reviewed publications suggest that PCA3 gene testing, when used with other patient information, may help address some of the well-known challenges urologists face, such as identifying prostate cancers while reducing unnecessary repeat biopsies.

Hologic Gen-Probe’s PROGENSA PCA3 assay is the first urine-based molecular diagnostic assay to aid in the decision for repeat biopsy. The test has received regulatory approval and is available for sale in the United States, Canada and the European Union.

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

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