PROGENSA(R) PCA3 Assay Can Help Predict Outcome of Initial Prostate Biopsies, According to Study Presented at Leading Urology Meeting

SAN DIEGO, April 22 /PRNewswire/ -- Gen-Probe's (Nasdaq: GPRO) PROGENSA® PCA3 assay can help predict the outcome of initial prostate biopsies in men suspected of having prostate cancer, according to a study of the molecular urine test presented in a scientific poster last week at the 25th annual European Association of Urology (EAU) Congress in Barcelona, Spain.

PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers.

"Previous studies have demonstrated the clinical utility of PCA3 testing in guiding repeat biopsy decisions," said Professor Alexandre de la Taille of Hopital Henri Mondor in Paris, France.  "This study is the first to show that the PROGENSA PCA3 assay also can help determine whether a man suspected of having prostate cancer should undergo an initial biopsy.  In addition, the study showed that PCA3 scores may indicate prostate cancer aggressiveness in this group of men."

In the multi-centre study, PCA3 testing was performed on urine samples from 516 men with prostate specific antigen (PSA) levels between 2.5 and 10 ng/mL who were scheduled for an initial prostate biopsy.  Approximately 40% of these biopsies were positive.  Key study results included:

• The diagnostic accuracy of the PROGENSA PCA3 test, as measured by a statistical technique known as AUC ROC, was maximized by using a PCA3 score of 35 as the cut-off between normal and elevated levels.  At this cut-off, the assay had a sensitivity of 64%, a specificity of 76%, and an AUC ROC of 0.761.
• The diagnostic accuracy of the PCA3 test was statistically superior to that of serum total PSA (P<0.0001), PSA density (P=0.0232) and % free PSA (P<0.0001).
• Men with PCA3 scores above 35 were 2.7 times more likely to have a positive biopsy than men with PCA3 scores below 35 (P<0.0001).
• The higher the PCA3 score, the greater the probability of a positive biopsy.  For example, cancer was diagnosed in only 20% of men with very low PCA3 scores (N=56), but in 78% of men with very high PCA3 scores (N=54).
• PCA3 scores correlated with measures of prostate cancer aggressiveness.  Specifically, mean PCA3 scores were statistically higher in men with Gleason scores greater or less than 7 (P<0.0001), in men with >33% positive biopsy cores (P<0.0001), and in men with "significant" versus "indolent" cancers, as measured by Epstein criteria (P=0.0016).

About Prostate Cancer and PCA3

According to the European Prostate Cancer Coalition, prostate cancer is one of the most common cancers among European men.  More than 300,000 new cases of prostate cancer are diagnosed annually in the European Union, and more than two million Europeans are living with the disease.

PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination.  Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing.

Data from approximately 30 peer-reviewed publications suggest that PCA3 testing, when used with other patient information, may help address some of the well-known challenges urologists face when identifying prostate cancer, such as identifying clinically relevant cancers that need to be treated while minimizing unnecessary biopsies.

Gen-Probe's PROGENSA PCA3 assay, which has been CE-marked for sale in the European Union, is the first urine-based molecular diagnostic assay for prostate cancer.

In August of 2009, Gen-Probe initiated a clinical trial intended to secure U.S. regulatory approval of the PROGENSA PCA3 assay, and the Company remains on track to file a Premarket Approval Application later this year.  Gen-Probe is seeking U.S. regulatory approval to use the assay on its semi-automated instrument system to test urine samples from men who previously have had a negative prostate biopsy.  

For more information about the PROGENSA PCA3 assay, visit www.PCA3.org.

About Gen-Probe

Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility.  Gen-Probe has approximately 27 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,300 people. For more information, go to www.gen-probe.com.

Caution Regarding Forward-Looking Statements

Any statements in this press release about Gen-Probe's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements.  These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would.  For example, statements concerning new products, potential regulatory approvals, customer adoption, and results of future clinical studies are all forward-looking statements.  Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied.  Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to: (i) the risk that results from the U.S. clinical trial of our PCA3 test will not be favorable; (ii) the risk that our PCA3 test will not be approved by FDA for marketing in the U.S. in the timeframes we expect, if at all; (iii) the possibility that the market for the sale of our PCA3 product may not develop as expected; (iv) the risk that we may not be able to compete effectively with other tests for prostate cancer; (v) the risk that we may not be able to maintain our current exclusive license concerning PCA3; and (vi) the risk that our third party distributors may not distribute our products effectively.  The foregoing describes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements.  For additional information about risks and uncertainties Gen-Probe faces and a discussion of the Company's financial statements and footnotes, see documents filed with the SEC, including the most recent annual report on Form 10-K and all subsequent periodic reports.  We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.

SOURCE Gen-Probe Incorporated