PROGENSA(R) PCA3 Assay Can Help Guide Repeat Prostate Biopsy Decisions, Data Presented at Leading Medical Meeting Confirm

SAN DIEGO, March 8 /PRNewswire-FirstCall/ -- Gen-Probe's (Nasdaq: GPRO) PROGENSA® PCA3 assay can help determine whether men suspected of having prostate cancer should undergo a repeat biopsy, according to data from the two largest studies to date of the molecular urine test.  The studies were presented last week at the American Society of Clinical Oncology's (ASCO) Genitourinary (GU) Cancers Symposium in San Francisco.

"These two studies, which involved more than 2,400 men, are the most significant conducted thus far of our PROGENSA PCA3 molecular urine test, and confirm the assay's ability to predict the outcome of a repeat prostate biopsy, thereby helping physicians provide more appropriate, personalized patient care," said Eric Lai, PhD, Gen-Probe's senior vice president of research and development.  

In the studies presented at the ASCO GU meeting, PCA3 was used to test urine samples from men enrolled in the REDUCE trial of GlaxoSmithKline's drug dutasteride.  PCA3 testing was done on urine samples from 1,140 men in the placebo arm of the REDUCE trial, and from 1,308 men in the dutasteride arm.  All men underwent prostate biopsies two and four years after enrollment.

The first PCA3 study presented at the meeting originated from the placebo arm of the REDUCE trial.  This study, which was highlighted in ASCO's official press program, showed that PCA3 scores were significantly correlated with a positive prostate biopsy result (P<0.0001), and that men who had higher PCA3 scores were more likely to have prostate cancer.  Specifically, cancer was diagnosed in only 6% of men with very low PCA3 scores, but in 57% of men with very high PCA3 scores.

PCA3 scores also correlated with cancer aggressiveness: median PCA3 scores were higher in men with high-grade cancers than in those with low-grade cancers (P=0.0017).  Finally, the PCA3 test also predicted the likelihood of a prostate cancer diagnosis on a future biopsy.  Specifically, men with elevated PCA3 scores and negative biopsies at the two-year mark were twice as likely as men with lower PCA3 scores and negative biopsies to have cancer detected at the four-year mark (P=0.0002).

The second PCA3 study presented at the ASCO GU meeting originated from the dutasteride arm of the REDUCE trial.  This study, which was selected for oral presentation at the meeting, showed that PCA3 also can be used to predict prostate biopsy outcomes in men taking dutasteride.  In contrast to serum PSA testing, median PCA3 scores were equivalent in the placebo and dutasteride groups, and PCA3 sensitivity and specificity were also similar between the two groups.

The second study also confirmed earlier research that showed PCA3 outperforms serum PSA testing for prostate cancer detection, and improves diagnostic accuracy when combined with serum PSA testing and other clinical information.

About Prostate Cancer and PCA3

According to the European Prostate Cancer Coalition, prostate cancer is one of the most common men's cancers in Europe.  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.

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 assay for use on its semi-automated instrument system.  The Company remains on track to file a Premarket Approval Application later this year.

Data from approximately 30 peer-reviewed publications suggest that the PROGENSA PCA3 assay, when used with other patient information, may help address some of the well-known challenges urologists face when identifying prostate cancer, such as minimizing unnecessary biopsies.

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 US 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 US 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

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