SAN DIEGO and QUEBEC CITY, Canada, March 29 /PRNewswire-FirstCall/ -- Gen-Probe's research test for the highly specific prostate cancer gene PCA3 in urine predicted the results of repeat biopsies more accurately than traditional prostate specific antigen (PSA) testing, according to a study of 233 men published in the March issue of the peer-reviewed journal UROLOGY(R) (69: 532-535, 2007).
"Men with elevated serum prostate-specific antigen (PSA) levels and negative prostate biopsy findings present a dilemma because of the lack of an accurate diagnostic test," said lead author Leonard S. Marks, MD, clinical associate professor of urology at UCLA and medical director of the Urological Sciences Research Foundation. "The results from this research study indicate that the PCA3 assay may be a new tool to assist clinicians in the treatment of these 'PSA dilemma' patients."
The study included men with serum PSA levels of at least 2.5 ng/mL from three North American hospitals. All the men previously had a negative biopsy, and were scheduled for a follow-up biopsy. The median age of the men was 64, and their median serum PSA level was 6.1 ng/mL. In the study, the researchers collected urine from the men after a digital rectal examination. Approximately 97% of the samples were "informative," meaning they contained adequate genetic material for analysis. Repeat prostate biopsies revealed prostate cancer in about 27% of these men.
The researchers found that the risk of a positive repeat biopsy correlated with the PCA3 score. For example, among the 26 men in the study who had a PCA3 score of less than 5, only 12% had a positive repeat biopsy. In contrast, among the 18 men with a PCA3 score greater than 100, 50% had a positive repeat biopsy. For all the men in the study, the PCA3 research assay yielded an odds ratio of 3.6, meaning that men with an elevated PCA3 score were 3.6 times more likely to have a positive repeat biopsy than men with a normal PCA3 score.
In addition, the researchers used a statistical method called receiver operating characteristic (ROC) curve analysis to assess the ability of the PCA3 research assay to predict the result of the follow-up prostate biopsy. For the PCA3 score, the area under the ROC curve was 0.68. In comparison, the serum PSA assay yielded an area under the curve of 0.52, "indicating little better than a 'coin toss' probability of predicting the presence of prostate cancer," according to the authors. In the study, the PCA3 assay had a sensitivity of 58%, and a specificity of 72%.
"About 1 million US men undergo a prostate biopsy annually to detect prostate cancer in only one-fourth of them," Dr. Marks said. "Furthermore, men with negative biopsy findings but elevated PSA levels still have the possibility of having prostate cancer. Many will undergo additional biopsies. The dollar cost, risk of morbidity, and emotional turmoil of repeat prostate biopsies are considerable, and a more accurate prostate cancer test would be an important clinical advance for this vexing problem. In this research study, the urinary PCA3 score was superior to serum PSA for predicting the outcome of repeat biopsies. The high specificity and informative rate suggest that the PCA3 research assay could have an important role in prostate cancer diagnosis."
Gen-Probe's PCA3 research test detects the overexpression of PCA3 mRNA in urine. Previous studies have shown that PCA3 is overexpressed, relative to benign cells, by 60- to 100-fold in more than 90% of prostate tumors, indicating that the gene may be a useful biomarker for prostate cancer. In contrast, serum PSA may be elevated due to a number of benign conditions, resulting in "false positive" results and unnecessary biopsies. In fact, as many as three-quarters of men suspected to have cancer based on serum PSA testing actually have non-cancerous conditions such as benign prostatic hyperplasia (BPH).
Gen-Probe's PROGENSA(TM) PCA3 assay is CE-marked, allowing it to be marketed in the European Union. The research assay is not approved for marketing in the United States.
The PCA3 gene was discovered by Dr. Marion Bussemakers while working with Dr. Jack Schalken at the University of Nijmegen in the Netherlands and in the laboratory of Dr. William Isaacs at Johns Hopkins University in Baltimore, Maryland. DiagnoCure Inc. is the exclusive worldwide licensee for all diagnostic and therapeutic applications of the gene. Gen-Probe acquired exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure in November of 2003.
About Gen-Probe
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 24 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 1,000 people. For more information, go to .
About DiagnoCure
DiagnoCure specializes in the development, production and commercialization of molecular diagnostics for the detection and management of cancer. Its first test, ImmunoCyt(TM) / uCyt+(TM) for bladder cancer, is distributed worldwide. In 2003, the Company entered into a strategic alliance with Gen-Probe for the development and commercialization of a second generation PCA3-based diagnostic test for prostate cancer. The Company plans to expand its product portfolio, namely in prostate, lung and other cancers. In addition to its own research, the Company intends to acquire or in-license promising cancer biomarkers from both academic and commercial institutions. Additional information can be found at .
Caution Regarding Forward-Looking Statements
Any statements in this press release about Gen-Probe's or DiagnoCure'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 R&D 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 by any forward-looking statement. 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 subsequent studies of our PCA3 assay may not reflect the results discussed here, (ii) the risk that new products, such as our PCA3 assay, will not be cleared for marketing in other markets in the timeframes we expect, if at all, (iii) the possibility that the market for the sale of our new products, such as our PCA3 test, may not develop as expected, (iv) we may not be able to compete effectively, (v) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, and (vi) we are dependent on third parties for the distribution of some of our products. 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.
Contacts:
Michael Watts
Sr. director, investor relations and corporate communications
858-410-8673
Thom Skinner
Chief Financial Officer
(418) 527-6100
e-mail: communications@diagnocure.com
Gen-Probe Incorporated
CONTACT: Michael Watts, Sr. director, investor relations and corporatecommunications of Gen-Probe Incorporated, +1-858-410-8673; or Thom Skinner,Chief Financial Officer of DiagnoCure, +1-418-527-6100,communications@diagnocure.com
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