SAN DIEGO, CA, Nov. 22, 2006 – Gen-Probe (NASDAQ: GPRO) announced today the European commercial launch of its PCA3 assay, a new prostate cancer-specific molecular diagnostic test, at the annual meeting of the British Association of Urological Surgeons Section of Oncology (BAUS). The PCA3 test has been CE marked, allowing it to be marketed in the European Union.
“The European launch of Gen-Probe's innovative PCA3 assay signifies our advancement into cancer diagnostics and continued expansion into international markets,” said Steve Kondor, Gen-Probe's vice president of sales and marketing. “Gen-Probe is committed to developing new, more accurate molecular diagnostic tools to detect life-threatening diseases like prostate cancer.”
Gen-Probe's PCA3 gene-based test detects the overexpression of PCA3 mRNA in urine. Studies have shown that, in greater than 95 percent of prostate cancer cases, PCA3 is 60 to 100-fold over-expressed in prostate cancer cells compared to normal cells, indicating that PCA3 may be a useful biomarker for prostate cancer.
Preliminary data show that the PCA3 assay is more specific to prostate cancer than the traditional serum prostate specific antigen (PSA) test, thus decreasing the likelihood of false positive results. PSA is produced by both cancerous and non-cancerous prostate cells. Non-cancerous conditions such as BPH can therefore cause elevated serum PSA levels that must be investigated, resulting in unnecessary medical procedures and patient anxiety.
“Only 25 to 30 percent of men who have a biopsy due to elevated PSA levels actually have prostate cancer, therefore the majority of elevated PSA tests are the result of non-cancerous conditions,” said Dr. Mark Emberton, BSc, FRCS, senior lecturer in oncological urology of the Institute of Urology and Nephrology at University College Hospital in London. “Unnecessary biopsies contribute to patient anxiety and are a burden on the healthcare system. We are optimistic that the Gen-Probe PCA3 test, used in combination with serum PSA, will further identify appropriate biopsy patients and that this will result in better detection and diagnosis of prostate cancer.”
The PCA3 molecular urine test is being offered through the following European laboratories: NovioGendix (Nijmegen, Netherlands), Centre of Applied Molecular Technologies Université catholique de Louvain (Brussels, Belgium), Medi-Lab (Manchester, UK), The Doctors Laboratory (London, UK), Labor Limbach (Heidelberg, Germany), and LCL (Paris, France). The test 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. (TSX: CUR) 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.
According to START Oncology in Europe, prostate cancer is the most frequent cancer among men in Northern and Western Europe. About 190,000 new cases occur each year, representing about 15 percent of all cancers in men. In Europe, annual incidence rates per 100,000 men range between 19 (in Eastern Europe) and 55 (in Western Europe). In most European countries, the incidence has increased more than any other cancer over the past two decades. In Europe, there are about 80,000 deaths a year from prostate cancer.
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 20 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 900 people. For more information, please visit 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 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 new products, such as our PCA3 assay, will not be cleared for marketing in other markets in the timeframes we expect, if at all, (ii) the possibility that the market for the sale of our new products, such as our PCA3 test, may not develop as expected, (iii) we may not be able to compete effectively, (iv) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, and (v) 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 we face and a discussion of our financial statements and footnotes, see documents we file with the SEC, including our 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.
Contact:
Michael Watts
Sr. director, investor relations and
corporate communications
858-410-8673
|