New Molecular Test To Improve Prostate Cancer Diagnosis

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Cancer / Oncology
Article Date: 22 Sep 2007 - 14:00 PST

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PROGENSA™ PCA3, the world's first molecular urine test to aid in the diagnosis of prostate cancer, was launched in London. Scientific data suggest that the test could be a vital clinical tool. 1-4 PROGENSA™ PCA3 is manufactured and marketed by Gen-Probe Incorporated.

Dr. Chris Hiley, Head of Policy and Research Management, at The Prostate Cancer Charity said: "Prostate cancer can be difficult to diagnose. Current diagnostic tools for prostate cancer, such as the serum-PSA test, have their drawbacks so PROGENSA TM PCA3 is a welcome addition."

PROGENSA™ PCA3 is the first test to use the presence of PCA3 (a genetic marker for prostate cancer) to predict for prostate cancer, and can be used in conjunction with current tests to confirm diagnosis. 1-4

Dr Chris Hiley continues: "The test has the potential to make a big difference to some men's lives by helping doctors decide whether or not to proceed with more biopsies - which can be painful and can have unwanted side effects. If the test indicates it is unlikely that the man has prostate cancer this reassures both the man and his doctor and these repeat tests can be avoided."

PROGENSA™ PCA3 is expected to address some of the limitations of existing diagnostic tools. For example, PSA (Prostate Specific Antigen) is commonly elevated for reasons not related to cancer. 5;6 As a result, PSA testing produces many 'false positive' results, which can lead to uncomfortable, expensive biopsies that ultimately prove unnecessary. In contrast, the genetic marker PCA3 is elevated only in cancerous prostate tissue, making it a more specific indicator of cancer than PSA, potentially reducing the number of unnecessary biopsies.

Professor Roger Kirby of the London Prostate Cancer Treatment Centre said: "The biggest worry in prostate cancer diagnosis is the uncertainty that surrounds a raised PSA level. PROGENSA™ PCA3 could help improve the likelihood of a prompt diagnosis. Any test that reduces the risk of undergoing an unnecessary biopsy is good news for patients."

"The launch of PROGENSA™ PCA3 in Europeshows Gen-Probe's commitment to the development of new, more accurate diagnostic tools to detect life-threatening disease, like prostate cancer," says Mr Henry Nordhoff, President, CEO and Chairman of the Board, Gen-Probe. "Gen-Probe is fully committed to developing tools to detect life-threatening conditions. We believe that molecular testing is the future of accurate prostate cancer diagnosis and hope that the PROGENSA™ PCA3 test will be widely used. "

- The prostate is a walnut-shaped gland that sits beneath the bladder and in front of the rectum. It is part of the male reproductive system.

- Prostate cancer is the most common cancer in men in the UK- it accounts for nearly a quarter (24%) of all new male cancer diagnoses. In 2004, there were 34,986 new cases of prostate cancer diagnosed in the UK. 7

- Prostate cancer accounts for around 13% of male deaths from cancer in the UKand is the second most common cause of cancer death in men, after lung cancer. In 2005 there were 10,000 deaths in the UKfrom prostate cancer - one man every hour dies from this disease. 8

- The strongest known risk factor is age, with very low risk in men under 50 and rising with increasing age thereafter.

- African Caribbean men are three times more likely to be diagnosed with prostate cancer than their white counterparts.

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 Diegoand employs approximately 1,000 people. For more information, go to www.gen-probe.com.

Forward-Looking Statements

Any statements in this press release about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are 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. For information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we have filed with the SEC, including the Form 10-Q for the quarter ended March 31, 2007, and all subsequent periodic filings made with the SEC. 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 press release or to reflect the occurrence of unanticipated events.

(1) Groskopf J, Aubin SM, DerasILet al.APTIMA PCA3 molecular urine test: development of a method to aid in the diagnosis of prostate cancer. Clin Chem 2006; 52(6):1089-1095.

(2) Kirby R. PCA3 improves diagnosis of prostate cancer KIRBY2007. Practitioner 2007; 251(1690):18, 21, 23.

(3) Marks LS, Fradet Y, DerasILet al.PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy. Urology 2007; 69(3):532-535.

(4) Schalken J. Interview with Jack Schalken. PCA3 and its use as a diagnostic test in prostate cancer. Interview by Christine McKillop. Eur Urol 2006; 50(1):153-154.

(5) The Prostate Cancer Charity. The PSA test. HYPERLINK "Click here . 2007.

(6) The Prostate Cancer Charity. PSA background. Click here. 2007.

(7) Office for National Statistics. Cancer Statistics registrations: Registrations of cancer diagnosed in 2003, England. 2007.

(8) Office for National Statistics. Review of the Registrar General on deaths by cause, sex and age, in Englandand Wales, 2005. Series DH2 no.32. 2007.

http://www.gen-probe.com