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Gen-Probe, San Diego, and DiagnoCure, Quebec City, have signed a license and collaboration agreement under which they will develop, and Gen-Probe will market, an innovative urine test to detect a new, highly specific genetic marker for prostate cancer.

The diagnostic test will detect a recently described gene called PCA3 DD3 that has been shown by studies to date to be over-expressed only in malignant prostate tissue. The test may offer advantages over prostate specific antigen (PSA) testing, the current standard for initial prostate cancer screening in conjunction with a digital rectal exam.

Under the terms of the agreement, Gen-Probe will pay DiagnoCure an upfront US $3 million fee, and future fees and contract development payments of up to US $7.5 million over the next three years. Gen-Probe will receive exclusive worldwide rights to diagnostic products resulting from the agreement, and will pay DiagnoCure royalties of 8% on cumulative net product sales of up to $50 million, and royalties of 16% on cumulative net sales above $50 million.

"The completion of this license agreement represents a major milestone in our planned and communicated strategy," said Pierre Dsy, president and CEO of DiagnoCure. "We expect this test to detect the PCA3DD3 gene in urine to be the first gene-based, adjunctive screen for this devastating disease. Gen-Probe is the ideal partner to bring this important new test to the market. Their leadership in nucleic acid testing (NAT), their proprietary APTIMA(r) technologies, and their strong desire to become a leader in gene-based testing in oncology are the fundamentals that will realize and optimize all the potential of this marker.''

"Broadening our core NAT technologies into cancer testing is an important part of Gen-Probe's growth strategy, and this agreement with DiagnoCure is an excellent fit with both our proprietary technology and our business goals," said Henry L. Nordhoff, chairman, president and CEO of Gen-Probe. "We expect this collaboration to accelerate our entry into cancer screening, as well as provide another clinically important addition to the menu of tests that will be run on our innovative, fully automated TIGRIST instrumentation system."

The PCA3DD3 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 in Baltimore. PCA3DD3 is the most prostate-cancer specific gene described to date. DiagnoCure has developed a first-generation version of a PCA3 DD3 test that is offered in the United States as an analyte specific reagent.

DiagnoCure has evaluated its first-generation test (called uPM3(tm)) in a clinical study of 443 men. In the study, the test had a positive predictive value of 75% (75% of patients with positive test results were found to have cancer by biopsy), and a negative predictive value of 84% (84% of patients with negative test results were found to be cancer-free by biopsy) in men having a PSA level of 2.5 ng/ml or higher. These results, which are significantly more accurate than those achievable with PSA screening, have been presented at several international urology meetings and were recently submitted for publication.

In addition, a recent article by Dr. Schalken's group in the journal European Urology (44, 2003, 8-16) reported on a European clinical trial in 108 men with PSA levels of 3.0 ng/ml or higher. The study demonstrated that if a PCA3 DD3 test were negative for prostate cancer, there would be a 90% chance that a subsequent biopsy would be negative.

In recent years, the scientific community increasingly has questioned the accuracy of PSA screening, which was introduced 17 years ago and has significant limitations.

First, because the antigen is specific for prostate tissue, not prostate cancer, an elevated PSA does not always indicate prostate cancer. Only 25% of patients found to be positive (>4.0 ng/ml) by PSA screening will be confirmed by a biopsy to have cancer. As a result, urologists must decide whether to conduct another biopsy or additional PSA tests in pursuit of an adequate diagnosis, or to delay follow-up, potentially allowing an undiagnosed tumor to grow unchecked. Furthermore, many prostate cancer experts now advocate an even lower PSA threshold for biopsy in an effort to detect more cancers. This lower threshold, however, would significantly increase the number of expensive and uncomfortable biopsies, many of which would be negative.

Second, because not all prostate cancers release high levels of antigen into the blood, routine PSA screening often fails to detect clinically significant cancers. These "false negative" results can lead to delayed detection, which reduces the chance that treatment will be effective once the diagnosis has been made.

According to the American Cancer Society, prostate cancer is the most prevalent cancer in men, with more than 220,000 new cases and nearly 30,000 deaths in the United States in 2003. It is estimated that more than 40 million PSA tests are performed worldwide each year, and the market is expected to grow significantly in the future as the population ages.

About Gen-Probe

Gen-Probe Incorporated, founded in 1983, is a global leader in the development, manufacture and marketing of rapid, accurate and cost- effective nucleic acid testing products used for the clinical diagnosis of human diseases and for screening donated human blood. Using its patented NAT technology, Gen-Probe has received FDA approvals or clearances for more than 60 products that detect a wide variety of infectious microorganisms, including those causing sexually transmitted diseases, tuberculosis, strep throat, pneumonia and fungal infections. Additionally, the company developed and manufactures the only FDA-approved blood screening assay for the simultaneous detection of HIV-1 and HCV, which is marketed by Chiron Corporation. Gen-Probe and Bayer Corporation have formed a collaboration to develop, manufacture and market nucleic acid diagnostic tests for certain viral organisms, and under the agreement Bayer has the right to distribute these tests, including the recently approved VERSANT HCV Qualitative Assay. Gen-Probe has 20 years of nucleic acid detection research and product development experience, and its products are used daily in clinical laboratories and blood collection centers throughout the world. Gen-Probe is headquartered in San Diego, California and has approximately 700 employees.

For more information, visit or call 858/410-8673.

About DiagnoCure

DiagnoCure specializes in the development, production and commercialization of diagnostic tests for the detection of cancer. DiagnoCure's mission is to be a leading developer of highly accurate immunoassay and molecular tests enabling the early detection of cancer. Their first product, ImmunoCyt, is an important tool for the diagnosis and monitoring of patients with bladder cancer. In addition to their work on the PCA3 technology in early-stage prostate cancer diagnosis, DiagnoCure is actively pursuing the development of a prototype test for lung cancer detection. The company is headquartered in Quebec City, Canada.

For more information, visit or call 418/527-6100.
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Publication:Worldwide Biotech
Date:Jan 1, 2004

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