bioMérieux to Develop New Highly-Specific, Non-invasive Test for Prostate Cancer, Reducing Unnecessary Biopsies

Marcy l'Etoile, France - September 25, 2008. Prostate cancer is the most prevalent cancer in the United States and the 4th most common worldwide. The combination of a test for a new prostate cancer biomarker, Annexin 3, with the standard screening methods could potentially reduce the number of biopsies conducted by up to 75%, when compared with current screening methods alone.

A world leader in the field of in vitro diagnostics, bioMérieux has signed a license and development agreement with the German biotechnology company, ProteoSys, for Annexin 3, which will be used to develop a urine-based, confirmatory diagnostic test for prostate cancer. After a research phase, the new test should be developed on the VIDAS® platform, one of the most widely installed automated immunoassay instruments in the world.

“It was an obvious choice to partner with bioMérieux because of its strategic focus on oncology, the market leadership of its VIDAS platform and its extensive commercial network,” stated André Schrattenholz, Chief Scientific Officer of ProteoSys.

“We are very pleased to work with ProteoSys to bring such an innovative biomarker to urologists around the world,” declared Stéphane Bancel, Chief Executive Officer of bioMérieux. “This agreement is yet another building block in our high medical value test strategy.”

Annexin 3, also known as ANXA 3, was discovered by ProteoSys, a German biotechnology company based in Mainz, which specializes in the fields of cell biology and proteomics. Studies have shown that ANXA 3 quantification in urine is a novel, non-invasive test with high specificity for prostate cancer (1). Today, when the levels of PSA (Prostate Specific Antigen) are in the uninformative “grey zone”, a biopsy is used to provide definitive diagnosis. The ANXA 3 test would be used to provide better identification of patients with a high probability of prostate cancer, thereby reducing the number of unnecessary biopsies.

While complications are relatively rare, biopsies cause patient anxiety and discomfort as well as extra cost to the healthcare system. In the United States, only an estimated 15% of patients who undergo a biopsy actually are diagnosed with prostate cancer, while each biopsy costs over $1,000.

The first phase of research is beginning at bioMérieux, which will be followed by the development of a diagnostic test for the VIDAS platform. While the confirmatory diagnostic application on VIDAS will be the initial focus, bioMérieux is also considering the development of treatment decision and prognostic applications for ANXA 3, as described in a leading publication (2). The financial details of the deal are not disclosed.

The ANXA 3 test will be complementary to the tPSA and FPSA tests available on VIDAS. bioMérieux is developing a substantial panel of high medical value assays for the VIDAS system, which already include VIDAS B·R·A·H·M·S PCT for sepsis, VIDAS Clostridium difficile A & B, for healthcare-associated infections, and VIDAS D-Dimer Exclusion™, VIDAS Troponin I, VIDAS CK-MB and VIDAS NT-proBNP for cardiovascular emergencies.

About ProteoSys

ProteoSys AG in Mainz (www.proteosys.com) is a research venture with a focus on systems biology, employing proprietary technology platforms for integrating quantitative proteomic and cellular information. The key technology Proteotope delivers precise and statistically significant information about protein biomarkers as surrogates for modes of action in therapeutic approaches, diagnostics and in the analysis of toxicity. ProteoSys has successful projects on prostate and breast cancer, neurodegenerative diseases, and test systems for embryo toxicity. In the more than 8 years of its existence, ProteoSys has built up a portfolio of intellectual property, which led to license agreements with partners in diagnostic and pharmaceutical industries. Next to its own development projects, ProteoSys also works in cooperation with the life science industry and in a variety of national and international research projects funded by the European Union (FP6 & FP7) and the German ministry of research and technology (overview of projects and peer-reviewed publications at http://www.proteosys.com/).