WILEX?s subsidiary WILEX Inc. receives ISO certification
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Munich, Germany, 3 August 2011. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today announced that the wholly owned US subsidiary WILEX Inc., Cambridge, MA, USA, received ISO certifications 9001:2008 and 13485:2003 for its production facility. WILEX Inc. acquired the assets of Oncogene Science, a former commercial business entity of Siemens Healthcare Diagnostics Inc., in November 2010. The ISO certifications are a prerequisite for WILEX Inc. to continue the former Oncogene Science business such as the manufacture and the distribution of their biomarker tests.
WILEX Inc. focuses on the manufacturing, marketing and sales of biomarker assays and on developing companion diagnostics for targeted oncology therapies. The well-respected Oncogene Science biomarker tests for measuring oncogenes, growth factor receptors (HER-2, EGFr), proteases and protease inhibitors (uPA, PAI-1, TIMP-1), as well as markers of hypoxia (CA IX), continue to provide clinical researchers the tools they need for advancing oncology research as well as to assist in drug discovery and development. Along with the selection of research use only kits, WILEX Inc. provides in vitro diagnostics (IVD), such as the FDA cleared Serum HER-2/neu ELISA test.
ISO 9001 confirms the appropriate framework is in place to develop and manufacture in vitro diagnostics that meet customer requirements. ISO 13485 is specific for medical devices, and ensures the ability to meet many regulatory requirements, with an emphasis on risk management to ensure the safe design, manufacture and distribution of medical devices. These two international standards ensure characteristics of products such as quality, safety, and reliability. Furthermore the ISO certifications facilitate the registration and licensing of the diagnostic tests to distribute them to customers worldwide.
Prof Dr Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, comments: “The ISO certification is an important step after acquiring the business activities of Oncogene Science. In the next months we expect to complete further regulatory work and provide customers worldwide with our diagnostics tests.”
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the company has a broad portfolio of near-to-market therapeutic and diagnostic products for the targeted treatment and specific detection of various types of cancer. The company’s therapeutic product candidates are based on antibodies and small molecules. Through its US subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of research use only and in vitro diagnostic tests under the brand Oncogene Science. These diagnostic tests could be developed as companion diagnostics in clinical trials and for therapy monitoring. Furthermore, the acquisition of Heidelberg Pharma AG is set to give WILEX access to an attractive and highly promising antibody drug conjugate technology platform and a pre-clinical service business. The business model of WILEX covers the entire value chain in the oncology market and comprises research, technology, development collaboration as well as sales and marketing. WILEX’s customers and partners include leading international pharmaceutical companies. Website: http://www.wilex.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
About WILEX Inc.
WILEX Inc. is a wholly owned US subsidiary of the WILEX group. Since November 2010 the company has been marketing diagnostic tests in oncology under the brand name Oncogene Science with the aim of supporting treatment regimens for cancer patients worldwide. WILEX Inc. currently offers seven biomarker tests for a variety of oncological targets or genes, including the HER-2/neu IVD ELISA. A differentiation is made between enzyme linked immunoassays (ELISA) and immunohistochemical (IHC) assays. More information on www.oncogene.com
Katja Arnold (CIRO)
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
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