WILEX Inc. lists Oncogene Science® CA IX IHC Kit as an In-Vitro-Diagnostic with the FDA
Cambridge, MA, USA, and Munich, Germany, 7 December 2011. WILEX Inc., a wholly owned US subsidiary of WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange), today announced the listing of the CA IX IHC kit as a Class I 510(k)-exempt medical device with the FDA. This immunohistochemistry (IHC) kit is used to identify the antigen Carbonic Anhydrase IX (CA IX) in tissues or cytologic specimens. In addition to the Oncogene Science® CA IX ELISA, a research use only enzyme-linked immunoassay used for the quantitative detection of the circulating form of the CA IX protein in human serum and plasma, the IHC kit complements WILEX Inc.’s offer in the field of CA IX.
WILEX Inc. focuses on the manufacturing, marketing and sales of biomarker assays and on developing companion diagnostics for targeted oncology therapies. The protein CA IX is overexpressed in many types of cancer and its expression is strongly induced by hypoxia. In a variety of human cancers, tumor hypoxia is associated with an increased incidence of metastases. CA IX measurement has been reported as a potential biomarker for clear cell renal cell carcinoma.
The CA IX IHC kit is an in-vitro diagnostic device (IVD) consisting of a monoclonal antibody specific for CA IX along with HRP-labeled streptavidin-biotin immunohistochemical staining technology to detect presence of CA IX in formalin-fixed, paraffin embedded tissue sections. Positive and negative controls included assure accurate detection of CA IX in tissues. The CA IX IHC kit aids in the classification of normal and abnormal cells or tissues and serves as an adjunctive test to support conventional histopathology diagnosis.
About WILEX Inc.
WILEX Inc. is a wholly owned US subsidiary of WILEX AG and manufactures, markets and sells diagnostic tests in oncology under the brand name Oncogene Science®. The product portfolio includes enzyme linked immunosorbent assays (ELISA) and immunohistochemical (IHC) assays. With the aim of supporting treatment regimens for cancer patients worldwide WILEX Inc. offers 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). In addition to the new CA IX IHC test WILEX Inc. provides the only FDA-cleared IVD ELISA that quantifies the serum HER-2/neu level for the management and monitoring of patient care for women with metastatic breast cancer. More information is available on www.oncogene.com and www.wilex.com.
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, USA, 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. The wholly owned subsidiary Heidelberg Pharma GmbH, Ladenburg, Germany, gives 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’ customers and partners include leading international pharmaceutical companies.
Website: www.wilex.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6.
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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