DGAP-News: WILEX AG: WILEX Inc. lists Oncogene Science(R) CA IX IHC Kit as an In-Vitro-Diagnostic with the FDA
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Research Update
WILEX AG: WILEX Inc. lists Oncogene Science(R) CA IX IHC Kit as an
In-Vitro-Diagnostic with the FDA
07.12.2011 / 09:44
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PRESS RELEASE
WILEX Inc. lists Oncogene Science(R) 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(R) 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(R). 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.
Contact Press
WILEX AG
Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-Mail: investors(at)wilex.com
Contact Customer Service
WILEX Inc. | Oncogene Science
100 Acorn Park Drive
Cambridge, MA 02140, USA
Tel: +1-617-492-3900 x501
Fax: +1-617-492-3905
Email: oncogeneorders(at)wilex.com
This communication contains certain forward-looking statements relating to
the Company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will' 'should' 'future', 'potential' or similar expressions or by a
general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings or achievements
expressed or implied by such forward-looking statements. Given these
uncertainties, prospective investors and partners are cautioned not to
place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments.
End of Corporate News
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Language: English
Company: WILEX AG
Grillparzerstr. 10
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info(at)wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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