DGAP-News: WILEX's subsidiary WILEX Inc. receives ISO certification
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Miscellaneous
WILEX's subsidiary WILEX Inc. receives ISO certification
03.08.2011 / 08:34
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PRESS RELEASE
WILEX's subsidiary WILEX Inc. receives ISO certification
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
Contact
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
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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03.08.2011 Dissemination of a Corporate News, transmitted by DGAP - a
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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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134216 03.08.2011
Datum: 03.08.2011 - 08:34 Uhr
Sprache: Deutsch
News-ID 41125
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Kategorie:
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