Berlin, Germany, and Seattle, WA, USA, June 30, 2009 - Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular diagnostics company focusing on the development and commercialization of in vitro diagnostic products for cancer, has received ISO 13485 certification for its quality management system. The certification was granted for Epigenomics’ headquarters in Berlin, Germany, and its subsidiary Epigenomics, Inc. in Seattle, WA, USA, for the design, development, manufacturing, and distribution of in vitro diagnostic (IVD) products. The certificate demonstrates the successful implementation and use of a quality management system that conforms to the international quality management standard for medical devices that also includes IVD products such as Epigenomics’ tests for colorectal, lung, and prostate cancer.
“We have implemented a quality management system that is a solid foundation for future regulatory approval of our products on a global basis,” said Geert Nygaard, CEO of Epigenomics. “Over the last couple of years we have transformed Epigenomics into a fully integrated molecular diagnostics company. The ISO certification reflects our strong commitment to quality and is an important corporate milestone in the commercial strategy for our cancer tests.”
ISO 13485 is an internationally recognized quality management standard developed for medical devices by the International Organization for Standardization (ISO), a world-wide federation of national standards bodies. ISO 13485 specifies requirements for a quality management system, which demonstrates the organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The implementation of an ISO 13485 compliant quality management system demonstrates Epigenomics’ commitment to develop safe and effective diagnostic products.
About Epigenomics
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.
Epigenomics’ product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in urine, blood and bronchial lavage specimens. Epigenomics’ biomarker mSEPT9 for the early detection of colorectal cancer in a simple blood sample has demonstrated continuously highest performance in multiple clinical studies with in total more than 3,000 individuals tested. A large prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a screening population is currently under way (www.presept.net).
For development and global commercialization of in vitro diagnostic test products, Epigenomics pursues a non-exclusive partnering strategy. Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation and Quest Diagnostics Incorporated, for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products.
Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com.
Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.
