Expanded EpiTect portfolio targets growing demand for standardized sample and assay technologies to investigate processes regulating gene function
Venlo, The Netherlands – June 18, 2008 – QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced a significant expansion of its EpiTect product portfolio for epigenetics, one of the most dynamic areas in life sciences. With the five new products, QIAGEN now offers standardized solutions covering all steps of epigenetic research processes in molecular diagnostics, pharma and life sciences. By removing existing bottlenecks in epigenetic research, the new products are expected to advance progress in the development of new diagnostics and therapeutics for cancer and other diseases.
Epigenetics focuses on the study of various phenomena which are linked to the genome but do not result from genetic variability. One of the major mechanisms which has been identified to regulate gene expression is a chemical modification of the DNA called DNA methylation, acting like an “on” and “off” switch for genes. As DNA methylation is believed to play a major role in many diseases, in particular cancers, epigenetic research holds great promise for the development of novel biomarkers in diagnostics and for therapeutics. Scientific progress has been hindered by a lack of standardized methods and incompatibilities between technologies employed. QIAGEN is now removing these barriers with the expansion of its EpiTect product line, providing its customers in molecular diagnostics, pharma and life sciences with complete pre-analytical and analytical workflow solutions which guarantee reproducible results even from scarce tissue samples and highest quality of downstream applications.
Epigenetic research has recently gained significant momentum leading to many stunning discoveries. Discoveries show that various cell types have unique patterns of DNA methylation, thus providing an explanation for the transformation of stem cells to various tissue types in the human body. In addition, research demonstrates that methylation patterns can change over time as a reaction to environmental conditions and are also hereditary. That way, the behaviour of an individual – e.g. his nutrition uptake – can have an influence on future generations.
The overall market for epigenetic applications is currently estimated to grow at an annual compound growth rate of 60 percent and to exceed US$ 4 Billion by 2012. Thereby, research primarily aims to deepen our understanding of the highly sophisticated epigenetic regulation mechanism and to develop new therapeutics targeting and diagnostics incorporating DNA methylation patterns as highly sensitive and specific biomarkers.
“Epigenetics is an extremely dynamic area of research and an important market for QIAGEN,” said Gerald Schock, Global Product Manager WGA Epigenetics at QIAGEN. “Our expanded portfolio brings a new level of efficiency, convenience and reliability to epigenetic research and will help to further advance and disseminate epigenetic applications by removing key bottlenecks previously hindering the corresponding research work.”
At an early stage, QIAGEN recognized the growing market demand for specific, standardized sample and assay technologies for epigenetic research and launched its first product in 2006, establishing a new standard for sample processing for DNA methylation analysis. The expanded product offering includes a novel technology representatively amplifying specifically treated DNA needed for the methylation analysis, allowing researchers to perform multiple tests from limited sample material. Moreover, these products include a real-time PCR based test-kit for the quantitative analysis of methylated DNA, assays for differentiation of methylated DNA in genes related to cancer and a novel PCR based technology which significantly improves accuracy of qualitative analysis of methylated DNA. Finally, the portfolio includes control DNAs used to verify methylation analysis, thus increasing standardization in assay setups.
About DNA methylation
The ability to detect and quantify DNA methylation efficiently and accurately is an essential tool for scientists to study the role of epigenetic changes in cancer and other serious diseases, as well as many other clinical applications. Methylation is a natural process that occurs when cytosine, one of the DNA’s four bases, will be modified with a methyl group. The presence of methylation is responsible for controlling the activity of genes by turning them off, like a switch, when not needed. By measuring the differences in the methylation patterns between healthy and diseased tissue, a change in gene activity as an early prognostic biomarker that could trigger diseases, such as cancer, can be detected.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make isolated biomolecules visible for study. QIAGEN has developed and markets more than 500 consumable products as well as automated solutions. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN’s assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 2,700 people in over 30 locations worldwide. Further information about QIAGEN can be found at www.qiagen.com.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, markets, strategy or operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, women’s health/HPV testing markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, changing relationships with customers, suppliers and strategic partners, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN’s, products (including fluctuations due to the level and timing of customers’ funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors’ products, market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).