QIAGEN Eliminates Key Bottleneck in Epigenetic Research
First Product to Streamline the Preanalytical Process for DNA Methylation Analysis in Clinical and Molecular Diagnostics Research Launched
Venlo, The Netherlands - April 25, 2006 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA), a leading provider of molecular diagnostics products and the world's premier supplier of solutions for preanalytical sample preparation, today announced the launch of QIAGEN's EpiTect Bisulfite Kit for standardized sample processing for DNA methylation analysis. This preanalytical solution also incorporates certain technologies from Epigenomics ( Frankfurt , Prime Standard: ECX) for DNA methylation. The solution presents a new dimension of capabilities for epigenetics in molecular diagnostics, pharmacogenetics and research.
Epigenetics is one of the fastest growing areas of molecular biology research and holds the promise for breakthroughs in research and a wide variety of next generation molecular diagnostic tests. One of the most important epigenetic parameters is DNA-methylation, a phenomenon occurring on DNA, known to consist of four bases. In humans, only one of them, cytosine, exists in a "normal" and in a methylated version (i.e. with a methyl group attached). The consequences of methylation lie in the regulation of gene expression: methylated cytosines in a specific region of a gene lead to inactivation, thus acting as an "on" and "off" switch for genes.
QIAGEN's new EpiTect Bisulfite Kit, developed in collaboration with Epigenomics, significantly facilitates the complex and time consuming step of DNA bisulfite treatment in DNA methylation analysis. The busulfite treatment (i.e. the conversion of a methylated Cytosin into a labeling Uracil) allows methylated DNA to be distinguished from unmethylated DNA by standard molecular biology techniques including DNA sequencing and polymerase chain reactions (PCR).
The bisulfite treatment of DNA is an integrated, chemical modification of DNA following collection, stabilization and purification of the sample. The streamlined procedure combines two key technologies, an optimized DNA cleanup procedure, based a unique DNA cleanup and purification technology from QIAGEN and a solution including a proprietary technology from Epigenomics, which prevents DNA from excessive degradation during the chemical treatment and ensures best possible yields in the chemical modification step.
Prior to the launch of QIAGEN's EpiTect Bisulfite Kit the bisulfite conversion step was mostly achieved through homebrew solutions which demonstrated significant loss or damage of sample material and low reliability. In addition, the homebrew protocols could not be automated and often required 20 hours or more of processing per sample.
The newly launched EpiTect Bisulfite Kit eliminates the bottleneck in DNA methylation analysis by completing QIAGEN's portfolio for DNA sample processing with an easy-to-use, standardized, rapid and robust bisulfite treatment procedure. It creates a new dimension of possibilities for users in this rapidly growing field and extending QIAGEN's market and technology leadership in preanalytical sample processing into the fields of epigenetics.
"QIAGEN's EpiTect Bisulfite Kit is the first standardized solution for efficient and time-saving conversion of DNA for methylation analysis. Together with the EpiTect Bisulfite Kit QIAGEN provides a complete portfolio of standardized solutions for epigenetics research, from DNA sample collection, stabilization and purification, to bisulfite conversion and methylation-specific PCR analysis or sequencing. Our products enable researchers in this field to achieve faster and more reliable results, " commented Dr. Dirk Löffert, QIAGENs' Director R&D of Nucleic Acid Modification & Amplification Technologies. "With the launch of our EpiTect Bisulfite Kit, QIAGEN once again sets a gold-standard for preanalytical sample processing - this time in the early days of DNA methylation analysis. We are proud to provide this exciting new solution to this field and thereby help fuel epigenetics research in research, in-vitro diagnostics and pharmacogenomics."
"In DNA methylation research, bisulfite treatment has always been considered the major bottleneck, preventing many groups from contributing to the emerging field of epigenetics and limiting throughput and reproducibility of their experiments. Epigenomics is glad that the technical solution we developed to solve this problem now has led to a product with outstanding performance that will serve the scientific community", added Dr. Kurt Berlin, Chief Scientific Officer of Epigenomics. "For us, QIAGEN is the most competent partner in preanalytics to set the standard for methylation based in vitro diagnostic (IVD) tests in general and for our diagnostic product pipeline in particular. The EpiTect Bisulfite Kit launched today is a significant milestone towards this goal."
QIAGEN obtained a world-wide exclusive license from Epigenomics in May 2005 to develop, market and sell preanalytical solution containing bisulfite treatment technology for research purposes as well as a license for diagnostics applications for use with Epigenomics' assay technologies. QIAGEN and Epigenomics plan to work on a preanalytical solution containing bisulfite technology for the molecular diagnostic market, which is intended to be marketed and sold by Epigenomics through an OEM (Original Equipement Manufacturer) agreement with QIAGEN.
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, is detected. Epigenomics has developed an industrial process that allows to detect and to analyse these methylation patterns.
QIAGEN N.V., a Netherlands holding company with subsidiaries in Germany, the United States, Japan, the United Kingdom, Switzerland, France, Italy, Australia, Norway, Austria, Canada, China, Malaysia, Sweden, and the Netherlands believes it is the world's leading provider of innovative enabling technologies and products for molecular diagnostics solutions and preanalytical sample preparation for the separation, purification and handling of nucleic acids and proteins. QIAGEN has developed a comprehensive portfolio of more than 320 proprietary, consumable products for nucleic acid and protein separation, purification and handling, nucleic acid amplification, as well as automated instrumentation, synthetic nucleic acid products and related services. QIAGEN's products are sold in more than 42 countries throughout the world to academic research markets and to leading pharmaceutical and biotechnology companies. In addition, QIAGEN is positioning its products for sale into developing commercial markets, including applied testing markets, clinical research, nucleic acid-based molecular diagnostics, and genetic vaccination and gene therapy. QIAGEN employs more than 1,700 people worldwide. Further information on QIAGEN can be found at www.qiagen.com.
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics' tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics collaborates with Roche Diagnostics on the development of several diagnostic products in cancer. The company has its headquarters in Berlin , Germany , and a wholly owned subsidiary in Seattle , USA . For more information, please visit our website at www.epigenomics.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, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, 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 ), 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, the integration of acquisitions of technologies and businesses, and the timing of product introductions by our commercial partners. 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).
Dr. Solveigh Mähler