QIAGEN Launches Novel Product Enabling Non-Invasive Prenatal Diagnostics and Cancer Detection
May 25 2009

QIAGEN Launches Novel Product Enabling Non-Invasive Prenatal Diagnostics and Cancer Detection

 QIAamp kit sets new standard for the extraction of free circulating DNA and RNA fragments in human blood

Venlo, The Netherlands, May 25, 2009 --- QIAGEN today announced the launch of a novel product for extraction of free circulating fragments of tumor- and fetal-derived nucleic acids as well as viral nucleic acids in human blood. Scientists consider these DNA and RNA fragments to have great potential for the highly sensitive and non-invasive diagnosis of a wide range of diseases, including congenital disorders, malignancies such as colon and lung cancer, and infections. The new QIAamp Circulating Nucleic Acid Kit is expected to significantly facilitate the corresponding biomarker research and the introduction of novel molecular tests in prenatal diagnostics which can replace risky, invasive procedures such as amniocentesis.

Free circulating DNA and RNA fragments are found in body fluids such as plasma, serum and urine. Scientific research has demonstrated that plasma, in particular, carries a variety of nucleic acids from viruses and different tissues throughout the body, including developing fetuses and tumors. In cancer research, it has also been shown that the concentration of tumor DNA fragments is related to the extent of the disease. The analysis of such DNA and RNA fragments thus not only enables new, virtually non-invasive approaches to the early and highly sensitive detection of different malignancies such as colon or lung cancer, but can also help to monitor the progress of the disease and to assess patient outcomes. Likewise, fetal DNA and RNA fragments circulating in maternal blood can be used for the non-invasive molecular detection of congenital disorders in prenatal diagnostics, an area where QIAGEN also cooperates with Sequenom, Inc. which is a leader in this field.

QIAGEN's new QIAamp Circulating Nucleic Acid Kit for the first time enables the isolation and purification of all types and all sizes of nucleic acids from large-scale plasma and serum samples - and thereby enables unprecedented yields of the isolated molecules and the highest sensitivity of downstream applications. This significantly facilitates the molecular detection of viral infections, where extraction of even the scarcest traces of genetic material is a key requirement for reliable results. Moving forward, the company plans to extend the use of the product to urine samples and the isolation of free circulating miRNA molecules from plasma and serum, which can serve as highly specific biomarkers for cancer.

"Our new product brings major improvements to biomarker research for cancer and the development of novel, virtually non-invasive diagnostics based upon nucleic acid fragments circulating in body fluids", said Uwe Oelmueller, Senior Director R&D Diagnostic Sample Preparation and Stabilization at QIAGEN. "The clinical value of this method is well documented, but its widespread implementation and progress in further research have been hampered by the cumbersome and demanding methodology for handling such molecules. The new QIAamp kit removes this bottleneck and will bring significant value for researchers and clinicians."

The novel kit is currently available for research use only. The company plans to validate the product for in-vitro diagnostic applications in the United States and Europe.


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 such isolated biomolecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. 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 digene HPV Test, which is regarded as the "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 3,100 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.

Statements contained in this release that are not historical facts are forward-looking statements, including statements about our products, markets, strategy and operating results. Such statements are based on current expectations that involve risks and uncertainties including, but not limited to, those associated with: management of growth and international operations (including currency fluctuations and logistics), variability of our operating results, commercial development of our markets (including applied testing, clinical and academic research, proteomics, women's health/HPV testing and molecular diagnostics), our relationships with customers, suppliers and strategic partners, competition, changes in technology, fluctuations in demand, regulatory requirements, identifying, developing and producing integrated products differentiated from our competitors' products, market acceptance of our products, and integration of acquired technologies and businesses. For further information, refer to our filings with the SEC, including our latest Form 20-F. Information in this release is as of the date of the release, and we undertake no duty to update this information unless required by law.


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