QIAGEN launches novel product enabling non-invasive prenatal diagnostics and cancer detection

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.