QIAGEN launches novel integrated system for collection, stabilization, transport, storage and isolation of circulating cell-free DNA
PAXgene Blood ccfDNA enhances handling and workflow convenience for liquid biopsy applications in prenatal testing and cancer research
Hilden, Germany, and Germantown, Maryland, July 27, 2016 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the new PAXgene® Blood ccfDNA Tube* for venous whole blood collection and room temperature stabilization of in-vivo circulating cell-free DNA (ccfDNA) profiles. Together with the QIAamp Circulating Nucleic Acid Kit – the gold standard in manual extraction of circulating cell-free DNA – and upcoming new automated ccfDNA isolation on the QIAsymphony, PAXgene Blood ccfDNA builds a fully integrated and complete standardized system covering all pre-analytical workflow steps from blood collection, stabilization, transport, storage and isolation of high quality ccfDNA.
The new system contains a unique non-crosslinking reagent in the collection tube that ensures DNA remains unmodified. It prevents post-collection release of genomic DNA from white blood cells – resulting in improved ccfDNA yield recovery with less background DNA. A minimized release of contents of ruptured red blood cells into blood plasma (hemolysis) enables a maximized plasma recovery, particularly critical in cancer research. Combined with the proven plastic BD Vacutainer® Tube technology, customers will benefit from consistent blood draws and no more glass tube breakage during the workflow.
The new preanalytical system significantly expands the range of liquid biopsy applications: While most other ccfDNA stabilization approaches contain potential formaldehyde releasing compounds – which make them unsuitable for many applications – the new PAXgene tube with its novel reagents is compatible with a wide array of downstream applications such as non-invasive prenatal testing (NIPT) or methylation-based assays in cancer research.
“Researchers performing ccfDNA analysis today are facing a number of severe pre-analytical workflow challenges: They need to prevent fast post-collection changes of ccfDNA profiles which can lead to unreliable analytical results. They need blood collection tubes with stabilization if they can’t separate blood from plasma in time. They need stabilization reagents not limiting their analytical downstream performance due to cross-linking, they need safe tube handling and high-quality isolation of complete ccfDNA profiles. But above all, they want a complete and fully integrated solution for all these steps”, said Brad Crutchfield, Senior Vice President and head of QIAGEN’s Life Sciences Business Area. “Our novel, completely integrated preanalytical system provides them with unseen application opportunities, safety levels, and workflow convenience – an important solution to further drive ccfDNA analysis in prenatal testing, cancer and many other clinical research areas. QIAGEN is leading the way in providing liquid biopsy solutions to take labs from Sample to Insight.”
“Securing high quality samples with preserved analyte profiles through integrated pre-analytical systems covering all workflow steps is a key prerequisite for reliable and valid analytical testing results” said Frank Augello, General Manager of PreAnalytiX GmbH (A QIAGEN / BD joint venture company) which developed the new system. “The PAXgene Blood ccfDNA System adds to the proven track record of pre-analytical systems powered by PreAnalytiX, which also includes solutions for various sample types and analytes, such as the gold standard PAXgene Blood RNA System for intracellular RNA analysis from whole blood”.
The new preanalytical system also complements a broad number of new liquid biopsy solutions QIAGEN is launching across the Sample to Insight value chain, including new QIAseq targeted panels using proprietary and innovative digital NGS technology.
QIAGEN is the only company providing Sample to Insight solutions in all three emerging approaches to liquid biopsies: circulating cell free nucleic acids, circulating tumor cells (CTCs) and exosomes. Its portfolio of liquid biopsy solutions continues to grow rapidly. In June, QIAGEN introduced its liquid biopsy workflow for the QIAact Actionable Insights Tumor Panel, tracking a broad range of biomarkers in clinical research to add valuable insights on the progression of the most common cancers.
* PAXgene Blood ccfDNA Tube is for Research Use Only (RUO).
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of March 31, 2016, QIAGEN employed approximately 4,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Certain statements contained in this press 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, collaborations, markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions 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, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; 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 general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; 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 and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).