Friday, March 31, 2017
QIAGEN N.V. announced it has joined CANCER-ID, a public-private consortium aiming to establish standard protocols and clinical validation for blood-based biomarkers in lung and breast cancer.
Rapid advances in the use of liquid biopsies, which enable cancer treatment and monitoring through the identification of circulating tumor cells and tumor-related nucleic acids in blood samples, have highlighted the need for standardized methods and workflows to avoid unreliable or even false analytical test results, including sequencing bias. The CANCER-ID consortium of 36 partners from 13 countries is a project of Europe’s Innovative Medicines Initiative (IMI) and will conduct clinical trials using liquid biopsy methods as part of its efforts to accelerate the development of better and safer medicines for patients.
“QIAGEN is pleased to be joining CANCER-ID to help develop standards and conduct clinical validation to enable broad adoption of reliable molecular analyses from liquid biopsies. Personalized healthcare is providing life-saving genomic insights, and blood-based biomarkers offer the potential to transform diagnosis and patient monitoring due to significantly easier access,” said Markus Sprenger-Haussels, Senior Director and Head of Sample Technologies in the Life Sciences Business Area.
“Creating standardized methods for liquid biopsies, as well as standards for Sample to Insight workflows, is key to enabling routine with the highest quality samples, up-front processing and links to analytical tests that are critical for achieving actionable insights. As a pioneer in developing liquid biopsy sample technologies, we look forward to sharing QIAGEN’s experience with our colleagues in CANCER-ID and contributing a wide range of solutions that can help to improve outcomes for cancer patients.”
The consortium’s scientific coordinator, Prof. Dr. Klaus Pantel, Director of the Institute of Tumor Biology at the University Medical Center Hamburg-Eppendorf in Germany, stated: “We welcome the participation of QIAGEN, which has a long track record in setting standards in sample processing and in molecular testing solutions. CANCER-ID is an excellent example of a public-private partnership enabling a collaborative research approach to come up with novel concepts in modern cancer therapy. The consortium brings together a large, experienced team of experts from academic and clinical research, innovative small- to medium-sized enterprises, diagnostics and pharmaceutical companies, far beyond the scope of traditional ‘one-on-one’ industry-academia collaborations.”
Liquid biopsies hold promise for use in a range of clinical applications, including disease screening in patients for whom surgical biopsy is inappropriate, or in repeated testing to monitor changes in disease status. However, protocols for implementation of liquid biopsies are currently very varied, and the collection of blood-based biomarkers has not yet been standardized. These areas need to be addressed since differences in sample processing techniques can result in material changes of nucleic acid profiles and cause genomic bias in subsequent sequencing. CANCER-ID intends to develop standards for liquid biopsy workflows in breast and lung cancer to support downstream applications such as next-generation sequencing (NGS) and polymerase chain reaction (PCR) analysis. The consortium also partners with clinical studies to validate the use of liquid biopsies to identify relevant cancer biomarkers.
QIAGEN is the only company providing basic and clinical researchers with Sample to Insight solutions for all three emerging liquid biopsy approaches: circulating cell-free nucleic acids, circulating tumor cells and exosomes. Novel QIAGEN workflows include the gold standard QIAamp® Circulating Nucleic Acid Kit for manual extraction of circulating cell-free nucleic acids; QIAseq® cfDNA All-in-One Kit combining cell-free DNA extraction and library preparation; PAXgene® Blood ccfDNA System for whole blood collection and room temperature stabilization of circulating cell-free DNA; AdnaTest® cancer products for the enrichment and molecular characterization of circulating tumor cells; GeneRead® QIAact Actionable Insights Tumor Panel, optimized as the first complete NGS solution for analyzing either liquid biopsies or FFPE tissue samples; and QIAGEN Clinical Insight™, a bioinformatics solution backed by expertly-curated and proprietary knowledge databases. For information on these technologies, please visit www.qiagen.com.
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 December 31, 2016, QIAGEN employed approximately 4,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
About the Innovative Medicines Initiative (IMI)
The Innovative Medicines Initiative (IMI) is working to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organizations and medicines regulators.
IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI 2 programme, IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU’s research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects ‘in kind’, for example by donating their researchers’ time or providing access to research facilities or resources.
The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° , resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. www.imi.europa.eu
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).This release represents QIAGEN’s own view and neither IMI nor the European Union, EFPIA, or any Associated Partners, are responsible for any use that may be made of the information contained therein.