9 JANUARY 2017
QIAGEN announces comprehensive range of enhancements for GeneReader NGS System
Launch of new QIAact gene panels and customized panels service complemented by performance upgrades that further differentiate first Sample to Insight NGS sequencing solution
Germantown, Maryland, and Hilden, Germany, January 9, 2017 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced a comprehensive range of enhancements for the GeneReader NGS System* – in particular the launch of new gene panels that will create a full menu for oncology applications – that are designed to significantly improve the utility, efficiency and cost-effectiveness of the world’s first Sample to Insight next-generation sequencing (NGS) solution.
QIAGEN also announced that it achieved the target set for 55-60 GeneReader NGS Systems placements with customers worldwide at the end of 2016 following the start of commercialization in late 2015. This represents more than a 10% share of the estimated global annual market for new placements of benchtop sequencer used for oncology applications.
“We are very pleased with the response of customers to the GeneReader NGS System, which has confirmed our strategic decision to provide a simpler, more cost-effective way for any laboratory worldwide to take advantage of NGS technology and improve outcomes,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “This comprehensive range of enhancements will further differentiate the GeneReader NGS System and help customers explore the expanding content menu and ability to gain valuable molecular insights. We look forward to further expanding and enhancing the utility, efficiency and cost-effectiveness of this truly differentiated Sample to Insight solution and our NGS portfolio.”
Since 2001, ICMP has operated a state-of-the-art DNA laboratory system focused exclusively on missing persons identification. The system delivers high-throughput capabilities to assist governments in identifying large numbers of persons missing from conflict, human rights abuses, natural and manmade disasters, organized crime, irregular migration and other circumstances where persons go missing for involuntary reasons.
The system is designed to work on the most challenging cases, operates on a high-throughput scale, has generated DNA results on more than 50,000 cases of degraded skeletal remains and contributed to the identification of around 20,000 persons worldwide. ICMP’s new laboratory in The Hague aspires to maintain a capacity of up to 10,000 cases a year. Over the course of two decades, ICMP has responded to a wide variety of complex missing persons scenarios in over 40 countries, including assisting Bosnia and Herzegovina identify almost 90 percent of the approximately 8,000 victims of the Srebrenica genocide, and after the 2004 South East Asian Tsunami, in conjunction with INTERPOL, it deployed its forensic expertise as part of a major international Disaster Victim Identification program. The laboratory system is also a key component of ICMP’s Center of Excellence in Training and it supports ICMP's programs in the Western Balkans, the MENA region and Latin America.
Among the enhancements:
- New GeneRead QIAact gene panels: QIAGEN plans to commercialize at least five new gene panels during the year, many of which are compatible with both FFPE tissue samples and non-invasive liquid biopsies. This expansion plan builds on the success of the GeneRead QIAact Actionable Insights Tumor Panel, which was launched as the first expert-designed gene panel for use on the GeneReader NGS System and targets 12 clinically actionable genes in the five most prevalent solid tumors. The expansion plans include two new gene panels for deep analysis of lung cancer samples, while commercialization of a gene panel for analysis of breast and ovarian cancers is set to begin soon in Europe and later this year in the U.S. An onco-hematology panel is also being prepared for launch during 2017, while additional gene panels are in development for seamless integration with the GeneReader NGS System.
- Customized panels and related workflows: In a move that will significantly broaden the use for oncology applications, QIAGEN intends to soon begin offering services to customers for the development of customized gene panels for use on the GeneReader NGS System, this new service will also include optimization of the GeneReader NGS System to the specific needs of the customized gene panels. This new offering builds on the selection, design and digitalized commercial portal offered through QIAGEN’s GeneGlobe PCR-based assay panels, which span more than 60,000 targets across most disease areas. To date, QIAGEN has commercialized more than 40 million pre-designed molecular assays through GeneGlobe. As with the new GeneRead QIAact gene panels, the selection of genes for inclusion in panels is powered by QIAGEN’s Ingenuity Knowledge Base, the world’s leading resource for interpretation and selection of molecular content that contains more than 13 million genetic findings and has so far been used to analyze more than 350,000 molecular samples.
- Broader range of mutation analysis: QIAGEN’s gene panels have been upgraded to incorporate QIAGEN’s recently unveiled proprietary Digital NGS technology that enables more accurate quantification and detection of variants in samples. As a result, the GeneReader NGS System will be expanded to analyze a broader range of genetic variant types. These include large rearrangements (in particular exon-skipping events), gene fusions and copy number variations (CNVs), in addition to the current capabilities for single nucleotide polymorphisms (SNPs), gene expression and genomic insertions or deletions (InDels).
- Increased sample processing capacity: Among the key features of the GeneReader NGS System are the ability to process scalable batch sizes as well as the random access and continuous loading of multiple flow cells, which enable labs to adapt and scale the System to match their needs. As a result of system performance improvements, GeneReader NGS Systems customers will have the benefits of a 20% increase in sample capacity per run, which has risen to up to 48 samples per run from the current capacity of up to 40 samples per run. With a total processing capacity up to about 5,000 samples a year (two runs per week), this enhanced throughput allows the GeneReader NGS System to address the processing needs of even the highest-throughput laboratories while remaining economically attractive to even lower-throughput laboratories.
- New proprietary sequencing chemistry: QIAGEN’s new proprietary sequencing chemistry was announced in November 2016 at the Association for Molecular Pathology meeting, where QIAGEN released performance data showing 100% concordance with results of QIAGEN’s FDA-approved therascreen KRAS RGQ PCR assay, the CE-labelled therascreen RAS Extension Pyro Assay as well as with an alternative NGS sequencer from another vendor. In that study, 42 metastatic colorectal cancer FFPE samples were tested with previously confirmed RAS mutational status. The rollout of the new chemistry to customers in the United States is expected to begin during the first quarter of 2017, and to other areas of the world during the year.
This comprehensive enhancement package is planned to be rolled out in 2017 and builds on a wave of recent improvements that have included the ability to process non-invasive liquid biopsies; complete sample processing and library preparation steps with either the QIAcube or QIAsymphony SP automation platforms; and integration with laboratory information management systems (LIMS).
QIAGEN intends to develop further enhancements and improve the performance of the GeneReader NGS System – which is the only fully integrated NGS workflow that take users from automated sample and library preparation through to accurate identification and quantification of genetic variations using powerful bioinformatics for data analysis and interpretation – to create further value for labs and broaden use beyond the current focus on oncology applications.
For more information, please visit http://www.qiagen.com/us/products/ngs/mdx-ngs-genereader/ngs/.
*GeneReader NGS System: The QIAGEN GeneReader® NGS System with the legacy chemistry is available for sale and use outside the United States. It is intended for Research Use Only. This product is not intended for the diagnosis, prevention or treatment of a disease. QIAGEN Clinical Insight® is an evidence-based decision support software intended as an aid in the interpretation of variants observed in genomic sequencing data. The software evaluates genomic variants in the context of published biomedical literature, professional association guidelines, publicly available databases and annotations, drug labels and clinical-trials. Based on this evaluation, the software proposes a classification and bibliographic references to aid in the interpretation of observed variants. The software is not intended as a primary diagnostic tool by physicians or to be used as a substitute for professional healthcare advice. Each laboratory is responsible for ensuring compliance with applicable international, national and local clinical laboratory regulations and other accreditation requirements.
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 September 30, 2016, QIAGEN employed approximately 4,700 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).