MARCO ISLAND, Florida and HILDEN, Germany, February 12, 2014 /PRNewswire/ --
- Significant expansion of 'universal' portfolio compatible with any NGS system includes several novel sample preparation products as well as solutions for clinical use
- New bioinformatics solutions, including CLC Cancer Research Workbench and Ingenuity Clinical will accelerate analysis and interpretation of NGS data
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the launch plans of several novel products designed to significantly reduce the challenges of the most significant bottlenecks in next-generation sequencing (NGS): sample preparation and bioinformatics. The solutions will enable NGS users to generate more valuable insights from any sample. The new products add to QIAGEN's rapidly expanding portfolio of 'universal' solutions designed to run with any NGS platform, including QIAGEN's GeneReader™ platform, which is being prepared for launch in 2014. Several of QIAGEN's new NGS products will be introduced to genomics researchers this week at the 15th annual Advances in Genome Biology and Technology (AGBT) meeting in Marco Island, Florida.
A recent survey of more than 900 participants published on ngsperspectives.com points out that access to clinical samples (23 percent) and analysis of complex NGS data (26 percent) are seen as the biggest bottlenecks among NGS users. QIAGEN is targeting exactly these challenges with a product development strategy that builds on the company's recognized leadership in bioinformatics and sample preparation (sample technologies, enrichment and library preparation) and will be available to all NGS users as universal workflow products.
"By solving these user challenges, QIAGEN is building very robust NGS workflows for routine use in clinical applications and clinical research. Universal products support any NGS platform - with capabilities to allow the processing of even the most difficult samples and to seamlessly integrate the analysis and interpretation of sequencing data," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "Our leading capabilities in sample and assay technologies provide new dimensions of quality for sample collection and isolation and for what is known in NGS workflows as sample preparation (enrichment and library preparation). In addition, our newly created leading position in bioinformatics can significantly improve the performance of all major platforms and also tie into QIAGEN's integrated sample-to-insight GeneReader™ NGS workflow, which is progressing in development."
At the AGBT meeting, QIAGEN will present a luncheon seminar on Saturday, February 15, featuring leading scientists discussing their use of QIAGEN NGS sample technologies, GeneRead custom panels, and Ingenuity and CLC bioinformatics products to enhance their workflows.
Improving Sample Access
Gaining access to adequate amounts of high-quality sample material often is a challenge to all NGS applications. As the industry's leader in innovative sample technologies for collection, stabilization, isolation, purification and storage of samples, QIAGEN has created several new products designed specifically to help NGS users deal with difficult-to-handle samples, including:
- GeneRead DNA FFPE Kit provides a streamlined, easy-to-use procedure for efficient purification of DNA from formalin-fixed, paraffin-embedded (FFPE) tissue sections. Formalin treatment and storage introduce cytosine deamination, which leads to DNA sequence changes and potentially wrong data interpretation. An enzymatic step in the procedure eliminates these molecules from further analysis and reduces those effects significantly. QIAGEN has already shown dramatic improvements of data quality in several studies and will be sharing further data. Additionally the new GeneRead kit enables an increase of DNA yield. The GeneRead DNA FFPE Kit is now available.
- REPLI-g®WTA Single Cell Kit and REPLI-g®Cell WGA & WTA Kit enable transcriptomic NGS analysis from single cells and comparative genomic and transcriptomic analysis from the same small sample. Both kits expand the REPLI-g single cell kit portfolio, which can make single cells accessible to NGS analysis by amplifying either DNA or RNA from individual cells. Using QIAGEN´s proprietary MDA with the new SensiPhi polymerase (1,000-fold higher accuracy than Taq polymerase), the amplified nucleic acids show comparable performance to the original molecules, which allows users to perform multiple experiments from a single cell reliably and reproducibly. The REPLI-G WTA Single Cell Kit and the REPLI-g Cell WGA & WTA Kit are now available.
- Exosome sample-preparation kits enable processing of nucleic acids from exosomes, tiny messenger packages in a biological communication system that transmits genetic instructions from cell to cell. The kits will combine QIAGEN's proven sample technologies with technology developed by Exosome Diagnostics Inc. that allows non-invasive detection of key gene mutations and gene expressions in blood, urine and cerebrospinal fluid without the need for a risky and burdensome surgical tissue biopsy. The first kits will be launched in the second quarter of 2014.
Enhancing Variant Identification
QIAGEN also announced plans to launch a line of GeneRead DNAseq panels V2.0 in the second quarter of 2014. This second-generation line of products provides an easy-to-use, highly sensitive and specific PCR-based target enrichment approach compatible with any NGS platform. The 14 new gene panels target a broad range of relevant genetic variants for clinical research.
The GeneRead DNAseq panel V2.0 provides the most extensive collection of wet-bench verified catalog gene panels, covering actionable cancer mutations, clinically-relevant tumor mutations, tissue-specific cancers, comprehensive cancer, cancer predisposition, comprehensive carrier testing, and cardiomyopathy. Researchers also can design customized panels to meet their specific needs.
GeneRead DNAseq panels use as little as 10 ng of starting DNA material, generate small amplicons (~150 bp), and enable preparation of NGS libraries ready for sequencing within one day, making these products an ideal approach for sequencing FFPE samples in clinical research with any NGS sequencer. The panels are further supported by launch of the GeneRead DNAseq V2 chemistry, which along with the panels offers enhanced NGS performance metrics in terms of uniformity and specificity.
Demonstrating Bioinformatics Leadership
QIAGEN also announced important new additions to its leading position in the emerging market for bioinformatics solutions for analysis and interpretation of NGS data in clinical research. Building on its acquisitions of Ingenuity and CLC bio in 2013, QIAGEN is helping a broad range of NGS customers achieve valuable insights from their sequencing data. QIAGEN is discussing these new products at the AGBT meeting:
- CLC Cancer Research Workbench is the world's first comprehensive, user-friendly and customizable cancer-focused bioinformatics solution. Expected to launch in April 2014, it offers flexible, cancer-specific, ready-to-use analysis workflows that can be modified or personalized by the user. Advanced resequencing tools, in combination with an intuitive graphical user interface, allow rapid analysis and accurate interpretation of advanced NGS data.
CLC Cancer Research Workbench provides scientists and clinicians with the tools to identify prognostic markers, identify subclonal somatic mutations, detect inherited traits, find biomarkers for drug response, and determine new oncogenes. The software also enables all results to be filtered, visualized, and compared with relevant databases.
- Ingenuity® Clinical is a new web-based solution designed to deliver faster, easier-to-use and high-confidence clinical interpretation and reporting of insights from NGS-based tests. QIAGEN began collaborating with molecular diagnostics laboratories in the development of this exciting new product in November 2013, and announced plans for a 2014 launch of a larger beta program for Ingenuity Clinical. Collaborators providing important input include several commercial and academic testing laboratories: More than 20 clinical testing laboratories are currently participating in the Ingenuity Clinical early access program. Test indications supported have expanded from hereditary/germline to somatic NGS panels including hereditary cancer, somatic cancer, carrier screening, cardiovascular and neurological test indications.
Drawing upon the vast clinical and genomic data in the expert-curated Ingenuity Knowledge Base, Ingenuity Clinical will be the first product specifically designed to address challenges of scale, speed and decision support that healthcare laboratories face in the adoption of NGS. The time required to make accurate clinical assessments - especially as tests move from single-gene to multiple-gene to panels, exomes and whole genomes - is becoming a fundamental bottleneck and is slowing the clinical adoption of NGS. The new solution will provide clinical labs with automated scoring, interpretation and reporting of findings in standardized, HIPAA Safe Harbor-compliant formats.
- Ingenuity® Variant Analysis™ adoption rates continue to accelerate at leading institutions around the world, based on its broad utility and benefit in analyzing and interpreting human sequencing data. Since the AGBT meeting two years ago more than 200,000 samples have been uploaded into Ingenuity Variant Analysis by more than 2,000 users, including more than 600 institutions and drug discovery companies engaged in all stages of basic, translational and clinical research - making Ingenuity Variant Analysis by far the solution of choice for NGS data interpretation.
These NGS products are all part of QIAGEN's portfolio of universal solutions, compatible with any next-generation sequencer and adding value to any NGS workflow.
QIAGEN also is developing the benchtop GeneReader™ NGS platform for clinical research applications. Combined with QIAGEN's other NGS products, it will provide the first seamless automated workflow from biological sample, through DNA preparation, enrichment, library preparation, sequencing, data analysis and interpretation, to deliver valuable insights into diseases. Commercialization is planned for 2014.
For more information on QIAGEN's NGS products and resources, please visit http://www.qiagen.com/goto/NGS.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of December 31, 2013, QIAGEN employed approximately 4,000 people in more than 35 locations worldwide. Further information can be found at http://www.QIAGEN.com/.
Certain of the statements contained in this news 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, markets, strategy or operating results, including without limitation its expected operating 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 inapplied testing, personalized healthcare, clinical research,proteomics, women's health/HPVtesting andnucleic acid-basedmolecular 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, the consummation of acquisitions, 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).