QIAGEN Offers Clinical Labs Early Access to New Ingenuity Solution for Streamlined Interpretation of Patient Sequencing Data

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Nov 13, 2013, 08:19 ET

PHOENIX, Arizona, REDWOOD CITY, California and HILDEN, Germany, November 13, 2013 /PRNewswire/ --

New web-based product delivers fast and high-confidence interpretation and reporting of variants from next-generation sequencing data for molecular pathologists and medical geneticists

Early access program of clinical interpretation and reporting solution will conclude by year-end, paving the way for early 2014 launch of larger beta program

QIAGEN also announces Ingenuity Scientific Advisory Board to guide development of new clinical interpretation and reporting solutions

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has begun enrolling molecular diagnostics laboratories in an Early Access Program to complete the development of a new web-based solution to deliver faster, easier-to-use and high-confidence clinical interpretation and reporting of observed gene variants in data from next-generation sequencing (NGS)-based tests. QIAGEN is announcing the program at the annual meeting of the Association for Molecular Pathology (AMP) taking place November 14-16 in Phoenix, Arizona.

QIAGEN also announced the formation of the Ingenuity Scientific Advisory Board, made up of healthcare and academic leaders in medical genetics, genomics and bioinformatics. This board will advise and assist the Company in research and product development initiatives focused on clinical applications.

"NGS is a transformative medical tool with the potential to improve patient outcomes by accurately detecting and characterizing diseases at earlier stages, but the challenge in diagnostic labs is to efficiently sift through huge amounts of data and extract high-confidence, actionable answers," said Sean Scott, Senior Vice President of Business Development at QIAGEN Redwood City. "This new solution will simplify and streamline the interpretation and reporting process and provide consistent, high-quality and actionable results for use in clinical research and decision making."

The new interpretation and reporting solution draws upon the vast clinical and genomic data in the expert-curated Ingenuity Knowledge Base. It will be the first product in the Ingenuity portfolio that is specifically designed to address major challenges of scale, speed and decision support that healthcare laboratories face with the adoption of NGS-based applications. The time required to make accurate clinical assessments of variants - 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 adoption of these data in clinical applications. The new solution will provide clinical labs with automated scoring, interpretation and reporting of findings in standardized, HIPAA Safe Harbor-compliant formats.

Early Access Program members include leading commercial and academic testing labs including Emory Genetics Laboratory, GeneDx, LabCorp, Partners Healthcare and Quest Diagnostics. These collaborators provided important input into the development of the Ingenuity solution. A larger beta program will launch in early 2014, and interested laboratories can learn more at http://wptest.ingenuity.com/ngs-clinical-beta.

"I am excited to join my esteemed colleagues on the Scientific Advisory Board and to continue working closely with the Ingenuity team on the rollout of this powerful new application," said Dr. Sherri Bale, a medical geneticist who is Managing Director and Co-founder of GeneDx and Senior Vice President of BioReference Laboratories. "It will relieve a critical bottleneck and get actionable genomic information into the hands of clinicians."

The Ingenuity Scientific Advisory Board includes:

Sherri Bale, Ph.D., FACMG, Managing Director and Co-founder, GeneDx; Senior Vice President, BioReference Laboratories; Founding Member of the American College of Medical Genetics
Doug Bassett, Ph.D., SAB Chairman, Chief Technology and Scientific Officer, QIAGEN Redwood City
Hakon Hakonarson, M.D., Ph.D., Director of the Center for Applied Genomics; Associate Professor of Pediatrics, The Perelman School of Medicine, University of Pennsylvania
Madhuri Hegde, Ph.D., FACMG, Professor, Emory University School of Medicine, Department of Human Genetics; Executive Director of the Emory Genetics Laboratory
Elaine R. Mardis, Professor of Genetics and Molecular Microbiology, Co-director, The Genome Institute at Washington University School of Medicine
Heidi L. Rehm, Ph.D., FACMG, Associate Professor of Pathology, Harvard Medical School; Laboratory Director, Partners Healthcare Center for Personalized Medicine, Harvard Medical School
Eric Schadt, Ph.D., Director of the Icahn Institute for Genomics and Multiscale Biology, Chair of the Department of Genetics and Genomics Sciences and the Jean C. and James W. Crystal Professor of Genomics.
Jay Shendure, M.D., Ph.D., Associate Professor of Genome Sciences, University of Washington; Affiliate Professor, Division of Human Biology, Fred Hutchinson Cancer Research Center

Representatives of QIAGEN Redwood City will discuss the new clinical interpretation solution at the AMP annual meeting in exhibition stand 1016 and in a corporate workshop on Wednesday, November 13. For more information please visit http://www.ingenuity.com/AMP-2013

About QIAGEN Redwood City

QIAGEN Redwood City, formerly Ingenuity Systems, is based in Redwood City, California. As the company's Center of Excellence in Biological Analysis and Interpretation, QIAGEN Redwood City is a leading provider of biomedical information and analysis solutions for the exploration, interpretation and analysis of complex biological systems in life science research and now moving towards molecular diagnostics. Marketed under the Ingenuity brand, these innovative solutions offered by QIAGEN are used by tens of thousands of researchers and clinicians at hundreds of leading pharmaceutical, biotechnology, academic, and clinical institutions worldwide. Further information can be found at http://www.qiagen.com/ingenuity

About QIAGEN

QIAGEN N.V. is a Netherlands holding company publically traded on NASDAQ and Frankfurt Prime Standard. The Company is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular insights. 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 September 30, 2013, QIAGEN employed more than 4,100 people in over 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).