QIAGEN gains 510(k) clearance by FDA for QIAstat-Dx in the U.S. and launches system as next generation platform for syndromic insights
May 20 2019

QIAGEN gains 510(k) clearance by FDA for QIAstat-Dx in the U.S. and launches system as next generation platform for syndromic insights

Molecular diagnostic testing for accurate clinical insights on hard-to-diagnose syndromes, initial launch with respiratory panel for detection of more than 20 pathogens

Germantown, Maryland, and Hilden, Germany, May 20, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of its QIAstat-Dx syndromic testing system after receiving 510(k) clearance by the U.S. Food and Drug Administration, along with the multiplex QIAstat-Dx® Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens.

QIAstat-Dx (formerly Stat-Dx DiagCORE®) represents the next-generation in multiplex molecular diagnostic systems that enables fast, cost-effective and flexible syndromic testing with novel Sample to Insight solutions powered by QIAGEN chemistries. The system, based on the proprietary DiagCORE® technology, received CE-IVD marking in January 2018 and already has a significant installed base.

QIAstat-Dx is being launched in the U.S. with a comprehensive respiratory panel that detects more than 20 pathogens. The panel is the first test in a deep and broad pipeline of planned assays for QIAstat-Dx in the U.S., with plans to launch a gastrointestinal panel later in 2019. With the ability to multiplex as high as 48 targets, a deep pipeline is planned that will span infectious diseases, oncology, companion diagnostics and other disease Areas.

Demand for syndromic testing with molecular diagnostics is growing rapidly, to accurately evaluate infections and other diseases that manifest as a set of symptoms with uncertain causes. According to the U.S. Centers for Disease Control (CDC), as many as 35 million cases of influenza each year lead to several hundred thousand hospitalizations and as many as 56,000 deaths in the U.S.. The CDC uses estimates of flu cases because most respiratory infections are not diagnosed or reported with precision as part of the agency’s disease surveillance system. In respiratory syndromes and flu testing, QIAGEN estimates the total addressable market at about 1.5 million tests per year in the United States.

“QIAstat-Dx delivers the precision of molecular testing to identify hard-to-diagnose respiratory infections, which sicken millions of U.S. patients each year and kill tens of thousands. We are pleased to roll out the QIAstat-Dx Respiratory Panel for healthcare providers as they begin to prepare for the 2019-20 flu season,” said Thierry Bernard, Senior Vice President and Head of Molecular Diagnostics for QIAGEN. “DiagCORE has been enthusiastically received in Europe and other regions of the world for its rapid, clear insights in clinics and other near-patient settings, as well as its cost-efficiency. We now look forward with the launch of QIAstat-Dx to similar success in the U.S. QIAstat-Dx will provide physicians with results to aid in the appropriate diagnosis and treatment for each patient. We are developing a deep menu of additional multiplex panels, such as tests for gastrointestinal syndromes and meningitis infections.”

QIAstat-Dx significantly improves syndromic testing workflows for customers:

  • Powerful capabilities – QIAGEN sample and assay technologies deliver true Sample to Insight evaluation with real-time PCR (polymerase chain reaction).
  • Ease of use – A lab technician loads a clinical sample into a single-use QIAstat-Dx cartridge and places it in the analyzer, requiring less than one minute of hands-on time. Sample processing is built in, all reagents are on-board, and the technician’s workflow is intuitive.
  • Speed – QIAstat-Dx is designed to operate in a range of near-patient clinical settings, eliminating the delay of sending samples to a centralized laboratory. Results are available in about one hour.
  • Cost-efficiency – QIAstat-Dx cartridges offer significantly lower costs compared to other systems, a benefit for healthcare providers in the current reimbursement landscape. Connectivity and bi-directional integration into laboratory information systems add further efficiencies.
  • Flexibility – Cartridges are processed in a scalable, proprietary and fully integrated platform that can be configured from one to four modules, depending on the volume needed. QIAstat-Dx is designed for an expanding test menu in the future with the potential ability to process up to 48 targets simultaneously. 

QIAGEN will demonstrate the QIAstat-Dx system and its capabilities at these upcoming U.S. conferences:

  • American Society of Microbiology (ASM) – June 20-24, San Francisco, California
  • American Association of Clinical Chemistry (AACC) – August 4-8, Anaheim, California

The QIAstat-Dx Respiratory Panel is a multiplexed nucleic acid test that evaluates nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The following pathogens and subtypes are identified using the QIAstat-Dx Respiratory Panel: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussisChlamydophila pneumoniae and Mycoplasma pneumoniae.

For more information, please visit www.QIAstat-Dx.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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2019, QIAGEN employed approximately 5,100 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

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).


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