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21st May 2019  Content supplied by: QIAGEN Benelux B.V.

FDA Clearance for QIAstat-Dx Respiratory Panel that Detects More than 20 Pathogens

QIAGEN N.V. have 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.

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.

  • 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.

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Date Published: 21st May 2019

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