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 pathogen

QIAGEN N.V. 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 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. 

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 pertussis, Chlamydophila pneumoniae and Mycoplasma pneumoniae