QIAGEN Gains 510(k) Clearance by FDA for QIAstat-Dx in the U.S. and Launches System as Next Generation Platform for Syndromic Insights
GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)--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.
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John Gilardi, +49 2103 29 11711
Phoebe Loh, +49 2103 29 11457
Thomas Theuringer, +49 2103 29 11826
KEYWORD: AUSTRIA UNITED STATES EUROPE NORTH AMERICA MARYLAND GERMANY SWITZERLAND
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY ONCOLOGY PHARMACEUTICAL RESEARCH FDA SCIENCE
SOURCE: QIAGEN N.V.
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PUB: 05/20/2019 01:30 AM/DISC: 05/20/2019 01:30 AM