Molecular diagnostic testing for accurate clinical insights on
hard-to-diagnose syndromes, initial launch with respiratory panel for
detection of more than 20 pathogens
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.
Please find the full press release here.
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