QIAGEN receives FDA clearance for QIAstat-Dx respiratory syndromic testing panel for fast and accurate results
May 13 2024 - 2:00AM
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
that the U.S. Food and Drug Administration (FDA) has cleared the
QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use.
The QIAstat-Dx Respiratory Panel Plus is
designed to support clinical decision-making in diagnosing upper
respiratory infections and covers 21 viral and bacterial targets.
It was previously authorized under a U.S. FDA Emergency Use
Authorization (EUA) as the QIAstat-Dx Respiratory SARS-CoV-2 Panel.
The panel leverages QIAstat-Dx’s ability to quickly amplify many
genetic targets at once using real-time PCR technology, delivering
results in about one hour and with less than one minute of hands-on
time. Cycle threshold (Ct) values and amplification curves are
easily viewable and provide healthcare professionals with
additional clinical information.
“The QIAstat-Dx Respiratory Panel Plus addresses
the challenges faced by clinicians in diagnosing respiratory
infections, streamlining the process and providing accurate results
in about one hour,” said Fernando Beils, Senior Vice President and
Head of the Molecular Diagnostics Business Area at QIAGEN. “This
comprehensive diagnostic tool will improve patient care, support
responsible antimicrobial stewardship, and reduce the burden on
healthcare systems.”
Respiratory tract infections are the leading
cause of emergency department visits and hospitalizations. The CDC
estimates that up to 41 million cases of influenza occur each year
in the U.S., leading to several hundred thousand hospitalizations
and up to 51,000 deaths.[1]
QIAGEN is working on expanding its portfolio for
QIAstat-Dx in the U.S., with a Gastrointestinal Panel currently
under FDA review and a Meningitis/Encephalitis Panel.
Syndromic testing systems like QIAstat-Dx have
been shown to improve the detection of co-infections, reducing the
need for additional testing. By providing fast results, syndromic
testing enables healthcare providers to make informed decisions and
discontinue empiric antibiotic treatment when viral pathogens are
detected, reducing overall antibiotic usage and supporting the goal
of responsible antimicrobial stewardship.
QIAGEN recently launched the QIAstat-Dx Analyzer
2.0 [2]. The upgraded diagnostic system introduces the Remote
Results Application, a unique feature in the syndromic testing
space. It allows users to view, comment on, and confirm diagnostic
test results directly from their desktop and mobile devices in any
location, facilitating seamless collaboration across the healthcare
system. QIAstat-Dx syndromic testing with cloud-based connectivity
and epidemiological insights is available in more than 100
countries, with more than 4,000 instruments placed worldwide.
QIAstat‑Dx is available in two formats: the
QIAstat-Dx Analyzer version, which integrates up to four Analytical
Modules, and the QIAstat-Dx Rise higher-capacity version, providing
comprehensive testing for up to 160 tests per day using eight
Analytical Modules [2].
More information on the QIAstat-Dx portfolio can
be found
here: https://www.qiagen.com/applications/syndromic-testing/products
[1] Centers for Disease Control and Prevention: “Disease burden
of flu”, https://www.cdc.gov/flu/about/burden/index.html[2] Product
availability may differ from country to country based on
regulations and approvals.
About QIAGEN
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, 2024, QIAGEN employed approximately 5,900 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, timing for launch
and development, marketing and/or regulatory approvals, financial
and operational outlook, growth and expansion, 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; actions of governments, global or
regional economic developments, weather or transportation delays,
natural disasters, political or public health crises, and its
impact on the demand for our products and other aspects of our
business, or other force majeure events; as well as the possibility
that expected benefits related to recent or pending acquisitions
may not materialize as expected; and the other factors discussed
under the heading “Risk Factors” contained in Item 3 of our most
recent Annual Report on Form 20-F. 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.
Source: QIAGEN N.V.Category: Corporate
John Gilardi
QIAGEN N.V.
+49 2103 29 11711
ir@qiagen.com
Domenica Martorana
QIAGEN N.V.
+49 2103 29 11244
ir@qiagen.com
Thomas Theuringer
QIAGEN N.V.
+49 2103 29 11826
pr@qiagen.com
Daniela Berheide
QIAGEN N.V.
+49 2103 29 11676
pr@qiagen.com
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