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 Mini test for clinical use. It is the
third test to receive FDA clearance for use with QIAstat-Dx systems
in 2024.
The QIAstat-Dx Respiratory Panel Mini is
designed to support clinical decision making in diagnosing upper
respiratory infections in outpatient settings and covers five
common viral causes of illness: influenza A, influenza B, human
rhinovirus, respiratory syncytial virus (RSV) and SARS-CoV-2. The
panel leverages QIAstat-Dx’s ability to quickly multiply many
genetic targets using real-time PCR technology in the same
reaction, delivering results in about one hour and with less than
one minute of hands-on time. Cycle threshold (Ct) values and
amplification curves provide laboratories with additional
information in the context of co-infections, and are instantly
viewable on the instrument touchscreen with no additional software
required.
The QIAstat-Dx Respiratory Panel Mini is the
second QIAstat-Dx respiratory panel to receive FDA clearance this
year. While the comprehensive 21-target QIAstat-Dx Respiratory
Panel Plus is highly suitable for hospitalized patients with risk
factors for severe disease, the more targeted QIAstat-Dx
Respiratory Panel Mini offers a streamlined approach for diagnosing
the five most actionable pathogens causing upper respiratory
infections. This makes it an invaluable tool in outpatient
settings, where its efficiency can benefit the widest possible
patient population. The two FDA-cleared tests together effectively
tackle the unique challenges that clinicians encounter when
diagnosing respiratory infections in both outpatient and inpatient
settings.
“The QIAstat-Dx Respiratory Panel Mini and
QIAstat-Dx Respiratory Panel Plus will improve diagnostic
stewardship by enabling clinicians to tailor testing to each
patient's unique needs, choosing between a full, comprehensive
panel or a more targeted one,” said Nadia Aelbrecht, Vice President
and Head of the Syndromic Testing Franchise at QIAGEN. “By
streamlining the diagnostic process and delivering accurate results
in about an hour for both outpatient and inpatient groups, these
tests will enhance patient care, promote responsible antimicrobial
stewardship and alleviate the strain 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]
Syndromic tests like QIAstat-Dx have been shown
to improve the detection of infections, including those involving
multiple pathogens, reducing the need for additional testing. By
providing fast results, syndromic testing enables healthcare
providers to make informed treatment decisions and discontinue
empiric antibiotic treatment when viral pathogens are detected,
reducing overall antibiotic usage and supporting the goal of
responsible antimicrobial stewardship.
QIAGEN is expanding its portfolio for QIAstat-Dx
in North America, with the recent launch of the QIAstat-Dx Analyzer
2.0, FDA clearance of the Gastrointestinal Panel 2 and submission
for FDA clearance of the Meningitis/Encephalitis Panel. Submission
for FDA clearance of the Gastrointestinal Panel Mini is planned
before the end of this year.
After its launch in Europe in spring 2024, the
QIAstat-Dx Analyzer 2.0 is now also available in the U.S. for use
with the QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx
Gastrointestinal Panel 2. An extension for use with the QIAstat-Dx
Respiratory Panel Mini is already planned. 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.The QIAstat-Dx Rise
higher‑capacity version provides comprehensive testing for up to
160 tests per day using eight Analytical Modules instead of four.
It is available with CE-IVD marking in Europe as well as other
countries that accept this marking and is planned for submission to
the FDA in 2025. [2] 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.
More information on the QIAstat-Dx portfolio can
be found here:
https://www.qiagen.com/product-categories/diagnostics-and-clinical-research/infectious-disease/qiastat-dx-syndromic-testing
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
June 30, 2024 QIAGEN employed more than 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
[1]https://www.cdc.gov/flu/about/burden/index.html, as of June
28, 2024[2] Product availability may differ from country to country
based on regulations and approvals.
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
Lisa Specht
QIAGEN N.V.
+49 2103 29 14181
pr@qiagen.com
Qiagen NV (NYSE:QGEN)
과거 데이터 주식 차트
부터 12월(12) 2024 으로 1월(1) 2025
Qiagen NV (NYSE:QGEN)
과거 데이터 주식 차트
부터 1월(1) 2024 으로 1월(1) 2025