QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio
March 29 2021 - 2:00AM
Business Wire
- NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test receives Emergency
Use Authorization by FDA
- The 4-plex test utilizes the high-throughput, automated testing
capabilities of the NeuMoDx systems, which has a growing and
comprehensive assay menu for respiratory, blood-borne virus,
transplant, and reproductive health disease areas
- Test adds to QIAGEN’s expanding portfolio of PCR testing
solutions for COVID-19 testing
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced the Emergency Use Authorization by the U.S. FDA for the
NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Assay that will help
healthcare professionals quickly identify and differentiate
individuals suspected by a healthcare provider of respiratory viral
infection consistent with COVID-19.
As restrictions are eased and social distancing measures are
reduced, respiratory viral infections are likely to increase.
Clinical signs and symptoms of respiratory viral infection due to
SARS-CoV-2, influenza or RSV can be similar. This makes it
essential to correctly identify them in order to treat and manage
patients accordingly, especially in the COVID-19 pandemic. This
polymerase chain reaction (PCR) multiplex test will be an important
tool now and in upcoming winter seasons for simultaneous
qualitative detection and differentiation of influenzas A and B,
respiratory syncytial virus (RSV) and SARS-CoV-2 infections within
80 minutes.
QIAGEN launched the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test
in the European Union and other markets that accept CE-IVD in
November 2020 and will now begin commercialization of the test in
the U.S.
QIAGEN’s new respiratory test takes advantage of the NeuMoDx 96
and NeuMoDx 288 molecular systems’ automated three-step workflow.
Coupled with additional system features – like processing
capacity, true random access, and continuous loading of samples,
reagents and consumables while the system is running – the NeuMoDx™
Flu A-B/RSV/SARS-CoV-2 Vantage Assay will be a powerful diagnostic
tool for the flu season and COVID-19 pandemic.
“The authorization of this new test will become a pivotal tool
for the detection and differentiation of SARS-CoV-2 from influenza
like illnesses, or ILls,” said Jean-Pascal Viola, Senior Vice
President, Head of the Molecular Diagnostics Business Area and
Corporate Business Development at QIAGEN. “This test will play an
important role in differentiating between ILI’s while the burden of
COVID-19 continues. With its ease of use and true random access,
the NeuMoDx will help laboratories maintain throughput for this
increased testing volume while continuing routine testing. Also,
with the continued ramp up of our manufacturing capacity, the
NeuMoDx will be ready to answer the needs of molecular diagnostic
laboratories for 2021 and beyond.”
The new 4-plex test joins a growing menu of assays on the
NeuMoDx platform, which includes tests for blood-borne viruses,
sexual and reproductive health, transplant and immunocompromised
disease areas. More tests are in development and expected to launch
in the coming months, including VZV, adenovirus and others.
QIAGEN fully acquired NeuMoDx in September 2020 and made it one
of its five growth drivers for the company to continue growing on a
standalone basis – the others being Sample Prep, QIAcuity, QFT and
QIAstat-Dx. The NeuMoDx™ Flu A-B/RSV/ SARS-CoV-2 Vantage Test
strengthens QIAGEN’s footprint in PCR, the gold standard in
coronavirus testing.
QIAGEN has a broad portfolio of testing and research solutions
for COVID-19, ranging from fast singleplex and multiplex PCR tests
to fast syndromic solutions (QIAstat-Dx), providing customers with
a broad variety of PCR-based testing options. Furthermore, the
portfolio includes RNA extraction kits and instruments as well as
testing components and enzymes used by third parties for their own
PCR test kits. QIAGEN’s COVID-19 portfolio also includes the
QIAreach Antibody and Antigen tests, as well as SARS-CoV-2 T-Cell
tests based on the QuantiFERON IGRA technology. In October 2020,
the company also launched QIAprep& which streamlines PCR
workflows by integrating sample preparation and real-time PCR
detection into a single kit. QIAGEN also provides NGS solutions for
research into mutations of COVID-19, dPCR solutions for wastewater
testing and bioinformatics with QDI.
Further information on QIAGEN’s response to the coronavirus
outbreak can be found here.
For more information on the NeuMoDx platform and NeuMoDx™ Flu
A-B/RSV/SARS-CoV-2 Vantage Test, please visit
http://qiagen.com/NeuMoDx
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 December 31, 2020, QIAGEN
employed more than 5,600 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, 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. 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 (SEC).
Category: Corporate
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version on businesswire.com: https://www.businesswire.com/news/home/20210328005030/en/
Investor Relations John Gilardi +49 2103 29 11711 Phoebe
Loh +49 2103 29 11457 e-mail: ir@QIAGEN.com
Public Relations Thomas Theuringer +49 2103 29 11826
Robert Reitze +49 2103 29 11676 e-mail: pr@QIAGEN.com
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