QIAGEN receives FDA clearance of NeuMoDx CT/NG Assay for use on both NeuMoDx 96 and 288 Molecular Systems
January 08 2024 - 2:00AM
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
the U.S. Food and Drug Administration (FDA) clearance for the
NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated
PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in
the United States.
This assay is designed for direct detection of
asymptomatic and symptomatic bacterial infections involving
Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG) –
the most common type of bacterial infection among sexually
transmitted infections (STIs), according to the U.S. National
Institutes of Health. The majority of these infections are
asymptomatic and generally curable with existing single-dose
regimens of antibiotics. However, the time it takes for results to
be received is often long, impeding follow-up care.
This FDA clearance supports the test menu
expansion for NeuMoDx Molecular Systems in the U.S. It also builds
on the 16 EU-certified in-vitro diagnostics (CE-IVD) tests
available on these systems, which is one of the broadest on the
market in countries accepting CE-IVD markings, including assays for
transplant-associated viruses, respiratory infections, blood-borne
viruses, and sexual and reproductive health.
“Ensuring rapid and accurate diagnosis of STIs
is an important medical need that QIAGEN is helping to address with
the clearance of this NeuMoDx assay in the U.S.,” said Fernando
Beils, Senior Vice President, Head of the Molecular Diagnostics
Business Area at QIAGEN. “It also marks an important milestone with
the first FDA clearance of a NeuMoDx assay for use on both systems,
and this will be an important differentiator in building out the
menu in the U.S. to complement the broad menu offered in Europe and
other countries.”
The NeuMoDx 96 and 288 Molecular Systems are
fully automated, continuous random-access analysers that deliver
results in just about an hour. The systems extract DNA to isolate
the target nucleic acids and then conduct a real-time polymerase
chain reaction (RT-PCR). Room-temperature stable reagents and
consumables dramatically reduce waste. Based on microfluidic
cartridges, they allow running of 12 reactions at once and up to
eight hours of operator walkaway capability. These capabilities
dramatically improve lab productivity and the ability to provide
clinicians with critical information in a timely manner.
For more information about the NeuMoDx assay
menu, please visit
https://go.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
September 30, 2023, QIAGEN employed more than 6,000 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, including those
products used in the response to the COVID-19 pandemic, 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, including the
breadth and duration of the COVID-19 pandemic 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
Phoebe Loh
QIAGEN N.V.
+49 2103 29 11457
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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