QIAGEN’s NeuMoDx™ HAdV Quant Assay Secures CE-IVD Certification for Automated Testing to Detect Human Adenovirus Infections
July 08 2021 - 4:22PM
Business Wire
- Important expansion of menu for NeuMoDx™ 96 and 288 Molecular
Systems marks the 15th assay with a CE-IVD marking, one of the
largest menus available for integrated PCR testing
- Driving greater utilization of non-COVID-19 tests in Europe,
U.S. and other markets
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced that its NeuMoDx™ HAdV Quant Assay for the identification
and quantification of human adenovirus (HAdV) DNA has received
CE-IVD certification for the European Union and other countries
that accept this marking.
This milestone marks the 15th assay available on the NeuMoDx™ 96
and 288 Molecular Systems, which is considered one of the broadest
menus available among competitors. The tests can be run in true
random access along with Laboratory Developed Tests (LDTs).
Additional assays planned for CE-IVD launch in 2021 include Herpes
Simplex Virus (HSV I/II), Human Herpesvirus 6 (HHV-6) as well as an
FDA submission for Chlamydia & Gonorrhea (CT/NG).
Testing for the human adenovirus is critical since it can cause
severe respiratory and other diseases in patients with weakened
immune systems, a common consequence of organ transplantation.
The new HAdV Quant Assay was developed in partnership with
Sentinel Diagnostics, an IVD company engaged in the development and
production of diagnostic kits for Clinical Chemistry,
Immunochemistry and Molecular Diagnostics. The availability of the
HAdV assay strengthens the current NeuMoDx transplant assay menu
that already includes CE-marked tests for cytomegalovirus (CMV),
Epstein–Barr virus (EBV) and BK Virus (BKV) viral load monitoring
for the management of immunocompromised patients, such as those who
have undergone organ transplantation.
All of these assays make use of QIAGEN’s automated, three-step
NeuMoDx solutions that extract DNA from blood or urine to isolate
the target nucleic acids and then conduct a real-time polymerase
chain reaction (RT-PCR) to target conserved sequences in the HAdV
genome.
The NeuMoDx solutions currently offer CE-IVD tests for various
viral and bacterial pathogens. Aside from assays for respiratory
infections from SARS-CoV-2 to the 4-Plex test for Influenza A and
B, RSV and SARS-CoV-2 covering the most common respiratory
pathogens, there are tests for blood-borne viruses and
post-transplant monitoring for CMV, EBV and BKV. The menu also
features assays covering sexual and reproductive health including
HPV and Chlamydia trachomatis.
Learn more about the NeuMoDx™ HAdV Quant Assay at
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 March 31, 2021, QIAGEN
employed approximately 5,700 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
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QIAGEN
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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