QIAGEN reaffirms effectiveness of its SARS-CoV-2 PCR tests in light of the new coronavirus variant B.1.1.529
27 November 2021 - 1:18AM
Business Wire
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced its polymerase chain reaction (PCR) tests remain accurate
and effective in detecting SARS-CoV-2 infections in light of the
emergence of a new variant of concern detected in South Africa.
QIAGEN has successfully assessed its SARS-CoV-2 PCR tests
against the genetic mutations of the variant, which is known by its
scientific name, B.1.1.529. The assessment was made against data
available in the GISAID and GenBank public databases.
This applies to all of QIAGEN’s PCR tests for detection of the
SARS-CoV-2 virus involving:
- artus SARS-CoV-2 Prep&Amp UM Kit, a CE-marked
SARS-CoV-2 test that integrates sample preparation and detection in
a single kit, enabling throughput of more than 670 tests per PCR
cycler in an eight-hour shift
- QIAstat-Dx syndromic testing system, which includes the
CE-marked test QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2
to quickly identify in about an hour whether patients have common
seasonal respiratory infections or SARS-CoV-2. QIAGEN also offers
the offers the QIAstat-Dx Respiratory+ test in the U.S., Europe and
other markets for detection of more than 20 respiratory illnesses,
including COVID-19 infections.
- NeuMoDx 96 and 288 integrated PCR testing systems used
in laboratory testing. QIAGEN offers tests worldwide for use on
this system for detection of the SARS-CoV-2 virus. In the U.S., the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 VantageAssay is available for use in
testing patients with suspect infections.
Furthermore, the new variant is reliably detected by:
- QIAGEN’s QIAcuity digital PCR solution, which uses a
SARS-CoV-2 wastewater surveillance assay developed in collaboration
with GT Molecular, Inc.
- QIAGEN’s QIAprep& Viral RNA kit, which uses qPCR
genotyping assays that are available in collaboration with
biomers.net.
QIAGEN has been closely monitoring – and will continue to do so
– the performance of its PCR tests as new variants emerge in the
global fight against the coronavirus pandemic. Surveillance of
genetic variations will continue on a biweekly basis.
“The best way to fight the global COVID-19 pandemic is a
combination of extensive vaccinations, rigorous testing with
gold-standard PCR tests, aggressive surveillance of new variants
and above all compassionate treatment for those infected with the
SARS-CoV-2 virus,” said Dr. Davide Manissero, M.D., Chief Medical
Officer of QIAGEN N.V.
“We are pleased to report that the emergence of this new variant
of concerns, as has been the case with other variants, has had no
impact on the effectiveness of our SARS-CoV-2 PCR tests. Further
genomic sequencing of SARS-CoV-2 samples worldwide will vastly
increase transparency and help us identify and respond to
potentially dangerous mutations of the virus, while at the same
time broadening the database we can use to verify if vaccines and
tests continue to be effective,” Manissero said.
The new variant of concern joins a list of other variants with
potentially increased transmissibility. These include the Alpha
variant (B.1.1.7, first detected in the United Kingdom), the Beta
variant (B.1.351, identified in South Africa), and the Gamma
variant (B.1.1.28 P1, detected in Brazil). As a virus encoded by
RNA nucleotides, SARS-CoV-2 frequently mutates due to erroneous or
ineffective replication of the virus genome. These mutations can
sometimes produce viruses with altered properties or even entirely
new strains.
To better identify and differentiate potentially dangerous
variants, countries around the world are increasing the frequency
of sequencing positive SARS-CoV-2 samples to monitor the occurrence
of potential mutations.
To support these initiatives, QIAGEN offers the QIAseq DIRECT
SARS-CoV-2 solution for rapid and comprehensive monitoring of
sequence drift of the virus around the world, as well as QIAGEN
Digital Insights bioinformatic analysis solutions.
QIAGEN publicly reports the outcome of the products surveillance
against emerging variants and genomic databases on a two-weekly
basis. The results are available at:
www.qiagen.com/us/applications/infectious-disease/coronavirus/
Additional information regarding QIAGEN’s efforts against
SARS-CoV-2 can be found at www.qiagen.com.
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),
Applied Testing (primarily forensics), Pharma (pharma and biotech
companies) and Academia (life sciences research). As of September
30, 2021, QIAGEN employed approximately 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, 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).
###
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 e-mail:
pr@QIAGEN.com
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