QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast & Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Ant...
May 12 2021 - 4:05PM
Business Wire
- U.S. authorization gives healthcare professionals access to
portable rapid testing device that can monitor immune status in
relation to COVID-19
- Test based on QIAGEN partner Ellume’s proprietary eHub
technology and helps ease testing shortfalls by using automation
and providing easy-to-read results
- eHub digital device can handle eight tests at once, all working
independently of each other, can process up to 32 samples per hour,
can eventually be used simultaneously with the antigen test
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced it has received Emergency Use Authorization (EUA) from
the U.S. Food and Drug Administration (FDA) for the fast and
easy-to-use QIAreach® Anti-SARS-CoV-2 Total Test.
The authorization means QIAGEN can start making its portable
antibody testing device available to health-care professionals in
the U.S. Each antibody test takes only about 10 minutes to identify
whether a person carries antibodies to the SARS-CoV-2 virus as a
result of prior infection. Individual test results are read on a
digital eHub device that can process up to 32 tests per hour – and
will eventually also run the antigen test.
The QIAreach Anti-SARS-CoV-2 Total Test is a serological test
that has been shown to have a sensitivity of 93.85% (CI
84.99–98.30%) and a specificity of 97.83 %–%% (CI 95.00–99.29%).
QIAGEN’s technology detects total antibodies (Total immunoglobulin)
specific to SARS-CoV-2 immune response – while most other tests
currently identify only selected antibodies.
The QIAreach Anti-SARS-CoV-2 Total Test was developed in
partnership with Ellume, an Australian digital diagnostics company.
It is the first of two QIAGEN COVID-19 tests to make use of
Ellume’s digital eHub and eStick system: QIAGEN in early September
2020 presented the QIAreach SARS-CoV-2 Antigen Test to detect
active SARS-CoV-2 infection, which has been submitted to the FDA
for an EUA.
Research into the SARS-CoV-2 pandemic also requires the
monitoring of the immune status of individuals. QIAGEN is the only
company that has developed both an antibody and a T-cell test to
track immune responses. In November, it also launched the
QuantiFERON SARS-CoV-2 test (for research use only) that can detect
T-cell responses in people who have had natural infection or
vaccination.
“Serological testing for antibodies is central to identifying
people who have been recently infected by the virus or have been
infected in the recent past, especially those who did not show any
symptoms and therefore might not know of an infection,” said Davide
Manissero, Chief Medical Officer of QIAGEN. “As societies are now
returning to normal daily routines, understanding the COVID-19
immunity in a population can help guide public health
measures.”
Traditional rapid lateral-flow antibody tests are hard to
automate and results can be hard to read. The QIAreach
Anti-SARS-CoV-2 Total Test generates easy-to-read results on the
digital eHub platform. Each QIAreach eHub can handle up to eight
samples on eight eSticks simultaneously, with each eStick test
running independently. QIAGEN is using the same platform to develop
QIAreach® QuantiFERON®-TB, a new testing solution for identifying
latent tuberculosis (TB) infections in low-resource regions.
Further information on QIAGEN’s response to the coronavirus
outbreak can be found here.
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, 2020, 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.
Category: Corporate
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version on businesswire.com: https://www.businesswire.com/news/home/20210512005959/en/
QIAGEN Investor Relations John Gilardi, +49 2103
29 11711 Phoebe Loh, +49 2103 29 11457 ir@QIAGEN.com
Public Relations Thomas Theuringer, +49 2103 29 11826
Robert Reitze, +49 2103 29 11676 pr@QIAGEN.com
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