QIAGEN expands QIAstat-Dx syndromic testing menu and announces launch plans for new QIAstat-Dx Rise higher-throughput version
January 10 2022 - 9:12AM
Business Wire
- New tests for QIAstat-Dx syndromic solution to distinguish
between gastrointestinal pathogens (U.S. submission) and between
meningitis and encephalitis infections (CE-IVD registration)
- Higher-capacity QIAstat-Dx Rise platform set for CE-IVD launch
in mid-2022, provides new option to enable labs and hospitals to
increase testing volumes with enhanced walk-away efficiency through
unique QIAstat-Dx Rise Smart drawer to automate processing
- QIAstat-Dx cartridges designed for use on expanded series of
QIAstat-Dx options offering random access to process one, four or
eight tests simultaneously
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced important enhancements in the commercialization of its
QIAstat-Dx syndromic testing solution – which enables laboratories
and hospitals worldwide to test patients for multiple pathogens
from one sample – with new tests and the launch of a
higher-throughput version that includes a new level of walk-away
efficiency through the new QIAstat-Dx Smart Drawer.
The test enhancements for QIAstat-Dx, a fully integrated
molecular diagnostic testing solution with one-step sample
processing that provides results in about one hour, involve:
- The submission of a Gastrointestinal (GI) panel for U.S.
regulatory approval designed to detect 22 common viral, bacterial
and parasitic pathogens that can cause potentially life-threatening
infections. QIAGEN launched a first version of this multiplex test
in Europe in 2019 and is planning to submit an updated version for
IVDR review and approval in 2022.
- The CE-registration of a Meningitis / Encephalitis panel in
Europe designed to detect 15 different pathogens and help to
distinguish between meningitis (inflammation of the membrane
surrounding the brain and spinal cord) and encephalitis
(inflammation within the brain). The test analyzes 15 pathogens
simultaneously and enables clinicians to undertake a one-step,
fully integrated molecular diagnosis of either condition in about
one hour.
The new panels build on the successful uptake of two different
respiratory tests designed for use on QIAstat-Dx, which is
available worldwide. The QIAstat-Dx Respiratory+ test can detect 22
different respiratory pathogens, including the SARS-CoV-2 virus
(including Delta and Omicron variants of interest), while the
QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test is a
so-called four-plex test designed for detection of the coronavirus
as well as influenzas A or B, and respiratory syncytial virus
(RSV).
“The expansion of the test menu will increase the utility of
QIAstat-Dx for customers around the world, and build on the urgent
medical needs created with COVID-19 that continues demonstrate the
relevance and value of syndromic testing,” said Jean Pascal Viola,
Senior Vice President and Head of the Molecular Diagnostics
Business Area at QIAGEN. “Complementing the menu expansion is the
introduction of QIAstat-Dx Rise as a new option for our customers
to handle the increasing demand for rapid test results.”
Building on the currently available QIAstat-Dx Analyzer with one
to four analytical modules, and both systems using the same test
cartridges, QIAstat-Dx Rise is planned to be made available with
the European CE marking to customers in the middle of 2022. The
submission for U.S. regulatory approval is planned for the end of
2022.
QIAstat-Dx Rise has random access capacity to hold up to 18
different tests for processing, and leading to up to 56 tests in an
eight-hour shift and 160 tests per day with eight analytical
modules.
This new version will enable customers to raise testing
efficiency and their “walk-away” time with the new QIAstat-Dx Smart
Drawer. This feature automatically detects sample types for the
QIAstat-Dx panels, provides digital cartridges traceability and
prioritization, and enables immediate urgent testing. With a
footprint less than 60 cm, the system also requires minimal lab
space and can be placed as a stand-alone device on any lab
bench.
For more information, please visit:
https://www.qiagen.com/de/applications/syndromic-testing
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 December
31, 2021, 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, 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 Source: QIAGEN N.V.
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Contacts 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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