QIAGEN Highlights Profile of New QIAstat-Dx Meningitis / Encephalitis pAnel Focused on Most Prevalent Central Nervous System Pathogens
New data presented at ECCMID 2019 ahead of planned H2 2019 CE-IVD
launch of panel, addition to current respiratory and gastrointestinal
panels for use on syndromic testing platform
HILDEN, Germany & AMSTERDAM–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24QGEN&src=ctag” target=”_blank”gt;$QGENlt;/agt;–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
new data of the QIAstat-Dx Meningitis / Encephalitis panel. The panel is
in late stage development and being prepared for CE-IVD
commercialization in the second half of 2019 for use on the QIAstat-Dx
multiplex syndromic testing system. The preliminary data demonstrates
effective detection of the most prevalent central nervous system
pathogens with high analytical sensitivity and specificity levels,
including the discrimination of clinically relevant strains and subtypes.
This new test will expand the QIAGEN menu of diagnostic panels for
syndromic testing, adding to CE-IVD marked DiagCORE tests for
respiratory and gastrointestinal infections that were launched in 2018.
The U.S. regulatory clearance of QIAstat-Dx is expected in mid-2019, and
a deep menu of additional tests covering infectious diseases and other
therapeutic areas is in development.
The planned QIAstat-Dx Meningitis / Encephalitis panel in Europe is
designed to enable one-step, fully integrated molecular diagnosis of
meningitis (inflammation of the membrane surrounding the brain and
spinal cord) or encephalitis (inflammation of the brain itself)
conditions. The QIAstat-Dx panel will provide actionable insights in
about one hour, analyzing more than 20 pathogens that cause meningitis /
encephalitis syndromes, including bacteria, viruses and yeast and
provides information on Ct values as well as amplification curves – some
of the many features QIAstat-Dx boasts that no other syndromic system
“Our new QIAstat-Dx panel meets an urgent need for rapid and reliable
diagnosis of meningitis and encephalitis infections, and will enable
clinicians to select appropriate therapies in a timely manner. The panel
delivers valuable insights with high sensitivity and specificity to
identify these life-threatening syndromes,” said Thierry Bernard, Senior
Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area.
“Laboratories in Europe are embracing the new platform and the power of
syndromic testing based on proven PCR technologies to identify syndromic
conditions with the simplicity of a true Sample to Insight solution.
Demand for syndromic testing is growing rapidly, and we are developing a
deep menu of assays to significantly increase the utility of QIAstat-Dx
for an increasing range of applications.”
The data presented at the 29th European Congress of Clinical
Microbiology & Infectious Diseases (ECCMID 2019), taking place April
13-16 in Amsterdam, Netherlands, showed the QIAstat-Dx Meningitis /
Encephalitis panel offered combined automated sample preparation,
amplification, detection and analysis in one step for molecular analysis
of more than 20 pathogens. These included targets for Neisseria
meningitidis (meningococcal strains including serotypes A, B, C, D,
W, X, Y), Streptococcus pneumoniae, Streptococcus agalactiae
(Group B Streptococcus), Listeria monocytogenes and all
relevant Haemophilus influenzae subtypes.
An estimated 2.8 million cases of meningitis occurred globally in 2016,
the most recent year for which data are available, according to a World
Health Organization (WHO) report in February 2019. While deaths due to
meningitis have declined in recent years, the disease still took an
estimated 290,000 lives in 2015. Among survivors, meningitis can lead to
brain damage, hearing loss or other permanent disabilities.
The QIAstat-Dx system’s key advantages include:
- Powerful technology capabilities: Using QIAGEN sample and assay
technologies, the system can deliver true Sample to Insight processing
of even the most challenging samples, opening up opportunities in a
broad range of application areas not possible with currently available
systems. Samples include tissue samples in pathology, liquid or
difficult-to-handle sputum samples in infectious disease, with direct
onboard swab processing.
- Multi-analyte capabilities: The system is the only multiplex
syndromic testing system based on real-time PCR (polymerase chain
reaction) technology that can process up to 48 targets, and is
designed with the additional capability to process immuno-assays.
These features create unmatched target and application versatility, as
well as disease management options.
- Integration of real-time PCR technology: This system enables
customers to precisely quantify biological targets, which is
specifically important in oncology or transplantation patients and
leads to improved treatment decisions. The use of real-time PCR also
allows a vast portfolio of current real-time PCR tests to be portable
onto the system. The value of Ct values is currently in validation.
- Flexible approach to results: The proprietary workflow design
with an attractive cost of ownership has the potential to enable
laboratories to take a tailored approach to the selective analysis and
reporting of tested molecular targets. The flexible approach will
represent a significant improvement over currently available systems
that offer rigid panel designs, and therefore require co-processing of
molecular targets found to be irrelevant in the patient sample, which
may complicate reimbursement.
For more information, please visit http://www.qiagen.com/ie/shop/detection-solutions/qiastat-dx.
QIAGEN at ECCMID 2019
Initial data on the QIAstat-Dx Meningitis Panel is presented at the
conference, as well as over 30 other abstracts and presentations
featuring QIAGEN products. For QIAstat-Dx alone, several highlights
- Specificity analysis of the new QIAstat-Dx meningitis/encephalitis
panel focused on the most prevalent central nervous system pathogens –
- Evaluation of the QIAstat-Dx system for the detection of enteric
pathogens – #P1531
- External control samples for verification of the QIAstat-Dx
Respiratory Panel in the clinical care setting – #P1557
Exhibition booth No. 1.20 at ECCMID will feature demonstrations of
QIAGEN’s Sample to Insight solutions for infectious diseases, including
workflow for the QIAstat-Dx, NeuMoDx 288 and 96, and QIAsymphony
automation systems. To learn more about QIAGEN’s presence at ECCMID,
please visit http://eccmid.qiagen.com
or follow the Twitter handle @QIAGEN
during the conference.
Additionally, QIAGEN will host a symposium, “Diagnosis is in the details
– how to improve patient outcomes in multiple clinical settings with
rapid, easy-to-use syndromic testing utilizing real-time PCR and Ct
values.,” at 4:00 p.m. Monday April 15 in Hall M – Forum Auditorium.
Speakers include Dr. Glen Hansen of the University of Minnesota, Dr.
Jordi Vila of Barcelona Hospital, Dr. Carmen Muñoz-Almagro of Barcelona
Hospital Sant Joan de Déu, and Tanja Rockenbach of London’s Great Ormond
Street Hospital for Children.
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, 2018, QIAGEN employed about 5,000 people in over 35 locations
worldwide. Further information can be found at http://www.qiagen.com.
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, launches,
regulatory submissions, collaborations, markets, strategy, taxes or
operating results, including without limitation its expected sales,
adjusted net sales and adjusted diluted earnings per share 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; 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 (SEC).
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