QIAGEN receives European IVDR certification for QIAGEN Clinical Insight Interpret, its medical device software for clinical decision support
14 Mai 2024 - 10:05PM
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
an updated version of its clinical decision support platform,
QIAGEN Clinical Insight Interpret for NGS molecular profiling of
hereditary and somatic diseases, has received the European Union
(EU) Technical Documentation Assessment and Quality Management
System certificate under the European In Vitro Diagnostic Medical
Device Regulation (EU) 2017/746 (IVDR).
QIAGEN Clinical Insight Interpret is the first
NGS interpretation platform to be certified under IVDR for both
oncology and hereditary applications. As a medical device software
for clinical decision support (Class C IVD Medical Device) it
conforms with regulatory policy, ensuring greater patient
protection, information transparency, and data traceability. The
updated certified version will be available for customers in Europe
later in 2024, depending on requirements for sale in respective
countries.
“Receiving IVDR certification for QIAGEN
Clinical Insight Interpret is further confirmation that our
clinical customers benefit from a high-quality and regulatory
compliant software that allows scaling and acceleration of critical
turn-around times and workflow efficiencies,” said Jonathan
Sheldon, Senior Vice President of QIAGEN Digital Insights. ”Our
Augmented Molecular Intelligence approach to content curation and
analysis that has been leveraging humans as well as Artificial
Intelligence (AI) and Machine Learning for over 20 years delivers
highly accurate and repeatable interpretation essential for
clinical decision support.”
QIAGEN Clinical Insight Interpret is a universal
solution for tertiary analysis that can be used with any validated
panel and sequencing platform. It provides variant annotation,
classification, interpretation and reporting of somatic and
germline next-generation sequencing (NGS) tests. With over 4
million NGS patient test cases analyzed and interpreted worldwide,
it is one of the most widely used and universally respected
platforms for efficiently accessing clinical evidence to support
confident decision-making in genetic testing.
QIAGEN Redwood City, the development site of the
QIAGEN Clinical Insight Interpret platform, has ISO 13485:2016
certification for its Medical Devices and Quality Management
Systems based on the QIAGEN Clinical Insight Interpret product. ISO
13485:2016 is an internationally recognized quality standard to
ensure the consistent design, development, production, installation
and sale of medical devices that are safe for their intended
purposes. To be certified, organizations must demonstrate an
ability to provide medical devices and related services that
consistently meet customer and regulatory requirements.
More information about QIAGEN Clinical Insight
Interpret can be found at
https://digitalinsights.qiagen.com/products-overview/clinical-insights-portfolio/qiagen-clinical-insight/qci-interpret/.
Learn more about QIAGEN’s IVDR-certified
solutions on QIAGEN's IVDR support site.
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, 2024, QIAGEN employed more than 5,900 people in over
35 locations worldwide. Further information can be found at
http://www.qiagen.com.
About QIAGEN Digital Insights
QIAGEN Digital Insights, the bioinformatics
business of QIAGEN, is the leading provider of genomic and clinical
knowledge, analysis and interpretation tools and services for
scientists and clinicians. We have over 25 years of experience in
the industry, 90,000 users worldwide, over 100,000 citations in
scientific papers, more than 3.5 million profiled patient cases and
over 40 billion scientific data points. Discover our portfolio of
expertly curated genomic and clinical knowledge solutions as well
as bioinformatics software and services for efficient data
management, sharing and actionable insights. Learn more
at https://digitalinsights.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
John Gilardi
QIAGEN N.V.
+49 2103 29 11711
ir@qiagen.com
Domenica Martorana
QIAGEN N.V.
+49 2103 29 11244
ir@qiagen.com
Thomas Theuringer
QIAGEN N.V.
+49 2103 29 11826
pr@qiagen.com
Daniela Berheide
QIAGEN N.V.
+49 2103 29 11676
pr@qiagen.com
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