QIAGEN receives European IVDR certification for QIAGEN Clinical Insight Interpret, its medical device software for clinical decision support

As the first NGS interpretation platform for both oncology and hereditary applications, the updated version of QIAGEN Clinical Insight Interpret is approved for diagnostic use // Regulatory framework ensures greater patient protection, transparency of information, and traceability of data // Over 4 million NGS patient test cases for oncology and hereditary diseases worldwide processed with QIAGEN Clinical Insight Interpret

Venlo, the Netherlands, May 14, 2024 (GLOBE NEWSWIRE) -- 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

CONTACT: 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