April 11, 2023
Redwood City, California, April 11, 2023 – QIAGEN Digital Insights, the bioinformatics division of QIAGEN, today announced it is progressing towards its goal of getting its clinical decision support platform, QIAGEN Clinical Insights Interpret (QCI Interpret), certified under the new In Vitro Diagnostic Regulation (IVDR). QIAGEN Redwood City, the development site of the QCI Interpret platform, has successfully received ISO 13485:2016 certification for its Medical Devices and Quality Management Systems based on the QCI Interpret product. The company is awaiting approval of QCI Interpret as an IVDR medical device under the current regulation (EU) 2017/746 based on formal submission of the technical documentation.
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. The IVDR (EU) 2017/746 is a harmonized regulatory framework to ensure present and future safety and performance of in vitro diagnostic (IVD) medical devices in the European Union market.
“The implementation of ISO 13485:2016 is the best internationally recognized model to help demonstrate that QIAGEN Digital Insights has successfully complied to the laws and regulations of the medical devices industry,” said Davide Manissero, Chief Medical Officer, QIAGEN. “We are very pleased to have our ISO 13485 certification for QCI Interpret and are now awaiting approval for IVDR certification. These steps represent an important milestone for our company and demonstrate our commitment to develop QCI Interpret in compliance with the highest standards for safety, transparency, product performance and reliability.”
QCI Interpret is a clinical decision support software platform that facilitates the classification and prioritization of genetic variants utilizing QIAGEN’s unparalleled knowledge base of curated scientific literature and information. The system combines standardized human processes with augmented intelligence to maximize the scalability and accuracy of the software. QCI Interpret accesses content that has been identified, analyzed, and processed into computable units by a large team of MD and PhD scientists and executes rules based on the ACMG and AMP guidelines for pathogenicity and actionability to derive disease-specific classifications for each variant that are presented for review. The software then generates patient-specific reports with the latest diagnostic and prognostic information, as well as biomarker-directed therapies and clinical trials.
“Acquiring ISO 13485:2016 and receiving IVDR certification is not only invaluable to our customers and future customers in Europe, but also the rest of the world,” said Jonathan Sheldon, Executive Vice President of QIAGEN Digital Insights. “Today we have six datacenters worldwide processing over 800,000 patient cases and reports a year. Our leadership position is driven by quality content and applications that people can trust. Having the additional IVDR certification provides even greater confidence that QIAGEN Digital Insights follows best practices to deliver compliant, secure and sustainable products that our customers can rely on.”
Learn more about the QCI portfolio here.
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 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/.
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 March 31, 2023, QIAGEN employed more than 6,000 people in over 35 locations worldwide. Further information can be found at https://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, 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).