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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.



Learn more about QIAGEN’s IVDR-certified solutions on QIAGEN's IVDR support site.



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