QIAGEN 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. 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.