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Qiagen Gets IVDR Certification for Clinical Insight Interpret Software

NEW YORK – Qiagen announced Tuesday that it has obtained European In Vitro Diagnostic Medical Device Regulation (IVDR) certification for its Clinical Insight Interpret software.

Clinical Insight Interpret is a universal solution for tertiary analysis. It can be used with any validated panel and sequencing platform for variant annotation, classification, interpretation, and reporting of somatic and germline next-generation sequencing tests, Qiagen said in a statement.

The software enables NGS molecular profiling for both oncology and hereditary diseases, Qiagen also said, and the updated version is approved for diagnostic use.

"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 turnaround times and workflow efficiencies," Jonathan Sheldon, senior VP of Qiagen Digital Insights, said in a statement.

The Clinical Insight software was first released in 2015. Qiagen subsequently acquired N-of-One to incorporate that firm's oncology decision support tools, expanded access through partnerships, and recently also added artificial intelligence capabilities and secondary analysis software.

Clinical Insight Interpret is now the first NGS interpretation platform to be certified under IVDR for both oncology and hereditary disease applications, Qiagen said, noting that more than 4 million NGS patient test cases have been processed with the software to date.