Fulgent Genetics’ recent CE certification under the European Union’s In Vitro Diagnostic Regulation (IVDR) marks a pivotal moment in the company’s expansion into the European clinical genomics market. The approval covers its FulgentExome germline next-generation sequencing (NGS) platform and the associated Fulgent Pipeline Manager (PLM) software. This end-to-end diagnostic solution has been validated for over 4,600 genes and represents one of the most comprehensive CE-marked offerings for hereditary disease diagnostics currently available. The system is designed to analyze coding regions and splice junctions, providing physicians with focused insights into clinically significant variants based on a patient’s phenotype and medical history.

This regulatory milestone underscores Fulgent’s innovation in delivering patient-centric, high-throughput genomic solutions that balance clinical accuracy with efficiency. FulgentExome combines advanced sequencing technology with intelligent software integration through PLM to support diagnostic clarity in complex cases. With CE certification from TÜV SÜD, Fulgent now has the ability to offer these tools across hospitals, clinics, and public health programs in Europe, enabling healthcare providers to offer high-quality hereditary testing with fast turnaround times. In addition, the platform’s regulatory compliance may support broader access to reimbursement pathways and clinical trial inclusion, enhancing both clinical care and research opportunities.