, potentially making it the first such system with this level of diagnostic coverage to gain approval under the stringent framework.){kind=link}
A NGS platform developed by Fulgent Genetics has received CE certification under the European Union’s In Vitro Diagnostic Regulation (IVDR), potentially making it the first such system with this level of diagnostic coverage to gain approval under the stringent framework.
The certification applies to FulgentExome, a clinical exome test covering over 4,600 genes and its associated software, the Fulgent Pipeline Manager (PLM), which together form a comprehensive system for the detection and analysis of germline variants. The company claims the system offers one of the most extensive end-to-end solutions currently available for clinical diagnostics of hereditary disorders.
FulgentExome is designed for phenotype-driven analysis of coding regions and splice junctions in genes relevant to suspected inherited diseases. It uses NGS to identify variants of potential clinical significance and reports findings tailored to the patient’s symptoms and family history. The PLM software component processes sequencing data, facilitating variant interpretation in line with IVDR requirements.
The CE certification, issued by the German notified body TÜV SÜD, allows the test to be marketed across the European Economic Area. Under IVDR a regulation that came into force in 2022 and imposes more rigorous demands for analytical and clinical validation of in vitro diagnostic devices, only a small fraction of genetic testing platforms have so far gained approval.
The European designation may also open avenues for clinical trial inclusion and reimbursement in national healthcare systems. However, adoption of IVDR-compliant tests remains uneven across EU member states, and broader implementation could hinge on local clinical utility assessments and payer policies.