Fulgent Genetics Inc. has announced that it has received CE certification from TÜV SÜD under the European Union's In Vitro Diagnostic Regulation $(EU)$ 2017/746 for its germline next-generation sequencing $(NGS)$ system, which includes FulgentExome and Fulgent Pipeline Manager $(PLM)$. This certification marks a significant achievement for Fulgent Genetics, allowing the company to offer its comprehensive end-to-end germline testing services, which cover over 4600 genes, to clinics and hospitals across Europe. This development is expected to aid in the clinical diagnosis of hereditary diseases and support clinical trials, potentially facilitating reimbursement pathways under the IVDR.
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