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.
Looking ahead, this achievement lays the foundation for Fulgent Genetics’ long-term growth strategy in global markets. By meeting Europe’s stringent regulatory standards, Fulgent not only strengthens its reputation as a leader in molecular diagnostics but also increases its ability to support precision medicine initiatives across diverse healthcare systems. As demand continues to grow for robust genomic tools capable of diagnosing rare and undiagnosed genetic conditions, FulgentExome is poised to deliver meaningful improvements in patient outcomes, while driving scalable solutions that can be adapted to evolving clinical and regulatory environments worldwide.
MedTech Spectrum's Summary
CE Mark Expands Global Reach: Fulgent Genetics has received CE certification under the EU's IVDR for its FulgentExome and Fulgent Pipeline Manager (PLM), enabling clinical use across Europe and positioning the company for broader international market penetration.
Comprehensive and Clinically Focused: With validation for over 4,600 genes, FulgentExome provides a high-quality, phenotype-driven NGS platform that supports accurate diagnosis of hereditary conditions, offering both depth and clinical relevance in genomic testing.
Strengthens Precision Medicine Infrastructure: This regulatory milestone reinforces Fulgent's role in advancing precision diagnostics globally, opening pathways for clinical trial integration, public health reimbursement, and future innovation in personalized healthcare.
