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PlexBio Secures Multi-Regional Regulatory Approvals for Automated Sample Prep SystemJan 09, 2026

PlexBio (博錸) has achieved significant regulatory milestones for its IntelliPrep TRIO 240, a fully automated sample preparation system. Within the past year, the system has secured US FDA listing, South Korean MFDS approval, and the latest EU CE-IVDR certification.

Clinical and Technical Edge:

  • Integrated Workflow: The TRIO 240 automates four critical steps: nucleic acid extraction, quantification, normalization, and PCR setup.
  • Sample Versatility: Optimized for challenging clinical samples, including FFPE (tissue biopsy), plasma, and whole blood.
  • Downstream Compatibility: Seamlessly connects to qPCR, dPCR, and NGS platforms for oncology, infectious disease, and genetic testing.
  • Market Deployment: Units are already operational in Taiwanese national hospitals and have been shipped to partners in Spain (Akralab), France, and Switzerland to support clinical molecular diagnostics.

Resource: 博錸全自動檢體製備系統陸續取得美韓歐法規認證