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Validating Whole Genome Nanopore Sequencing, using Usutu Virus as an Example

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Closing the implementation gap: a harmonised EU framework for synthetic nucleic acid screening and customer

Sophie Peresson¹, Patrick Stadler²

¹Independent Consultant, Paris, France.

Frontiers in Bioengineering and Biotechnology

|July 16, 2026

Summary

New EU biosecurity regulations are proposed to address dual-use risks from synthetic nucleic acid technologies. The framework uses Know Your Customer (KYC) and Sequences of Concern (SOC) screening to close gaps in current voluntary measures.

Keywords:

biosecurity know your customer (KYC) verification regulation sequence screening sequences of concern (SOC)

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Area of Science:

Synthetic biology
Biosecurity
Molecular biology

Background:

Synthetic nucleic acid technologies are crucial for research and biomanufacturing.
Increased accessibility of these technologies presents significant dual-use biosecurity risks.
Current voluntary biosecurity frameworks have systematic coverage gaps.

Purpose of the Study:

To present a harmonized EU biosecurity screening framework.
To evaluate Know Your Customer (KYC) verification and sequence screening against Sequences of Concern (SOC) as control mechanisms.
To advocate for binding EU-level obligations to enhance biosecurity.

Main Methods:

Analysis of existing voluntary biosecurity frameworks.
Evaluation of KYC verification and SOC screening.
Assessment of proposed EU Biotech Act I and ISO 20688-2:2024 standards.

Main Results:

Existing voluntary frameworks are insufficient, leaving coverage gaps.
Binding EU obligations, anchored to ISO 20688-2:2024, would address these gaps.
The proposed framework is particularly relevant for smaller providers and benchtop devices.

Conclusions:

Near-term EU action is critical to shape global synthetic biology governance.
Harmonized biosecurity screening is essential to mitigate dual-use risks.
Proactive regulatory measures can prevent future regulatory fragmentation.