SecureDNA and the OSTP Framework

Ensure OSTP Framework compliance with SecureDNA's advanced nucleic acid screening platform.

The Office of Science and Technology Policy (OSTP) has released a Framework for Nucleic Acid Synthesis Screening, outlining six key actions for providers and manufacturers of synthetic nucleic acids and related equipment. SecureDNA's advanced features and capabilities significantly aid users in complying with these requirements. This page aims to detail how SecureDNA addresses each of the six key actions.

  • 1. Attestation of Framework Implementation

    The White House is expected to develop its own sample attestation form but does not yet provide specific attestation language.

    How SecureDNA Helps:

    SecureDNA recommends those required to display an attestation on their website to use the template produced by the Johns Hopkins Center for Health Security:

    “[Company name] understands that United States federally funded life sciences entities and funding agencies are relying on this attestation prior to purchasing gene synthesis equipment or gene synthesis products. [Company name] self-attests to complying with the US Framework for Nucleic Acid Synthesis Screening. Should this information change, [Company name] agrees that it will update this statement.”

  • 2. Screening for Sequences of Concern (SOCs)

    The Framework requires providers to screen all purchase orders for SOCs, initially defined as sequences matching regulated agents (BSAT, CCL), with screening covering every 200-nucleotide window, decreasing to 50 nucleotides by October 2026.

    How SecureDNA Excels:

    • SecureDNA's screening capabilities already exceed the 2026 requirements, screening sequences below the 50bp length.

    • The platform uses a "random adversarial threshold" (RAT) search algorithm, effectively identifying matches to short hazardous DNA and peptide subsequences, including millions of predicted functional variants.

    • SecureDNA's hazard database is comprehensive, including:

      • BSAT and CCL listed agents

      • Australia Group, US ITAR, Chinese, and EU regulated sequences

      • Potential pandemic pathogens (PPPs)

      • Newly documented or emerging threats

    • The system is designed to accommodate future updates, including sequences known to contribute to pathogenicity or toxicity, even if not derived from regulated agents. This is especially relevant as the October 2026 version of the Framework will require some form of this type of function-based screening.

  • 3. Customer Verification and Legitimacy Assessment

    While SecureDNA's primary focus is on sequence screening, it can support customer verification processes.

    How SecureDNA Can Help:

    • SecureDNA's API can be integrated with existing customer and order management systems to flag orders containing SOCs, prompting the necessary additional verification steps.

    • SecureDNA’s Exemption Certification System allows for pre-vetted customers and orders to pass through screening without delay, while maintaining strong documentation for each of these orders.

  • 4. Reporting Potentially Illegitimate Orders

    SecureDNA can assist in the reporting process for potentially illegitimate orders.

    How SecureDNA Can Help:

    • The system can be configured to automatically generate reports for orders flagged as containing SOCs.

  • 5. Record Retention

    The Framework requires providers and manufacturers to retain screening records for at least three years.

    How SecureDNA Ensures Compliance:

    • SecureDNA's system can generate comprehensive reports of screening activities for auditing purposes.

    • These logs can be securely stored and easily retrievable for the required three-year period.

    • A future update will include the ability to optionally apply a cryptographic signature to the results, allowing you to demonstrate to an external auditor that the results were genuinely obtained and have not been altered.

  • 6. Cybersecurity

    The Framework emphasizes the importance of robust cybersecurity measures to protect sensitive information.

    How SecureDNA Ensures Cybersecurity:

    • SecureDNA employs state-of-the-art encryption for all data, both in transit and at rest.

    • The platform uses a sophisticated cryptographic method (Distributed Oblivious Pseudorandom Function) to ensure the privacy of DNA sequences during analysis.

    • SecureDNA's architecture prevents unauthorized access to the hazard database or customer information.

    • The system is designed to comply with relevant cybersecurity Executive Orders, standards, and frameworks, including NIST guidelines.

By leveraging SecureDNA's advanced features and capabilities, providers and manufacturers can ensure robust compliance with the OSTP Nucleic Acid Synthesis Screening Framework, enhancing biosecurity while supporting legitimate research and development in the life sciences.

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