World's Top Gene Synthesis Companies Establish Tough Biosecurity Screening Protocol
International Gene Synthesis Consortium (IGSC) to Coordinate Best Practices in Risk Reduction
Five gene synthesis companies announced agreement that they will apply a common screening protocol to promote biosecurity in the gene synthesis industry. By screening the sequences of synthetic gene orders and the customers who place them, the companies aim to support government efforts to prevent the misuse of gene synthesis technology. Blue Heron Biotechnology, DNA2.0, GENEART, GenScript and Integrated DNA Technologies together represent approximately 80% of the global gene synthesis capacity, according to the companies. They have formed the International Gene Synthesis Consortium (IGSC) to coordinate ongoing best practices development and to work together with governments and others concerned to promote the beneficial application of gene synthesis technology and to safeguard biosecurity.
"Safety and security are a chief priority for all of the IGSC companies, as the growth of the gene synthesis industry depends on an impeccable safety record. Each of the five founding companies has demonstrated a strong commitment to the safe delivery of synthetic DNA by implementing strong internal biosecurity practices", said Prof. Dr. Ralf Wagner, CEO and CSO of GENEART. "We hope that the IGSC will help to encourage effective collaboration with government and policy organizations and promote internationally consistent approaches to safety and security in gene synthesis."
The IGSC's "Harmonized Screening Protocol for Gene Sequence & Customer Screening to Promote Biosecurity" establishes the five core components that each IGSC company will apply to promote the safe use of synthetic genes:
- Gene Sequence Screening: The complete DNA sequence of every synthetic gene order is to be screened against a Regulated Pathogen Database developed by the consortium and one or more of the internationally coordinated sequence reference databanks (i.e., NCBI/GenBank, EBI/EMBL or DDBJ). Amino acid sequences of possible translation products for each synthetic gene ordered will also be screened.
- Gene Customer Screening: A complete and thorough screening of each potential gene synthesis customer will be conducted to establish identity and clearance for delivery of genes ordered, in accordance with national guidelines. The screening protocol assigns special considerations to the ordering of Select Agent genes.
- Record Keeping: The IGSC companies will keep all screening, customer and order records for at least eight years.
- Order Refusal & Reporting: IGSC companies reserve the right to refuse to fill any order and to notify authorities upon identifying potentially problematic orders, coordinating efforts with local and national law enforcement and intelligence agencies.
- Regulatory Compliance: IGSC companies comply with all applicable laws and regulations governing the synthesis, possession, transport, export and import of gene synthesis and other products.
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