January 9, 2018
International Gene Synthesis Consortium Updates Screening Protocols for Synthetic DNA Products and Services
SAN DIEGO, Jan. 3, 2018 /PRNewswire/ — The International Gene Synthesis Consortium (IGSC), an organization of the world’s leading gene synthesis companies, today announced that it has published an updated Harmonized Screening Protocol that enables providers of synthetic DNA products to meet requirements for evaluating genetic sequences of orders, vetting of customers and handling of data. Uniform screening detailed in the protocol are designed to allow the promise of gene synthesis technologies to be realized across numerous industries while minimizing risk for abuse as well as maintaining compliance with HHS Guidance for Double Stranded DNA Providers and other international standards.
The first significant area of protocols, related to the gene sequence screening, details steps to evaluate the complete DNA sequence of synthetic gene orders against a Regulated Pathogen Database and multiple internationally coordinated sequence databases. These processes enable any synthetic gene orders related to potentially dangerous sequences to be identified before an order is fulfilled. The orders are then reviewed by a human expert using heightened screening criteria, which may lead to an order needing to meet additional requirements or being rejected.
The second significant area of protocols, related to customer screening, contains measures and steps to review the individual and organization placing the order. Any synthetic gene orders containing sequences for regulated pathogens or toxins may only be provided to verified government laboratories, universities and industrial laboratories demonstrably engaged in legitimate research. All customer screening processes ensure that synthetic gene orders are only provided to validated end-users, not distributors or resellers.
Additional processes covered in the Harmonized Screening Protocol establish best practices related to record keeping, order refusal and reporting, regulatory compliance and consortium collaborative activities. The IGSC will continue to review and revise the protocol to ensure compliance with any changes to international standards. The Harmonized Screening Protocol is publicly available on the IGSC website.
Membership on the Rise
Over the past several years, IGSC membership has grown internationally and is expected to continue to rise with the rapid advancements in the field of synthetic biology. Organizations interested in advancing and shaping the field can find the latest information about IGSC membership and our initiatives at our new website at www.genesynthesisconsortium.org.
About the IGSC
The International Gene Synthesis Consortium (IGSC) is an industry-led group of gene synthesis companies and organizations formed to design and apply a common protocol to screen both the sequences of synthetic gene orders and the customers who place them. In collaboration with national and international government organizations and other interested parties, IGSC also promotes the beneficial application of gene synthesis technology while safeguarding biosecurity. Screening and vetting policies implemented by IGSC members ensure compliance with national and international standards for biosecurity. Since forming in 2009, IGSC has grown to represent approximately 80% of gene synthesis capacity worldwide. For more information about IGSC, visit www.genesynthesisconsortium.org.