CBER Continues to Analyze Next-Gen Sequencing

Next-generation sequencing represents a potential for broad adventitious virus detection and is currently part of a new generation of testing under evaluation by the U.S. FDA. Arifa Khan, PhD, Sr. Investigator/Supervisory Microbiologist, CBER, discussed next-gen sequencing during the virtual PDA Europe Virus Forum on June 23.

She pointed to how next-generation sequencing led to the discovery of known and novel viruses missed by recommended routine assays. CBER has established genomic working groups to support research and develop a regulatory process for applications of next-generation sequencing. In addition, the Center is expanding in-house laboratory and bioinformatics expertise in this area. Her team is also involved with PDA’s Advanced Virus Detection Technologies Interest Group.

Discussions within the interest group and a multicenter virus spiking study are helping ensure development of five well-characterized reference virus stocks for next-generation platform evaluation and standardization. These virus stocks are porcine circovirus, human orthoreovirus, feline leukemia virus, human respiratory syncytial virus and Epstein-Barr virus. These stocks are available for next-generation sequencing evaluation via material transfer agreement. Khan is the point of contact for this. Her email is arifa.khan@fda.hhs.gov.

Khan also mentioned that the Office of Vaccines Research and Review (OVRR) has received an increase in requests to use next-generation sequencing as a rapid adventitious virus detection method by companies seeking to develop vaccines to protect against COVID-19. Within OVRR, she explained, next-generation sequencing data is considered on a case-by-case basis, primarily for supplementing or traditional testing. Sponsors should request a technical working group discussion and schedule a meeting with OVRR representatives to discuss how they intend to use the platform.

In her conclusion, she reiterated that these early discussions between industry sponsors and regulators are crucial as the technology is still evolving. These discussions can also lead to harmonization of next-generation sequencing requirements.

PDA members who want to be involved in efforts to harmonize requirements for next-generations sequencing are encouraged to join the Advanced Virus Detection Technologies Interest Group.