An agnostic test to detect any respiratory RNA virus, including new and emerging viruses, that can be implemented rapidly and without the need for additional regulatory approvals in future pandemic situations.
Next-generation sequencing diagnostics have been established for oncology and some genetic disorders, and such technology is also needed for infectious diseases due to health security threats. In a viral outbreak or pandemic, having agnostic tests – which can detect any respiratory RNA virus and can be implemented rapidly without the need for additional regulatory approvals – is crucial.
NGS technology can detect and analyze viral genomes from any existing or emerging viruses in an unbiased manner compared to targeted polymerase chain reaction (PCR) and antigen assays. PCR and antigen assays require a significant effort to develop, verify, validate, as well as earn regulatory approval. In pandemic situations, next-generation sequencing assays could provide the capability for agnostic detection ability, especially with emerging respiratory pathogens and can be used on day one with appropriate regulatory approval. These tests also provide information crucial to timely and actionable patient care.
Despite the promise of next-generation sequencing, the commercialization of such platforms has not yet occurred, and no U.S. Food and Drug Administration (FDA)-cleared agnostic diagnostic currently exists for use in pandemic situations.
Our focus is to further verify and validate the existing NGS-based assays for detection of respiratory RNA viruses, and support them through FDA approval. We expect that this approach will help to prepare the U.S. and potentially the world for future pandemics involving respiratory RNA pathogens. Expanding on this technology eventually could open up other opportunities for agnostic infectious disease diagnostics.