Now accepting submissions to expand existing next-generation sequencing-based assays to detect respiratory RNA viral pathogens.
On August 23, 2021, BARDA's Division of Research, Innovation, and Ventures (DRIVe) opened a new area of interest (AOI) under the EZ Broad Agency Announcement (EZ-BAA) solicitation to expand the capabilities of existing next-generation sequencing diagnostics to agnostically detect any pathogenic respiratory RNA virus including new, emerging and existing viruses.
Next-generation sequencing diagnostics have been established for oncology and some genetic disorders, and such technology also is needed for infectious diseases due to growing health security challenges and threats. In a viral outbreak or pandemic, having agnostic tests – especially those which can detect any respiratory RNA virus and can be implemented rapidly without the need for additional regulatory approvals – is crucial.
Next-generation sequencing technology can detect and analyze viral genomes from any existing or emerging viruses in an unbiased manner compared to targeted polymerase chain reaction (commonly called PCR) and antigen assays. PCR and antigen assays require a significant effort to develop, verify, validate, and earn regulatory approval. In pandemic situations, next-generation sequencing assays could provide the capability for agnostic detection, especially with emerging respiratory pathogens and can be used on day one with appropriate regulatory approval. These tests also provide information critical 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.
Under this EZ BAA, BARDA will review concise abstract submissions for funding of next-generation sequencing-based agnostic diagnostics for respiratory RNA viruses. Our goal is to further verify and validate the technology, and provide support 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.
Abstracts may be submitted until 5:00PM ET on November 30, 2021. For additional information, see solicitation AOI #10: Next Generation Sequencing (NGS)-based Agnostic Diagnostic for Respiratory RNA Virus Pathogens (PDF - 286KB) in the Special Instructions 014 Issuance of the EZ-BAA (BAA-20-100-SOL-0002), and visit drive.hhs.gov/partner.
The EZ-BAA was created to provide a streamlined process through which BARDA and BARDA's Division of Research, Innovation, and Ventures (DRIVe) can review and accept applications for development funding of transformative products and technologies to protect Americans from health security threats. Since its inception, BARDA DRIVe's EZ-BAA solicitation has averaged more than one abstract submission per day while active, with awards made in as few as 30 days. The EZ-BAA has helped transform the contracting process and provide innovators, entrepreneurs, and organizations with a simplified and rapid mechanism to partner with the U.S. government. The application process is both business-friendly and easy to follow.