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CBRN Diagnostics and Biodosimetry

Diagnostic tests to inform the use of medical countermeasures following a Chemical, Biological, or Radiological or Nuclear (CBRN) incident is a critical response capability. Diagnostics inform the appropriate use of medical countermeasures, minimizing the quantity of said countermeasures that must be stockpiled. They also inform follow on care of casualties and they reassure concerned citizens that have not been injured during an incident. BARDA funds the development of diagnostic countermeasures for use in central laboratory facilities and at the point of care.

The diagnostics developed for CBRN threats are guided by the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) implementation plan. BARDA advertises specific diagnostic developments of interest through the CBRN Broad Agency Announcement and specific targeted solicitations.

BARDA has funded 11 contracts for development of Biodosimetry diagnostic tools for radiation exposure threats. 6 of these 11 contractors have shown the feasibility of their proposed diagnostic and continue to receive BARDA funds and support for advanced development. While BARDA has not yet funded diagnostic developments for biological and chemical threats, future plans will address these areas once the specific needs and performance parameters for the products are better defined.

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BARDA’s near-term strategy for anthrax vaccines leverages funding to support improvements in the utility and capability of BioThrax®. Significant progress toward this goal includes delivery of BioThrax® to the Strategic National Stockpile (SNS) under PBS funding and submission in late 2014 of the Supplemental Biologics License Application (sBLA) for post-exposure prophylaxis (PEP) indication, with anticipated FDA licensure in 2015. Projects are ongoing to expand the vaccine’s label indication for post-exposure prophylaxis, increase the current U.S. manufacturing production capacity and support the development of an enhanced vaccine formulation candidate with adjuvant (NuThrax®) that may produce a more rapid immune response with fewer doses required for protection. NuThrax® will enter Phase 3 clinical development in 2015 and potentially transition to procurement under PBS later in the decade. Successful execution of this near-term strategy may have a significant impact on U.S. preparedness against an anthrax attack and provide a substantial reduction in costs across the PHEMCE.

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