Epidemic Management and Prevention The division is unique in that it has both a research and development mission and an operational mission. The research portfolio includes diagnostic approaches that employ nextgeneration sequencing as well as identification and verification of host biomarkers that could be used for diagnostic applications. Operationally, USAMRIID’s Special Pathogens Laboratory (SPL) is one of three National Laboratories within the Centers for Disease Control and Prevention (CDC) Laboratory Response Network (LRN), as well as a member of the Defense Laboratory Network. The SPL is accredited under the Department of Defense Clinical Laboratory Improvement Program (CLIP) to perform regulatory-compliant diagnostic testing for patient care. These capabilities— spanning research and development, support of FDA clearance, and operational diagnostic testing—position USAMRIID as a unique military asset that can be utilized to support the entire pathway associated with performing regulatory-compliant diagnostic testing for patient care. The Ebola virus disease outbreak is an excellent example of how USAMRIID contributed to the U.S. response to the crisis by providing assay development and validation, regulatory authorization and operational testing to support Ebola diagnosis worldwide.
Ebola Virus Outbreak Support
Surprisingly, USAMRIID had very few hurdles to overcome when
responding to the Ebola virus disease outbreak with a regulatorycompliant diagnostic capability. In fact, the Institute had already established positive relationships with FDA and CDC before that outbreak to enable a swift response to just such an emergency. Preparations began with a briefing to FDA in December 2009 on the work of USAMRIID and the DoD to standardize assay development processes and performance. From these discussions came a new initiative to improve readiness for biological contingencies. USAMRIID would pre-position its data on diagnostic assay performance with the FDA so that, in the event of an outbreak, an Emergency Use Authorization (EUA) could be initiated in order for those assays to be used in humans. By July 2010, FDA and DoD had agreed on the pre-EUA study protocols and 73 assays were submitted by USAMRIID and logged into the FDA database. In July 2011, USAMRIID completed the first data set that was accepted by the FDA, which was for the Ebola Zaire assay. By March 2013, all of USAMRIID’s filovirus (Ebola and Marburg virus) pre-EUAs, eight in all, had been completed and accepted by the FDA. On July 9, 2014, in light of the escalating situation in Western Africa, FDA and DoD began discussions regarding an EUA for the Ebola Zaire assay that USAMRIID had developed. Thanks to forethought, careful planning and pre-positioned data, it took less than 30 days for the EUA to be authorized. On August 5, 2014, the U.S. Army Office of The Surgeon General (OTSG) was notified that
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Combat & Casualty Care - Spring 2016 Issue