MEDICAL BIOLOGICAL DEFENSE (OP SYS DEV)
Abstract
This Project provides for the upgrade and modernization of fielded Medical Biological defense equipment/systems including the Joint Biological Agent Identification and Diagnostic System (JBAIDS) and Next Generation Diagnostic Systems (NGDS) suite. JBAIDS is a commercial off-the-shelf development/production effort started in August 2003 that focused on rapid development and fielding efforts to deliver a critical capability to identify bacterial and viral agents in environmental surveillance and clinical specimen sample types. By 2005, 16 biological warfare (BW) agent surveillance detection kits were fielded along with the first JBAIDS in vitro diagnostic (IVD) assay cleared by the U.S. Food and Drug Administration (FDA). JBAIDS currently has seven IVD kits cleared by the FDA, JBAIDS achieved full operational capability (340 systems delivered all Services) in July 2011. JBAIDS efforts in 2012-2016 will focus on adding surveillance food and water pathogen detection assays as well as laptop retrofit and fielding. Also, the development team will focus on completing Pre-Emergency Use Authorization (Pre-EUA's) packages annually for FDA review. The operational development RDT&E funds will be used to oversee the configuration management of the system to include the conduct of annual software security information assurance (IA) updates on fielded software and monitor analyzer/laptop parts obsolescence. The NGDS is an evolutionary acquisition family of systems to provide increments of capability over time across many echelons of the Combat Health Support System. The mission of the NGDS is to provide Chemical, Biological and Radiological (CBR) threat and infectious disease identification and U.S. Food and Drug Administration (FDA)-cleared diagnostics to inform individual patient treatment as defined in the approved NGDS Capabilities Development Document (CDD) and CBR situational awareness and disease surveillance as defined in the Common Analytical Laboratory (CALS) CDD. NGDS Increment 1 (NGDS Inc 1) will significantly improve diagnostic capability for deployable combat health support units (Role 3) while also improving operational suitability and affordability by developing FDA cleared biological warfare agent (BWA) and infectious disease in vitro diagnostic (IVD) assays on existing commercial diagnostic device with a well established FDA regulatory history and pipeline of commercial non-BWA infectious disease diagnostic tests. The NGDS Inc 1 program has a streamlined MS A to MS C - Limited Deployment acquisition strategy. BA7 funds will be used to complete the development of assays initiated during the Technology Maturation and Risk Reduction (TMRR) phase and needed for JBAIDS replacement as well as fund the development of three objective assays (Burkholderia, Alpha Virus, and Orthopox).
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2016
- Source ID
- MB7_0607384BP_7_0400_PB_2016
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (OP SYS DEV)
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- Child Accomplishment: 2) JBAIDS
- Child Accomplishment: 3) JBAIDS
- Child Accomplishment: 4) JBAIDS
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- Child Accomplishment: 9) SBIR/STTR
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