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). JBAIDS is an evolutionary development program. 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 bacteria and virus agents in environmental surveillance 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, e.g. Anthrax, Plague, Tularemia, Q-Fever, H5 Avian, Influenza A&B, etc. An expanded influenza detection panel covering six new assays were cleared on Sept 13, 2011. Additionally, the JBAIDS Platinum Path Extraction Kit (PPEK) Bridging Study contract was awarded on Oct 20, 2011; this study will allow the PPEK to be used on the Anthrax, Plague, and Tularemia IVD kits. JBAIDS achieved full operational capability (340 systems delivered all Services) in July 2011. Future JBAIDS efforts in 2012-2016 using MB7 RDT&E funding, will focus on adding new surveillance food and water pathogen detection assays and starting the Glanders (Burkholderia) IVD kit effort. Also the development team will focus on completing two Pre-Emergency Use Authorization (Pre-EUA's) packages annually for FDA review. These sustainment RDT&E funds will also be used to conduct software security information assurance (IA) updates on fielded software and monitor analyzer/laptop parts obsolescence.

Document Details

• Document Type: Project
• Publication Date: Oct 01, 2013
• Source ID: MB7_0607384BP_7_0400_PB_2013

Tags

Readers

• Infectious Disease/Epidemiology
• Naval Mine Countermeasure Systems Development.
• Oncology and Biomarker-Based Cancer Detection.