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 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, e.g. Anthrax, Plague, Tularemia, Q-Fever, H5 Avian, Influenza A&B, etc. An expanded influenza detection panel covering six new assays was cleared on Sept 13, 2011. Additionally, the JBAIDS Platinum Path Extraction Kit (PPEK) Bridging Study contract was awarded on Oct 20, 2011; this will allow the PPEK to be used with the Anthrax, Plague, and Tularemia IVD kits. JBAIDS achieved full operational capability (340 systems delivered all Services) in July 2011. JBAIDS efforts in 2012-2015 will focus on adding new surveillance food and water pathogen detection assays. Also, the development team will focus on completing Pre-Emergency Use Authorization (Pre-EUA's) packages annually for FDA review. These operational development RDT&E funds will be used to oversea the configuration management of the system to include the conduct of software security information assurance (IA) updates on fielded software and monitor analyzer/laptop parts obsolescence. The Next Generation Diagnostics System (NGDS) addresses the mission needs identified in the CBRN Field Analytics ICD (2010). The NGDS is envisioned to be 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 CBRN warfare threat identification and FDA-cleared diagnostics to inform individual patient treatment, CBRN situational awareness, and disease surveillance. NGDS Increment 1 Deployable Component will significantly improve diagnostic capabilities for deployable combat health support units (role 3) while also improving operational suitability and affordability. The NGDS Increment 1 Deployable Component is intended to replace the legacy Joint Biological Agent Identification and Diagnostic System (JBAIDS) beginning in FY17. The NGDS Increment 1 Service Laboratory Component is intended to provide high throughput Biological threat identification, characterization and diagnostics to fixed site CONUS and OCONUS laboratories operated by the Army, Navy and Air Force in coordination with the Armed Forces Health Surveillance Center. NGDS Increment 2 is intended to provide advanced diagnostics for biological pathogens and toxins, diagnostics for chemical and radiological exposures and to provide capability to lower echelons of care.

Document Details

• Document Type: Project
• Publication Date: Oct 01, 2014
• Source ID: MB7_0607384BP_7_0400_PB_2014

Tags

Readers

• Critical Infrastructure Protection in CBRN and WMD Threats.
• Infectious Disease/Epidemiology