Medical Biological Defense (Op Sys Dev)
Abstract
The project supports technology refresh of fielded medical diagnostic systems and associated capabilities (e.g., assays) that contribute to the layered medical defenses against biological warfare agent threats facing U.S. Forces in the field. Efforts in this project include: (1) Next Generation Diagnostic System (NGDS) The NGDS is a family of systems providing increments of diagnostic capabilities over time that address varied CBR threats across the different echelons of the Combat Health Support System. The mission of the NGDS is to provide CBR threat and infectious disease identification and Food and Drug Administration (FDA) cleared diagnostics to inform individual patient treatment and CBR situational awareness and disease surveillance. NGDS 1 improves diagnostic capabilities in deployable and laboratory-based combat health support units. NGDS 1 offers improved operational suitability and affordability over legacy systems by developing FDA cleared biological warfare agent (BWA) and infectious disease in vitro diagnostic (IVD) assays on an existing commercial diagnostic device with a well-established FDA regulatory history and pipeline of commercial non-BWA infectious disease diagnostic tests.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2021
- Source ID
- MB7_0607384BP_7_0400_PB_2021
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