Medical Biological Defense (Op Sys Dev)

Abstract

The project supports technical upgrades of fielded medical devices and systems, including diagnostic systems and nerve agent treatment systems that contribute to the layered medical defenses against biological and chemical warfare threats facing U.S. Forces on the battlefield. In FY2023, the CBDP RDT&E Projects have been restructured to align to the CBDP portfolio. MB7 efforts in FY2022 progress to the Understand (UN7) portfolio. This restructuring is intended to provide standardization and alignment across CBDP research, development and acquisition efforts. Efforts in this Project include: (1) Next Generation Diagnostic System 1 (NGDS 1), and (2) MODERNIZATION MEDICAL (MOD MED) **Progresses to UN7 in FY2023** The NGDS is a family of systems providing diagnostic capabilities that address varied chemical, biological, and radiological (CBR) threats across the different echelons of the Combat Health Support System. NGDS systems provide Food and Drug Administration (FDA) cleared diagnostics to inform individual patient treatment and CBR situational awareness and disease surveillance. NGDS 1 provides deployable and laboratory-based combat health support units with FDA cleared biological warfare agent (BWA) and infectious disease assays on an existing commercial diagnostic device. NGDS 1 transitions to MOD MED starting in FY22. Modernization Medical (MOD MED) The MOD MED program supports improvements to fielded systems and supports post-approval Food and Drug Administration (FDA) requirements for devices and combination products. In FY23, in addition to continuing efforts for NGDS 1 and Alternative Autoinjector Manufacturer Capability (AUTOINJ), the NGDS 2 Man Portable Diagnostic System (NGDS 2 MPDS) is transitioning to MOD MED following its Milestone C decision. Under MOD MED, program efforts include FDA required post-marketing commitments and requirements for combination products (AUTOINJ) and system hardware and software upgrades for fielded NGDS (both NGDS 1 and NGDS 2 MPDS) that are required to maintain the capability for CBR threat and infectious disease identification and FDA-cleared diagnostics to inform individual patient treatment and CBR situational awareness and disease surveillance. FY23 funding initiates development of bacterial versus viral (B vs. V) assay and Flexible Cartridge (FlexCart). The B vs. V assay will detect and distinguish between bacterial and viral infections. The FlexCart effort enables the DoD to address emerging threats using Cepheid-configured cartridges.

Document Details

• Document Type: Project
• Publication Date: Oct 01, 2023
• Source ID: MB7_0607384BP_7_0400_PB_2023

Tags

Readers

• Critical Infrastructure Protection in CBRN and WMD Threats.