Medical Countermeasure Systems (MCS) – Diagnostics

DESCRIPTION

The mission of Medical Countermeasure Systems (MCS) — Diagnostics (DX) is to develop, acquire, integrate and field identification technologies and Food and Drug Administration (FDA) cleared diagnostic devices intended for service members to aid in the early diagnosis, prevention and treatment of the effects of exposure to chemical, biological and radiological agents.

The Diagnostics portfolio consists of:

Joint Biological Agent Identification and Diagnostic System (JBAIDS): Fielded
A reusable, portable, modifiable biological agent identification and diagnostic system capable of rapid, reliable and simultaneous identification of multiple biological agents and other pathogens of operational concern. Sixteen pathogen surveillance assay kits are deployed covering 14 Biological Warfare (BW) agents. In addition, seven FDA cleared In Vitro Diagnostic (IVD) test kits (Anthrax, Tularemia, Plague and QFever) and the Platinum Path Extraction Kits are available through the Defense Logistics Agency. In addition, the JBAIDS has eight FDA approved prepositioned Emergency Use Authorization data packages for IVD assays (Ebola Zaire, Ebola Sudan, PanEbola, Marburg Ci67, Marburg Musoke, Marburg RAVN, Marburg Angola and PanMarburg) for the identification of low-probability, high-consequence pathogens in clinical samples that can be deployed in the event of a declared health emergency.
Next Generation Diagnostic System (NGDS) Increment 1:
A FDA-cleared reusable, adaptable biological pathogen diagnostic and identification system capable of rapidly analyzing clinical and environmental samples. The BWA Warrior Panel (Anthrax, Plague, Tularemia, Q Fever, Ebola and Marburg) is cleared by the FDA for use with blood culture, whole blood and sputum samples to aid in human diagnosis. Fielding to Air Force units began in May 2017. The Sentinel Panel includes targets for Anthrax, Tularemia, Q Fever, Ebolavirus, Marburg, Y.pestis, Burk psuedomallei, Burk mallei, Brucella sp, Brucella melitensis, Rickettsia Prowazekii, EEE, VEE, WEE, Orthopox, Variola, Ricin, Bot, training assays (Bacillus globigii, Bacillus thuringiensis, yeast) for surveillance and environmental applications.
NGDS – 2:
A family of systems that provides expanded diagnostic capabilities to lower echelons of care (roles of care 1-3) and complement diagnostic capabilities by addressing objective chemical, biological and radiological diagnostic threats.

BENEFIT TO THE SOLDIER

JBAIDS: Provides rapid positive identification and diagnostic confirmation of Biological Warfare Agents and other pathogens of operational concern.
NGDS: NGDS diagnostic capabilities will be employed in Army and Air Force (Role 3) and Navy (Role 2 and 3) deployable Combat Health Support units, with applicability to routine healthcare at higher echelons. NGDS Increment 1 will support accurate patient treatment, force health protection and chemical, biological, radiological and nuclear situational awareness.

SPECIFICATIONS

JBAIDS:

Sample Preparation Time: 25-65 minutes per sample
Total Time to Result: 90-135 minutes (DNA vs RNA)
Samples analyzed per run: 7 samples (including controls)
Number of organisms analyzed per run: Max 5 targets (without inhibition controls); operator must know what to test for
Types of organisms analyzed: Biological Warfare Agents, Influenza
Configuration: instrument, laptop with software, support equipment, sample preparation kits and consumables
Footprint (analyzer, support equipment and consumables): ~1,150 pounds and 87 cubic feet

NGDS:

Sample Preparation Time: 5 minutes per sample
Total Time to Result: 70 minutes
Samples analyzed per run: 1 sample – multiple agents
Number of organisms analyzed per run: 14-27 targets depending on panel
Types of organisms analyzed: Biological Warfare Agents, many common infectious disease agents (125+ additional targets)
Configuration: instrument, laptop with software, sample preparation kits and consumables
Footprint (analyzer, support equipment and consumables): 62 pounds and 6 cubic feet

PROGRAM STATUS

4QFY18: Full Rate Production Decision

PROJECTED ACTIVITIES

FY19-FY23:

All JBAIDS replaced with NGDS Increment 1
NGDS-2: Man Portable Diagnostics System (MPDS) Milestone B, MPDS Milestone C, ChemDx Milestone B, ChemDX Milestone C
FY19: NGDS Increment 1 Army IOC

FY20: