DHA26BZ01-NV004 — Development of Wearable Device for Detecting Biomarkers and Treating Viral and Bacterial Infections

Award Maximum: $300,000 Period of Performance: 6 months Phase Type: Phase I

OBJECTIVE: Develop a non-invasive wearable device that can discretely detect biomarkers for and provide initial broad-spectrum treatment for pan-viral and pan-bacterial infections. If fielded for military use, it may require additional security measures.

DESCRIPTION: The DHA Strategic Research Plan (SRP): Environmental Exposures (June 2024) lists two capability requirements under the "Assess" and "Treat" capability areas that align with this proposal: Environmental Detection and Health Risk Assessments under Assess and Environmental Exposures Treatment under Treat. In addition, the DHA SRP: Military Infectious Diseases (May 2024) lists three capability requirements under the "Prevent", "Treat", and "Enable" capability areas that align with this proposal: Prevention of Military Relevant Endemic and Emerging Infectious Diseases under Prevent, Treatment of Military Relevant Endemic and Emerging Infectious Diseases under Treat, and Core Competencies under Enable.

The Department of the Air Force (DAF) is looking for an advanced, non-invasive (does not break the skin or physically enter the body) wearable device (i.e., flash/continuous glucose style monitoring) capable of qualitatively detecting all-viral and all-bacterial infections using discrete biomarkers for such infections: TRAIL, MxA, CD46, IP-10, PTX3, or other non-blood based biomarkers (saliva, sweat, etc.) for viral infections and CRP, PCT, IL-6, IL-8, CD35, CD55, CD64, pro-ADM, or other non-blood based biomarkers (saliva, sweat, etc.) for bacterial infections. The end goal is a wearable device that discretely detects viral and bacterial infections and renders initial, broad-spectrum anti-viral or anti-bacterial treatment(s) at austere operational environments where no immediate medical countermeasures and no other detection capabilities are available until casualties are evacuated to locations with more robust medical resources for additional and specific differentiation and treatment. At a higher echelon of care, medical personnel must be able to receive data from the device to find out what category of threats (viral or bacterial) has triggered a biomarker detection and what corresponding treatments have been rendered to the affected force before providing more advanced care.

By continuously monitoring validated biomarkers, this device will empower warfighters to detect and respond to biological threats early, enhancing their survivability and operational effectiveness in high-threat theaters and mitigating risks to mission and force. This Air Force Medical Command initiative improves force health protection and ensures mission success. Dual-use functionality of this technology will focus on civilian healthcare systems.

PHASE I: Phase I will provide proof of feasibility on biomarker detection capabilities and initial treatment integration under various operational parameters. Efficacy must be demonstrated in progress documents via reproducible testing results against, at minimum, the bacterial and viral biomarkers listed in the description. Specifically, provide a detailed analysis of selected biomarkers (and their thresholds to indicate infections) and biosensor technologies, demonstrating their critical role in detecting and differentiating viral and bacterial infections as well as initial treatment considerations for such infections. This investigation will systematically address key attributes such as device detection capabilities, continuous monitoring in austere operational environments, and operator interface design. Additionally, results will outline specific power supply requirements for the system and propose resilient solutions that guarantee the continuity of health status data, whether the device is actively deployed or in storage. This Phase will demonstrate the feasibility of a wearable device for DAF warfighters and explore significant opportunities for standardization across the Department of War (DoW).

PHASE II: Phase II will focus on development and testing of one to five wearable prototypes:

Biomarker Detection: Qualitatively detect pan-viral and pan-bacterial infection biomarkers to achieve 95% sensitivity and 95% specificity or higher. Durability and Design: Ruggedized and capable of operating in a wide range of environments and all-weather conditions (i.e., 0°F to 120°F operating temperatures and up to 100% humidity). The device must be able to withstand physical impacts (i.e., repeated contacts with body armor or repeated drop from 6 ft on hard surface) as well as prevent chafing and potential detachment (i.e., no thicker than 5 mm). Materials must be fully compatible with military uniforms and equipment. Monitoring Frequency and Power: Continuous monitoring with a maximum interval of 5 minutes, and the power must continuously operate for a minimum of 30 days without a need to recharge. Solar power is acceptable. User Interface: Infection alert status must be a simple, intuitive format, using color codes, audible alerts and/or vibration, even when the device is worn under protective gear, allowing warfighters to rapidly manipulate functions (i.e., reset, turn on/off alarms, system restarts) by touching or tapping. One to five prototype(s) must be delivered. Prototype(s) must have wireless integration allowing for secure data storage and transmission (ie. military grade blockchain encryption and HIPAA/Privacy Act compliant). Detailed initial test and evaluation results and validation process must be delivered with the prototypes. An applicable Food and Drug Administration (FDA) regulatory strategy outlining requirements for testing from safety and effectiveness must be included as well as how FDA approval will be received.

PHASE III DUAL USE APPLICATIONS: Phase III will involve deployment, testing, evaluation, and improvement of the mobile platform for military (and civilian) use. FDA approval is the end goal of this Phase. The inherent dual-use capability of this technology presents opportunities for integration across the military and within civilian healthcare systems. Specifically, target applications include DAF Deployed Personnel: enhancing force health protection for at-risk personnel vulnerable to biological threats, with potential application across the DoW. Commercial applications include civilian healthcare facilities specifically in rural communities: enabling civilian hospitals to remotely monitor and render initial treatment for at-risk patients prior to further patient management.