The Department of Defense (DOD) is seeking proposals for the development of a product capable of rapidly identifying military-relevant pathogens from environmental sources, as part of the SBIR program, specifically under the Direct to Phase II initiative. The objective is to create and validate a material product that can effectively detect bacteria, viruses, and fungi in various environmental samples, addressing the urgent need for improved environmental surveillance methods to enhance public health and military readiness. This initiative is particularly significant given the increasing recognition of environmental surveillance as a critical tool for monitoring outbreaks and assessing risks associated with pathogens, with potential applications in both military and civilian contexts. Proposals are due by April 30, 2025, and interested parties can find more information and submit their applications through the DOD's SBIR website at https://www.dodsbirsttr.mil/topics-app/.

## Description

Environmental surveillance has become increasingly recognized as a potentially valuable tool for identifying and tracking pathogens. Environmental surveillance has proven useful for pathogens such as poliovirus and SARS-CoV-2 to monitor for outbreaks and vaccine response. The potential benefits of these surveillance efforts include being an early warning system, monitoring the effectiveness of an outbreak response, testing the effectiveness of hospital wastewater treatment systems, identifying environmental risk factors for disease transmission to be targeted by public health efforts and tracking emerging resistance to bacteria in a local community.<ol><li>Within the military, additional benefits include pre and during exercise monitoring, deployment site transmission risk assessments and source identification of outbreaks. The 2023 Department of Defense Biodefense Posture Review (BPR) identified the need to prioritize environmental bio surveillance in efforts to create an effective early warning system for force health protection. The BPR tasked the Department of Defense with accelerating its research and innovation in this area.</li><li>A cost model analysis of wastewater surveillance compared to human swab surveillance for SARS-CoV-2 at US Air Force Bases calculated a $10-18.5 million decrease in costs for wastewater surveillance.</li><li>Identifying a faster detection method will not only further reduce costs but provide faster results. While most of the recent impetus on environmental surveillance has been focused on SARS-CoV-2, additional pathogens are also now targeted for monitoring. The CDC National Wastewater Surveillance System monitors for influenza, RSV, Mpox and SARS-CoV-2. The National Academies of Sciences, Engineering, and Medicine identified antimicrobial resistant bacteria as ideal targets for wastewater surveillance based on the public health need, feasibility, and usefulness of community wide data.</li><li>One of the major limitations to environmental surveillance are the laboratory supplies and equipment, analysis time and training required. As a result, routine surveillance in the most likely environments for outbreaks or deployed settings is often unattainable.</li></ol>US Army Public Health Command have developed a deployment risk assessment guide for gastrointestinal illness from reused wastewater based on E.coli found in the water. Without the capability to measure E. coli in the field, this tool will go underutilized. A product that could be adapted to measure other pathogens would allow for the creation and application of similar tools that assess risk for skin and upper respiratory infections due to water or other environmental exposures. Current Periodic Occupational and Environmental Monitoring Summaries (POEMS) of deployment sites do not directly assess for microbiological risks but focus on particulate matter size and metals in the air, organic compounds, metals, pesticides in the soil and chemicals in the water. This topic area aims to support the development of a fast, easy to use, adaptable and durable product for the detection of military relevant viruses, bacteria and/or fungi from environmental samples.

## Objective

This topic is intended for technology proven ready to move directly into Phase II and is accepting Direct to Phase II proposals only. Develop and validate a material product that can effectively and rapidly identify military relevant bacteria, viruses and/or fungi from environmental sources. 

## Phase I

This topic is intended for technology proven ready to move directly into Phase II. Therefore, the offeror must be able to demonstrate and provide documentation to substantiate that the scientific and technical merit and feasibility described in Phase I has been met and describes the potential commercial applications. Documentation should include all relevant information including, but not limited to technical reports, test data, prototype designs/models, and performance goals/results. A completed Phase I will have demonstrated successful feasibility testing of a product that can identify at least one military relevant virus, bacteria of fungi from at least one environmental source. The feasibility testing could have been on actual environmental samples or spiked samples with a traditional laboratory comparator. The identification technology should have the potential to be expanded to other pathogens. Ideally, the product should be able to identify the target pathogen at the species level. Data on time to detection, repeatability, reproducibility and limits of detection on environmental samples should be provided. The pathogen identified should not be a potential biowarfare/incident agent but biological threats that could impact the military from the environment whether that is from wound infection risk, highly transmissible pathogens or potential pandemic threats. The environmental source could be air, water or soil. In addition, specifications of the planned prototype should be provided. 

## Phase II

This phase will focus on the development and testing of a prototype. The objectives for Phase II include the construction of a prototype that addresses the REASSURED WHO guidelines for point of care testing. Priorities for product design and technology should be in time to identification with a goal of less than 4 hours, minimal to no pre-processing of the source sample, ease of use, minimal energy requirements and capacity for adapting the detection technology to other pathogens/sample sources. The size of the prototype should be amenable to easy transportation and implementation by 1-2 people. Weight should be limited to approximately 30-45 pounds. Ideally, the prototype will be comprised of one unit that collects, processes and analyzes the environmental material. Include details on further development plans for a product that is durable and can be used in austere conditions. The performance of further feasibility testing during this Phase will be conducted. By the end of Phase II, a prototype that demonstrates the reliable identification of at least one virus, bacteria, or fungi from at least one environmental source. Enough prototypes should be constructed to meet Phase II testing goals. 

## Phase III: Dual Use Applications

In addition during this phase expansion to other pathogens and environmental sources should occur. This product could be used by civilian and military hospitals to assess their wastewater treatment systems, implemented into environmental monitoring programs such as those in food factories, used by public health organizations as an early warning system for potential outbreaks or identify public health risk contributors (eg. antibiotic resistant bacteria found in run-off from farms treating animals with antibiotics). The product could be utilized for wide scale surveillance programs such as those funded by the DoD&rsquo;s Global Emerging Infections Surveillance program. Potential military benefits could include incorporating biological threat testing into their environmental risk assessments of deployment and field exercise sites worldwide. Funding for further development efforts could be sought from such programs as the Joint Warfighter Medical Research Program, Biomedical Advanced Research and Development Authority or Medical Technology Enterprise Consortium.

Rapid Identification of Pathogens from Environmental Resources (Direct to Phase II)

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