DOD SBIR 24.4 Annual

Active
Yes
Status
Open
Release Date
October 3rd, 2023
Open Date
October 3rd, 2023
Due Date(s)
March 31st, 2025
Close Date
March 31st, 2025
Topic No.
DHA244-D001

Topic

Sample Collection and Processing Methods to Support Battlefield Wound Infection Diagnostics (Direct to Phase II)

Agency

Department of DefenseN/A

Program

Type: SBIRPhase: BOTHYear: 2024

Summary

The Department of Defense (DOD) is seeking proposals for a Small Business Innovation Research (SBIR) program focused on the topic of "Sample Collection and Processing Methods to Support Battlefield Wound Infection Diagnostics (Direct to Phase II)". The Defense Health Agency is the branch responsible for this topic. The objective is to develop a simple-to-use sample collection and processing method capable of preparing an adequate specimen for the identification and accurate detection of specific fungal and/or bacterial species commonly associated with complex battlefield wound infections. The technology should be suitable for use in far-forward deployed environments. The current diagnostic capabilities for battlefield wound infections are limited and time-consuming, resulting in delays in treatment and medical intervention decisions. The proposed technology should enable rapid diagnosis (less than 2 hours) at the point of injury, improving patient outcomes and reducing morbidity and mortality. The technology should be compatible with wet/dry environments, require minimum logistical support, and be stable in long-term storage. It should also be easy to use with little training and provide unambiguous primary output. The technology must include a plan for FDA clearance and should align with CLIA-waived complexity standards. The SBIR program consists of three phases: Phase I focuses on demonstrating scientific and technical feasibility, Phase II involves refining the technology and integrating it with a rapid diagnostic platform, and Phase III aims to secure FDA approval and transition the technology for commercial use in both civilian and military settings. The proposal submission deadline is March 31, 2025. More information can be found on the grants.gov website or the DOD SBIR/STTR Opportunities page.

Description

OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Military Infectious Disease

 

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 a simple-to-use sample collection and processing method capable of preparing an adequate specimen for subsequent identification and accurate detection of specific fungal and/or bacterial species, such as Mucorales, Aspergillus spp., Fusarium spp, Pseudomonas aeruginosa, Escherichia coli (E. Coli), Staphylococcus aureus, and Streptococcus spp., that are often associated with complex battlefield wound infections for use in far-forward deployed environments.

 

DESCRIPTION: Battlefield wound infections are associated with significant morbidity and mortality (8-12% mortality). Early identification and treatment are critical to prevent loss of limb and/or loss of life. A Warfighter with blast and/or combat related wounds are exposed to various environmental pathogens to include bacteria and fungi in theater. Up to 32% of battlefield wound injures have been reported to develop follow-on infections with soft-tissue infections being the predominant (~66%). Current battlefield wound infection diagnostic capabilities are limited and comprised of traditional microbiology and culture procedures that yield diagnostic results in one (1) – three (3) days (i.e. bacterial infections) and potentially as long as six (6) weeks (i.e. fungal infections). These methods are insensitive and are heavily dependent on clinical and microbiological expertise. Furthermore, these capabilities are only located at higher roles of care, further from the point of injury and often delays treatment and medical intervention decisions. Proper sample collection methods and/or procedures are necessary to preserve the sample matrix to ensure high accuracy in sensitivity and specificity of the diagnostic test. Due to various factors of complicated wounds, the sample collection and processing method should take into consideration the complex nature of wound specimen types (biopsy, exudate, fluid aspiration) that can make sample processing more challenging.

 

Rapid diagnosis of battlefield infections in complex wounds closest to the point of injury significantly improves Solider outcomes in prolonged care and reduces morbidity and mortality for severely injured. Rapid diagnostics (<2 hours sample collection-to-result) located at the point of battlefield injury will reduce time-to-result by 2-3 days (at minimum). Rapid turnaround of test results directly improves patient outcomes and return to duty by enabling earlier and accurate treatment decisions and/or surgical interventions, especially in large-scale combat operations where medical evacuation may be degraded. And where evacuation is available, the most critical may be evacuated earlier to a higher role of care to receive advanced medical intervention that is not otherwise available in far-forward environments.

However, simple-to-use capabilities that can accurately detect fungal and bacterial diseases in complex wounds has been challenged by the lack of effective sample collection and processing methods that can manage tissue and viscous fluids. Current market analysis has shown that rapid diagnostic capabilities lack the ability to conduct tissue homogenization procedures that are critical for isolation and accurate detection of bacterial and fungal species that are found in combat wounds.

 

The technology is not limited to but should consider, the factors below:

  1. The technology must include a plan for FDA clearance.

  2. Technology should have the ability to collect and process a clinical sample from a combat wound that can be used on a diagnostic platform capable of distinguishing between common clinical fungal and bacterial agents of infection with no downstream analysis required.

  3. Technology solutions overall should require minimum logistical support, should be compatible with applications in wet/dry environments, and stable in long term storage including hot (~100℃) and cold temperature (-20℃).

  4. Ease of use, technology should be operable with little training or background with unambiguous primary output.

 

Please Note - Technologies with the following features are not the primary focus of this topic:

  1. Wound swabs (cotton-based or other similar swab applications)

 

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. Completed Phase I efforts should demonstrate a promising design with demonstrated performance (i.e. improved sample collection/processing to result time (less than 2 hours) and decreased logistical burden) superior to current standards (i.e. traditional microbiology and culture procedures) in the laboratory. Completed Phase I efforts should include the development of a study plan that includes identification of at least one traditional microbiology and/or culture procedure to use as a comparator along with the proposed sample collection method and/or procedure; the intended goal of having a comparator is to determine if the proposed sample collection method and/or procedure performs better than current standard methods/procedures and results in a superior test sample readout.

 

PHASE II: During this phase, the lead candidate sample collection method and/or procedure should further refine proof-of- feasibility and proof-of-concept to integration with a rapid diagnostic technology that can detect fungal and bacterial agents from samples to provide a positive/negative result (in less than 2 hours). Proof-of-feasibility and proof-of-concept studies should address the challenge of sample collection from combat wounds and sample processing to support rapid diagnostic capability requirements. Proposals may include early versions of sample collection methods and procedures. Sample collection methods and/or procedures developed should demonstrate feasibility of sample isolation and detection of bacterial and fungal agents (common to combat wounds) that can be integrated with relevant rapid diagnostic platforms. The rapid diagnostic technology should not require any downstream diagnostic requirements (i.e. a medical doctor/physician to interpret and/or read test result(s)); result output should be a definitive positive or negative readout for each bacterial or fungal target. Animal and/or tissue infection model(s) should be considered as a means of tissue collection for subsequent sample processing method(s) for detection of several bacterial and fungal agents. The sample collection method and/or procedure should preferably align with CLIA-waived complexity standards (not to exceed moderate complexity) to support use in a far-forward environment by individuals with minimal microbiology training. At this stage, offers may begin developing a quality control plan. The offeror shall propose a regulatory strategy and provide a plan on how FDA clearance may be obtained (this does not include consultation or engagement with the FDA). Sample processing and/or procedures should be drafted in a multimedia format that can translate into commercialization of the product into the market. Efforts must be made to ensure that the sample collection method and/or procedure is affordable and aligns with current market value.

 

At the end of phase II, a proof-of-concept prototype should be defined; however, the government is not requiring an initial production lot of the prototype sample collection and processing method technology to be provided at this time. The sample collection and processing method prototype should be defined to a point that enables/facilitates a future Phase III award that includes prototype scale up in preparation for clinical evaluation.

 

PHASE III DUAL USE APPLICATIONS: The goal of this phase is to secure an FDA approved sample collection method/procedure that is compatible/integrated with a rapid diagnostic capability that is either in development or is already FDA-cleared enabling early detection of fungal and bacterial infection in combat wounds. Further development, testing and clinical evaluation of the sample collection method and/or procedure integrated with a rapid diagnostic technology in Phase II of this SBIR may be supported by BARDA, CDMRP, JWMRP, and other DOD opportunities. Once developed and demonstrated, the technology can be used commercially in both civilian and military settings to save lives. Market evidence supports use of the described capability in any civilian hospital where wound infection diagnostics are routinely performed. Wound cultures are a common and indispensable practice for diabetic chronic wound management, surgical site infections, and other circumstances involving persistent or severe infections. Similarly, Service Members are exposed to various organisms when deployed and suffer combat injuries that result in complicated wounds. If the sample collection method and/or procedure is transitioned into an Acquisition Program of Record, the Government may propose to the company to harmonize the technology design with other relevant products to meet additional DoD requirements.

 

REFERENCES:

Tribble DR, Ganesan A, Rodriguez CJ. Combat trauma-related invasive fungal wound infections. Curr Fungal Infect Rep. 2020 Jun;14(2):186-196. doi: 10.1007/s12281-020-00385-4. Epub 2020 Apr 16. PMID: 32665807; PMCID: PMC7360332.
Tribble DR, Murray CK, Lloyd BA, Ganesan A, Mende K, Blyth DM, Petfield JL, McDonald J. After the Battlefield: Infectious Complications among Wounded Warriors in the Trauma Infectious Disease Outcomes Study. Mil Med. 2019 Nov 1;184(Suppl 2):18-25. doi: 10.1093/milmed/usz027. PMID: 31778199; PMCID: PMC6886670.
Eardley WG, Brown KV, Bonner TJ, Green AD, Clasper JC. Infection in conflict wounded. Philos Trans R Soc Lond B Biol Sci. 2011 Jan 27;366(1562):204-18. doi: 10.1098/rstb.2010.0225. PMID: 21149356; PMCID: PMC3013428.
Murray CK, Roop SA, Hospenthal DR, Dooley DP, Wenner K, Hammock J, Taufen N, Gourdine E. Bacteriology of war wounds at the time of injury. Mil Med. 2006 Sep;171(9):826-9. doi: 10.7205/milmed.171.9.826. PMID: 17036599.

 

KEYWORDS: Sample collection, Infection(s), Fungal infection(s), Bacterial infection(s), Combat/Battlefield wound(s), Diagnostic(s), Clinical, Trauma