Shelf-Stable Nucleic Acid Synthesis Reagents for Field-Deployable Diagnostics

OBJECTIVE
Develop novel, shelf-stable reagents for nucleic acid synthesizers that enable the creation of high-quality oligonucleotides for rapid diagnostic test (RDT) development at the point of need in 30 days in a far-forward, expeditionary environment
DESCRIPTION
The Chemical and Biological Defense Program (CBDP) faces a critical challenge: the need for rapid, deployable diagnostic capabilities in far forward or expeditionary environments. Maintaining the health and readiness of the total force hinges on the ability to rapidly develop and deploy diagnostic assays in response to emerging threats and infectious diseases. However, current technologies present significant limitations. Existing nucleic acid synthesizers rely on reagents that demand cold chain storage at 4 C and possess limited shelf lives. These requirements render them impractical for use in resource-constrained or remote locations, hindering the rapid development and deployment of laboratory-developed tests (LDTs) precisely where they are most needed at the point of need. To overcome these obstacles, there is an urgent requirement for nucleic acid synthesis reagents exhibiting exceptional stability. These reagents must remain effective at room temperature, perform reliably across a broad range of military operationally relevant conditions, from -20 C to 55 C, and maintain an extended shelf life of at least 12 months, all while performing at a level equal to or exceeding existing reagents. Beyond stability and shelf life, the CBDP is interested in developing reagents that significantly improve the yield of synthesized nucleic acids. This enhanced yield would enable the production of oligonucleotides with higher concentrations and volumes, ideally suited for generating multiple high-quality nucleic acid based molecular assay reagents per synthesis run.
PHASE I
The objective of Phase I is to demonstrate the feasibility of producing nucleic acid synthesis reagents with enhanced stability and shelf life. This will involve developing and testing prototype reagents that meet or exceed the performance of current standard reagents of nucleic acid synthesizers. The prototype reagents should demonstrate stability at room temperature (20-25 C) for an extended amount of time prior to use, function in the device outside of the normal operating temperature range and maintaining equivalent performance to standard reagents. Success will be measured by comparing the performance of the novel reagents with standard reagents in synthesizing a control oligonucleotide sequence, assessing yield and purity using standard analytical techniques (e.g., High-Performance Liquid Chromatography (HPLC), mass spectrometry).
PHASE II
Phase II will focus on optimizing the formulation and manufacturing process for the shelf-stable reagents, scaling up production, and conducting comprehensive stability testing. The deliverable will be a pre-production prototype kit of reagents suitable for use in a commercially available nucleic acid synthesizer. The reagents should demonstrate stability at room temperature (20-25 C) for at least 12 months, function in the device outside of the normal operating temperature range and maintain equivalent performance to standard reagents. The prototype kit will be evaluated by a government identified independent laboratory to assess its performance in synthesizing a panel of relevant oligonucleotide sequences for nucleic acid based molecular assay reagents.
PHASE III DUAL USE APPLICATIONS
PHASE III: Phase III will focus on transitioning the technology to commercial production and distribution. This will involve securing partnerships with reagent manufacturers and diagnostic companies, obtaining regulatory approvals (if necessary), and developing a comprehensive marketing and sales strategy. Further optimization of the reagent formulation and packaging may be required to meet specific customer needs and market demands. The ultimate goal is to develop reagents that perform reliably across a broad range of military operationally relevant conditions, from -20 C to 55 C, and maintain an extended shelf life of at least 12 months, all while performing at a level equal to or exceeding existing reagents, enabling the rapid development and deployment of diagnostic assays in far-forward and expeditionary environments.
PHASE III DUAL USE APPLICATIONS: Beyond DoD applications, these reagents can be used by commercial diagnostic companies, academic research labs, and public health organizations for rapid assay development and deployment in resource-limited settings.
REFERENCES
Swierczewski B, Simons M. Diagnostics in a Forward Deployed Setting. Mil Med. 2017 Sep.,182(S2):11-16. doi: 10.7205/MILMED-D-17-00069. PMID: 28885919.
Yeh KB, Wood H, Scullion M, Russell JA, Parker K, Gnade BT, Jones AR, Whittier C, Mereish K. Molecular Detection of Biological Agents in the Field: Then and Now. mSphere. 2019 Dec 11.,4(6):e00695-19. doi: 10.1128/mSphere.00695-19. PMID: 31826970., PMCID: PMC6908421.
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