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. Keywords: Expeditionary, Far-Forward, Diagnostics, Rapid Assay Development, Point-of-Need, Nucleic Acid Synthesizer, Manufacturing, Stability, Molecular Assay, Laboratory-Developed Test