MTEC Pre-Announcement: “PRimer and prObe Manufacturing PlaTform (PROMPT)”

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) in support of the Defense Threat Reduction Agency (DTRA).  This effort focuses on the development of a fully automated, man-portable, and ruggedized prototype platform for the on-demand, expeditionary manufacturing of clinical-quality nucleic acid primers and probes. This system must be designed for operation in far forward or austere environments by non-specialist personnel. Background : Technology development and progress are urgently needed to address critical capability gaps in expeditionary medical diagnostics. Current diagnostic capabilities are hindered by a reliance on centralized manufacturing for essential nucleic acid amplification test (NAAT) reagents, such as primers and probes. This paradigm is currently incompatible with the demands of agile, far-forward medical responses to novel biothreats. An effective prototype must overcome several key challenges identified across the current landscape. Technologically, it must replace the current hazardous and environmentally sensitive synthesis systems with field-stable chemistry and ruggedized hardware. Any proposed system must integrate a deployable, effective method for both the purification of synthesized reagents and their subsequent quality control and validation, as this represents a major unsolved problem. Finally, any successful prototype must be developed with a clear strategy to navigate the currently undefined regulatory pathway for far-forward manufactured diagnostics. Technical Objective : This upcoming RPP focuses on the development, integration, and demonstration of a fully automated, man-portable, and ruggedized prototype platform for the on-demand, expeditionary manufacturing of clinical-quality nucleic acid primers and probes. This system must be designed for operation in far forward or austere environments by non-specialist personnel. The capability will specifically address critical technology gaps by replacing traditional, hazardous synthesis chemistry with a field-stable alternative and, most critically, integrating novel, on-board capabilities for both the automated purification and quality control validation of the resulting reagents. The successful outcome will be a self-contained system capable of producing sequence-verified, high-purity oligonucleotides from a digital sequence file within hours, thereby enabling a rapid, decentralized diagnostic response to novel biothreats without reliance on traditional laboratory infrastructure or cold chain logistics. Requirements : The U.S. Government is seeking solutions capable of satisfying the following capabilities: Integrate nucleic acid synthesis of Polymerase Chain Reaction (PCR) primers and probes, their basic purification, and first line quality control into compact, ruggedized instruments optimized for reduced size, weight, and power, and operable by minimally trained personnel at forward roles of care.  The instrument should be designed to meet MIL-STD-810 testing requirements (temperature, humidity, shock, vibration) and have reduced power draw for battery operations. Minimize logistical requirements for synthesis in inert environments through miniaturization, cartridges, or gas generation in situ . Provide high coupling efficiency oligonucleotide synthesis suitable for at least 20–40 nucleotide (nt) PCR primers and fluorescent probes, using chemistries (phosphoramidite and/or enzymatic) that can be operated safely in low-resource/field condition environments. Reagents must demonstrate stability at room temperature (20–25°C) for at least 12 months and function reliably across –20°C to 55°C without cold-chain dependence, utilizing approaches such as on-demand phosphoramidite synthesis, lyophilized formulations, or engineered enzymatic systems with enhanced thermostability. This should include the use of reagent, solvent, and cartridge designs that minimize the cold chain dependence, flammable solvent volumes, and hazardous materials. Improve oligonucleotide production time and yield to enable production of higher concentrations and volumes, ideally generating multiple high-quality nucleic acid-based molecular assay reagents per synthesis run to support rapid development of laboratory-developed tests (LDTs). Provide purification and verification approaches, such as cartridge-based cleanup and microfluidic electrophoresis, which are comparable to gold standard methods (HPLC, LCMS) in higher resource laboratories. Demonstrate end-to-end workflows through pilot projects that replicate a commercial PCR assay, comparing field-manufactured primers/probes to Good Manufacturing Practices (GMP) equivalents in terms of purity, analytical performance, and diagnostic accuracy. Prototypes must be provided for independent evaluation by government-identified laboratories, where the prototypes will synthesize panels of