Request for Project Proposals: “PRimer and prObe Manufacturing PlaTform…

This solicitation, issued by the MTEC Consortium, represents a Request for Project Proposals (RPP) for MTEC in support of the Defense Threat Reduction Agency (DTRA). Military relevance is a critical component of the Solution Brief submission. Strategic oversight for the award(s) supported by this RPP will be provided by the Joint Science and Technology Office. This RPP is focused 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. Funding Availability:  The U.S. Government (USG) encourages Offerors to propose budgets commensurate with the nature, scope and complexity of the proposed research. Offerors should submit budgets that include the entire Period of Performance (PoP) of the research project. Yearly budgets should include all direct and indirect costs, based on supportable, verifiable estimates. Offerors are encouraged to scope out their budgets in alignment with major deliverables of their proposed work so that large budgets are easier to evaluate, and Sponsors can more easily allocate available funding. Number of anticipated awards:  MTEC expects to make  one or more award(s)  to a qualified Offeror to accomplish the scope of work. If a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner. See the “MTEC Member Teaming” section below for more details. Period of performance:  The PoP is not to exceed  24 months . To view the full-length version of this RPP, please visit, https://mtec-sc.org/solicitations/prompt-rpp Scope of Work Background Technology development and progress is 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. Objective The primary objective is to develop, integrate, and demonstrate 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. Solution Requirements The USG 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 lea