REQUEST FOR PROJECT PROPOSALS: “PRIMER AND PROBE MANUFACTURING PLATFORM (PROMPT)”

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 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.

• 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 synthesizing panels of relevant oligonucleotide sequences in a controlled environment.

To view the full-length version of this RPP, please visit, https://mtec-sc.org/solicitations/prompt-rpp

Proposers Conference

MTEC intends to host a Proposers Conference that will be conducted via virtual webinar on Wednesday, July 8th at 2PM EST. The intent of the Proposers Conference is to provide an administrative overview of this RPP process to award and present further insight into the Technical Requirements outlined in Section 3 of this RPP. To register for this conference, please use the following link:

https://events.gov.teams.microsoft.us/event/36cf8b7c-e796-4707-b437-7736163c038e@83251a03-76a5-4450-8bd6-55962891f972

TEAMING

While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to proposal submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government.

MTEC’s new website features a new functionality to assist members in team building. MTEC’s New Member Profiles can help Offerors identify potential teaming partners among other MTEC members, including innovators, and service providers. It can be accessed via www.mtec-sc.org/members.

MTEC also intends to hold a Teaming Connect for this effort on Tuesday, July 14 at 2pm EST. This will be a virtual “connect” session via webinar to help the membership collaborate and partner in relation to specific focus areas listed in the RPP. Organizations that are interested in speaking at this teaming connect and will be allotted three (3) minutes to pitch accompanied by a (1) slide. To register for this conference, please use the following link:

https://events.gov.teams.microsoft.us/event/2718df0f-65a5-482f-bce6-71e8bd5efb38@83251a03-76a5-4450-8bd6-55962891f972

Points of Contact

For inquiries, please direct your correspondence to the following contacts:

• Technical and membership questions should be directed to the MTEC Senior Technical Program Manager, Dr. Chuck Hutti, Ph.D., chuck.hutti@mtec-sc.org.
• All other questions should be directed to the MTEC Program Manager, Mr. Daniel Vala, daniel.vala@mtec-sc.org

To view the full-length version of this RPP, please visit, https://mtec-sc.org/solicitations/prompt-rpp