SAM #MTEC-27-PROMPT

Prototype Platform for On-Demand Manufacturing of Nucleic Acid Primers and Probes (Pre-Announcement)

The Army Medical Research Acquisition Activity (ARMY MED RES ACQ ACTIVITY), under the Defense Health Agency (DHA) and supporting the Defense Threat Reduction Agency (DTRA), is preparing to solicit proposals for a next-generation, portable nucleic acid primer and probe manufacturing platform. - Government Buyer: - Army Medical Research Acquisition Activity (ARMY MED RES ACQ ACTIVITY) - Under Defense Health Agency (DHA) and Defense Threat Reduction Agency (DTRA) - Products/Services Requested: - Development, integration, and demonstration of a fully automated, man-portable, ruggedized prototype system for on-demand manufacturing of clinical-quality nucleic acid primers and probes - System must integrate nucleic acid synthesis, purification, and quality control in a compact instrument - Designed for use by non-specialist personnel in austere or far-forward environments - Unique/Notable Requirements: - Prototype must meet MIL-STD-810 military ruggedization standards - Must use field-stable chemistries, minimizing cold chain and hazardous material dependencies - Output quality must be comparable to laboratory-synthesized oligonucleotides - MTEC membership is required to submit proposals - No specific OEMs or vendors are named in the announcement - Period of performance is up to 24 months - Place of performance and contracting office at Fort Detrick, Maryland

Description

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 relevant oligonucleotide sequences in a controlled environment.

Potential Funding Availability and Period of Performance:

The Government currently anticipates making one or more awards to a qualified Offeror(s) for a period of performance not to exceed 24 months. Offerors will be encouraged to propose budgets commensurate with the current stage of development and anticipated scope for the project.

Acquisition Approach:

This upcoming RPP is expected to utilize a two-stage approach (solution brief and pitch) where interested offerors will submit solution briefs in response to this effort. The Government will evaluate solution briefs submitted and will select those that best meet its current technology priorities using the criteria noted in the upcoming RPP. Those selected will be invited to participate in a pitch event with the government sponsor for final selection of award(s).

The upcoming RPP will be posted to the MTEC website (mtec-sc.org) and a summary version will be available on SAM.gov to notify interested parties. The RPP is expected to be released as soon as possible and will have a proposal preparation period of approximately 30 days. MTEC membership is required for the submission of a proposal in response to the upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/.

MTEC:

The MTEC mission is to assist the Department of Defense (DoD) U.S. Army Medical Research and Development Command (USAMRDC), the Defense Health Agency (DHA), and other Government agencies by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the Defense Health Agency Contracting Activity (DHACA).

For more information on the MTEC mission, see the MTEC website at mtec-sc.org.

Point of Contact:

For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Chuck Hutti, MTEC Senior Technical Program Manager, chuck.hutti@mtec-sc.org.

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