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Development of Field-Forward Diagnostic Technologies

The Naval Research Laboratory (NRL) is seeking research & development partners to advance in vitro diagnostic devices that are amenable to military hardening and integration with communication capabilities.

The effort supports enhanced biosurveillance capabilities of the US military in field-forward locations. Syndromic approaches on devices capable of detecting diseases that cause febrile illness are specifically sought.

Genomic Analysis Platforms

Devices are sought which are capable of examining molecular sequences, specifically DNA and/or RNA, to provide positive identification of the causative agent. Analysis should be multiplexed (minimum of three, preferred more than 4) to provide a syndromic approach to disease identification; including sub-classification for diseases as appropriate (e.g., serotypes 1, 2, 3, and 4 for dengue virus, differentiation of Ebola strains).

High Performance Immuno-Analysis Platforms

Devices capable of identification of immunological targets are also sought (TRL-4 or higher) that provide identification of the causative agent of febrile illness. Analysis should be multiplexed (minimum of three, preferred more than 4) to provide a syndromic approach to disease identification; including sub-classification for diseases as appropriate. Assays for immunological targets that indicate acute infections are preferred, particularly for deployment in endemic areas.

In either use case, the device and assay must have the following characteristics:

  • Low-complexity device requiring minimal training
  • Total sample to answer timeframe of one hour or less is preferred
  • For use in field forward, often austere environments with limited resource
  • Capable of running on battery power
  • Capable of entry to telemedicine/remote consultation electronic treatment hierarchy

Important assumptions for these environments include that they have no surgical or patient holding capability, are manned by a Physician, Physician Assistant (PA), or Medic, with the mission of providing triage, and treatment to return military personnel to duty, or stabilizing them for evacuation to the next level care facility.

Analytes of interest include both pathogen and pathogen class-differential diagnostic markers. The ability to differentiate between pathogens such as Malaria (specifically P. falciparum), Arboviral diseases (e.g. dengue, chikungunya, etc.), Typhoid, Arenaviral diseases, Rickettsial diseases, Viral hemorrhagic fevers (specifically Lassa fever), Plague, Tularemia (Francisella tularensis), and melioidosis (Burkholderia pseudomallei) is desirable.

NRL will work cooperatively with the Offeror to test and verify performance of the devices and to assist in the integration of the diagnostic devices with communication and device hardening for field application. The offeror must demonstrate manufacturing capability, or partnerships for manufacturing, that assure prototype Devices and Assays will be available for field deployment and testing at the end of the performance period.

Further details are available via Solicitation Number: N00173-15-R-BA01.

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