The Naval Research Laboratory has issued a Broad Agency Announcement (BAA) for advanced technology development of mature in vitro diagnostic devices that are amenable to military hardening and integration with communication capabilities to support the biosurveillance needs of the US military.
The Government is interested in proposals offering innovative approaches for in vitro diagnostics devices for the following two use cases:
1 – Highly robust self-collection and presumptive diagnostic screening medical diagnostic devices demonstrating low complexity, specifically for use in austere environments. Such a device should demonstrate sufficient analytical sensitivity for infectious disease screening applications. Such a device would require the capability to interface with telemedicine or remote consultation systems. No assumption should be made as to the mode of communication of the test result. The only requirement is that the communication of the resulting analytical data is possible via electronic means (e.g. voice, text message, email, image), and that the algorithm by which the diagnostic information is generated and provided to the patient and physician, be remote to the device itself.
2 – Handheld and CLIA-waived diagnostic devices that are more highly multiplexed and designed for diagnostic or confirmatory field use by a medically trained operator in a “primary care” setting such as a field clinic, urgent care facility, Level 1 Medical Treatment Facility or Shock Trauma Platoon. 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. Devices should demonstrate sufficient analytical sensitivity, specificity and total (positive and negative) predictive value for infectious disease diagnostic and confirmatory applications.
In both cases, proposals are sought for medical diagnostic devices that have been designed to deliver information that will be used to facilitate the diagnosis of diseases whose origin is an infectious agent pathogen or toxin, and/or biomarkers of exposure to said agents.
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 (VHF), Plague, Q fever (Coxiella burnetti), Tularemia (Francisella tularensis), and Anthrax (B. anthracis) is desirable.
It is not a requirement that the device technology be specifically designed for these pathogens, but it is preferable that the technology be adaptable to these agents. One specific matrix of interest is blood with either a finger prick or venous blood draw by a medic or trained medical personnel. It is not a requirement that the device technology be designed for a blood matrix but it is preferable that it be adaptable enough to enable diagnostics on a blood matrix.
NRL will work cooperatively with offerors 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 total amount of funding available for the effort is approximately $2M. The Government anticipates that award will be in the form of a cooperative agreement. Full details, including a major milestone timeline, are available under Solicitation Number: BAA-N00173-6101. The response deadline is May 23, 2012.
