The Defense Threat Reduction Agency (DTRA) Research and Development Enterprise Chemical and Biological Technologies Directorate (RD-CB) continues the effort towards development of a simple to use field diagnostic device with current Request for Information (RFI) numbered DTRA-12-CBA-0002.
The agency seeks details on existing devices or technologies that upon successful completion could be used in the diagnosis of diseases whose cause is an infectious agent or toxin. Such a device should be “low resource and low complexity,” and be FDA approved or compatible with FDA clearance. These devices should follow appropriate FDA regulations as well as the Clinical Laboratory Improvement Amendment (CLIA)-waiver designations.
The RFI is specifically directed at collecting information on the following two use cases:
(1) Highly robust self-collection and presumptive diagnostic screening modality (analogous to home glucose testing), medical diagnostic devices demonstrating CLIA-waived status/low complexity, for use in austere environments and capable of entry to “telemedicine” electronic treatment hierarchy and defined reflexivity to higher level of care. Such a device should demonstrate sufficient analytical sensitivity and negative predictive value for infectious disease screening applications.
(2) Handheld and CLIA-waived diagnostic devices that are designed for diagnostic or confirmatory field use by a medically trained operator in a “primary care” setting (i.e., field clinic, urgent care facility, Level 1 Medical Treatment Facility, Shock Trauma Platoon, etc.). Such a device should demonstrate sufficient analytical sensitivity, specificity and total (positive and negative) predictive value for infectious disease diagnostic and confirmatory applications.
In both cases, information is 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 (organized as panels by syndromic presentation or pathogen class), and/or biomarkers of exposure to said agents. Analytes of interest include both pathogen and pathogen class-differential diagnostic markers.
DTRA RD-CB Joint Science and Technology Office (JSTO) is leading the scientific and technology effort for the Department of Defense CB programs through basic and applied research and experimental development related to chemical and biological threat agent characterization, medical diagnostic methods and medical pre-treatment and therapeutic countermeasures, and physical decontamination, detection, protection, and decision support capabilities.
The RFI is open to the in-vitro diagnostic and biotechnology industry, academic, research institute, national or military laboratories sources. The response deadline is March 28, 2012.