The DHS Directorate of Science and Technology (S&T) is seeking performers for clinical assay development against high priority pathogens.
The effort supports the Chemical and Biological Defense Division (CBD) mission of the DHS S&T to reduce the probability and potential consequences of a biological pathogen or a chemical attack on the nation’s civilian population, its infrastructure, or its agricultural system.
Specific elements of the major task areas will include:
- Test and evaluation of in-house clinical assays specific for the detection of Ebola virus antigen, Bacillus anthracis antigen, and Burkholderia spp. Creation and characterization of novel monoclonal antibodies specifically recognizing these agents should already be completed to properly address this task.
- Demonstrated ability to support test, evaluation, and validation studies in the performer’s laboratories. This task will involve the laboratory testing of clinical samples and materials for the detection of the specific agents described.
- Ability to manufacture the assays using the in house reagents into lateral flow assays or suspension bead-based assay chemistries.
- Production of reagents and assembly of reagents for test kits to support test, evaluation, and validation studies.
- Ability to work with select agents for live testing to assess the functionality of each assay alone (Lateral Flow Assay (LFA)) and in combination with other agents in the case of bead-based assays should also be possible if the prototype assays are deemed to be functional.
- For Ebola virus, the use of analogues and recombinant alternatives will be judged on an individual basis. However, testing against live BSL-4 agent in clinical samples will be required later in the process; how this will be accomplished should be addressed somewhere in the proposal.
- Conduct appropriate studies to support reagent stability and test sample stability for test and evaluation studies.
- Development of IDA 510K package for FDA approval for in vitro diagnostics.
Although subject to official fiscal appropriation and availability, it is anticipated that approximately $900,000.00 of Fiscal Year 2015 funds will be available for any resultant awards under this BAA Call.
Further details are available via Solicitation Number: HSHQDC14RB00090BAA14003Call7. Responses are due March 31, 2015.