RFI – Diagnostic Devices for Biological, Chemical and Nuclear Threats

The Joint Project Management Medical Countermeasure Systems (JPM-MCS), as part of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), has issued a Request For Information (RFI) for the advanced development, procurement, fielding, and sustainment of medical treatment, prophylactic, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) warfare agents.

Information gathered in response to this RFI will be used to support the Joint Product Director for Diagnostics (JPdM Dx) in strategic planning for development of the Next Generation Diagnostics System Increment 2 (NGDS Inc 2) acquisition strategy. Specifically, information gathered will be reviewed as part of a market survey in support of the NGDS Inc 2 Request For Proposals (RFP) expected to be released by late summer/early Fall 2015.

JPM-MCS is interested in collecting information from companies who are currently in the U.S. domestic healthcare market or are considering a future entry into the market for FDA-cleared diagnostics for human diseases caused by exposure to biological, chemical, toxin, and radiological threat agents.

JPM-MCS is interested in collecting information about diagnostics systems that are complementary to, and to be used in conjunction with, the NGDS Inc 1 sample-to-answer molecular (PCR) diagnostic platform (Biofire FilmArray) used in forward-deployed clinical laboratories (i.e. combat support hospitals and ships).

The NGDS Inc 2 program is seeking information on affinity-based diagnostics systems or other alternatives to PCR-based diagnostics systems. A biomarker-based diagnostics approach is desirable where direct antigen detection is not feasible due to low concentrations of circulating threat agents in relevant clinical samples such as whole blood or sputum.

The NGDS Inc 2 program is interested in assay designs focusing on detection of host-response biomarkers, including serological assays, as indication of CBRN exposure. However, novel application of PCR-based technologies for CBRN diagnostics will be considered if not redundant to the NGDS Inc 1 system. Patients may be tested pre-symptomatically or within 12 to 120 hours of exhibiting symptoms, depending on the location of the clinic/laboratory.

CBRN threats that are of specific interest to the NGDS Inc 2 program include:

  • Intracellular bacterial pathogens: Brucella spp., Rickettsia spp., Coxiella burnetii
  • Burkholderia spp.
  • Biological toxins: Botulinum toxin, Ricin, SEB
  • Viruses: Alphavirus spp.
  • Chemical Warfare agents: Nerve agents, blood agents, choking agents
  • Radiological exposures

Further details are available via Solicitation Number: W911QY-15-S-0006. The response deadline is April 8, 2015.

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