Host-Based Diagnostics for Acute Infections

DISCLAIMER This is an information request only. This request is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Solicitations are not available currently. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. Purpose: Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE CBRND) invites you to collaborate with us in a critical mission: to develop the next generation of host-based assays for diagnosis of disease etiology, prognostication of clinical outcomes, and directed administration of therapeutic treatments that will protect the warfighter from chemical, biological, radiological, and nuclear (CBRN) threats. This RFI is your opportunity to help shape the future of military medicine and contribute directly to the readiness and resilience of our armed forces. The decade-long surge in tracking host responses to pathogens has spawned diagnostic technologies that utilize specific panels of host response molecules to differentially diagnose the class of pathogen (e.g., bacterial or viral), predict the likelihood of severe illness and/or enable the selection of therapeutic regimen. The goal is to identify and develop a new generation of host-based test to diagnose a warfighter’s condition, predict clinical outcomes, and direct the optimum therapeutics for maximal disease recovery. This creates a prime opportunity for innovative companies to align their research and development pipelines with a forward-looking program. Disclaimer: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government, nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issue because of this RFI Requested Information of Interest: CPE CBRND is conducting essential market research for the Advanced Differential Diagnostics (ADD) program, an existing Program of Record that is developing new diagnostic capabilities in a phased approach. This program is dedicated to identifying and advancing mature diagnostics that utilize the warfighter’s early response to the pathogen. CPE CBRN will be focused on developing and delivering diagnostics that help meet operational and mission needs across the conflict continuum. The goal is to create a resilient force, capable of withstanding, mitigating, and recovering from the complex injuries caused by CBRN threats, some of which are outlined in the Medical Management of Biologic Casualties Handbook,  Medical Consequences of Radiological and Nuclear Warfare, and  Medical Aspects of Chemical Warfare. We are seeking information from industry partners developing innovative solutions that diagnose infection based on measures of the body’s response rather than targeting specific pathogens. These tests will rely on host biomarkers to make diagnostic determinations, for example, peripheral blood cellular gene expression patterns, rather than direct detection of a pathogen. We are particularly interested in candidates that fall into the following categories: Predictive Diagnostics for Infection Complications: Diagnostic assays that are predictive for Sepsis, SIRS, respiratory destabilization, or other acute complications from infections of biowarfare agents, based on the patient’s current condition and measurable host biomarkers circulating in the peripheral blood or other easily accessible sample types. Diagnostics to assist in Therapeutic Selection and Monitoring: Diagnostics based on host biomarkers that enable precision medicine for the most appropriate treatment, or that reveal proper response to therapeutics or ineffective therapeutics, such as in hyperinflammatory states or immune response paralysis that may occur due to biowarfare agent exposure or other infectious agents.  We are seeking mature candidates (preference for diagnostics at Technology Readiness Level (TRL) 4 or higher) that align with the following ideal product profile: Example Target Product Profile for Host-Directed Products This profile targets products designed to enable rapid diagnostic decision-making in remote laboratories or central clinical laboratories for suspected acute infections that may also direct effective therapeutic treatments to prevent severe outcome and/or monitor recovery. Feature Desired Characteristic Intended Use: Used with clinical assessments and other laboratory findings as an aid to determine the likelihood of severe clinical outcome in adults with suspected acute infections; and/or enlighten the selection of appropriate therapeutics.  Device Size and Robustness: Since the device is intended for low resource sites, the ideal size should be relatively small (handheld or backpack-sized), battery-operable and/or externally powered, oper