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In Vitro Affinity-Based Diagnostic System for Diseases Resulting from CBRN Exposure

Biodefense RFI Market Research

The Medical Countermeasure Systems – Joint Product Lead for Diagnostics (MCS-DX) is conducting research to inform future investments in diagnostics to complement current and planned polymerase chain reaction (PCR)-based capabilities.

Technologies should enable clinically-relevant diagnosis of chemical, biological, or radiological (CBR) warfare agent intoxication or infection at early points in disease progression. Of additional interest are systems that leverage or integrate with routine, non-CBR, healthcare capabilities to favor broader adoption across the services and enhance force readiness.

MCS-DX is responsible for the development, acquisition, and sustainment of FDA-cleared diagnostic devices intended for use by Service Members in the diagnosis, prevention, and treatment of exposure to CBR agents. Currently, MCS-DX is fielding a molecular assay (PCR) system for diagnosis of infection with a limited set of biological threats. However, there are instances where the molecular pathology of disease suggests PCR is not an effective methodology. Such a situation may arise with biological threats early in infection or with organisms that become compartmentalized and sequestered (e.g. in abscesses of internal organs) from easily accessible sample types. MCS-DX desires information regarding systems, and their components, that may address those instances.

Traditional and non-traditional defense contractors, including companies new to working with the DoD, are encouraged to respond. Companies currently in the U.S. domestic healthcare market, or considering entry into the FDA-cleared diagnostics market, are especially encouraged to respond. Respondents are invited to provide information related to their capabilities to fulfill any portion of the requirements listed below. Companies with an enabling technology that may serve as a component within a diagnostic system (e.g. clinical sample collection and preservation, sample preparation, assay designs, etc.) are encouraged to respond.

Capabilities developed and fielded by MCS-DX are intended for use by a variety of U.S. personnel in a range of deployed locations. A combat medic or physician assistant on the frontline may need to perform diagnostics in a fairly uncontrolled environment, such as a Battalion Aid Station tent. Further from the frontline, yet still “in theatre”, a dedicated laboratory technician of a 50-bed combat support hospital may need to perform diagnostics of all levels of complexity in a controlled operational environment, not unlike many Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories.

Service Members are evacuated through this combat health support system depending on severity of illness and assessed ability to return to duty. As such, clinical sampling and field diagnostic testing is likely to occur between 0 and 168 hours after acute symptom onset. Additionally, CBR diagnostics are used in parallel with, and are subservient to, routine combat casualty care (i.e., trauma and endemic disease medical countermeasures). Thus, it is highly desired for CBR diagnostic capabilities to leverage routine, non-CBR health care capabilities such as clinical chemistry tests, endemic infectious disease tests, traumatic brain injury screening, and specific or non-specific insult/injury host-response.

The Department of Defense (DoD) currently operates multiplex-PCR diagnostics in the controlled laboratory environment mentioned above and expects to deploy additional PCR-based, CBR diagnostic capabilities closer to the combat frontline by 2022. Any new capabilities must complement the existing diagnostics family of systems to improve patient health outcomes and force health decisions.

Requirements: The purpose of this RFI is to solicit information on the availability or developmental status of affinity-based systems, or other alternatives to polymerase chain reaction (PCR)-based systems, for diagnosis of intoxication or infection with CBR warfare agents. Responses will inform market research for the advanced development, procurement, fielding, and sustainment of a reusable, lightweight, low-complexity, in vitro diagnostic (IVD) capability.

MCS-DX is interested in a reusable, multiplex diagnostic platform with application to CBR threats including:

  • Diagnostic Targets: Agent-derived or host-response biomarkers are acceptable for each disease.
  • Clinical Sample Types: Non-invasive or minimally invasive sample types consistent with collection and analyses in austere environments (e.g., capillary whole blood, venous whole blood, saliva, urine, sputum, stool, exudates, etc.).
  • HIPAA-compliant communications and data processing tools supporting remote data analysis/interpretation of point-of-care sample analyses, if applicable, should be described.
  • Time to Result: Rapid sample-to-answer protocol is highly desired – if greater than 120 minutes, please explain why this is the state of the art for the threat/application. Rapid protocols support administration of appropriate clinical treatment at earlier points in disease progression.
  • Ease-of-Use: Moderate complexity to CLIA-waived – if highly complex please explain why this is the state of the art for the threat/application.
  • Product Maturity: FDA-cleared IVD or sufficiently mature to begin clinical trials no later than 2023.
  • Safety features for use with BSL 4 agents, including limited user exposure to contaminated sample and minimized risk of aerosolizing sample materials, are desirable.

Additional details are available via Solicitation Number: W911QY18S0007.

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