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Infectious Disease Diagnostics and Differentiation of Viral vs. Bacterial Infections for Point of Care Applications

TECHNOLOGY AREA(S): Chemical/Biological Defense; Biomedical OBJECTIVE: To provide an easy to use human clinical diagnostic testing technology which is effective for the detection, identification and differentiation of a wide range of viral and bacterial diseases caused by endemic diseases and biological warfare agents. Capabilities sought should be rapid and highly sensitive and selective solutions with low logistic burden for use in clinics and forward deployed military medical treatment facilities. DESCRIPTION: The U.S. Department of Defense requires infectious disease in vitro diagnostic (IVD) capabilities that are operationally suitable for use in far forward military environments and operationally effective versus a wide range of threats. Current single use disposable Lateral Flow Immunoassay-based diagnostic tests have many desirable operational suitability characteristics (low cost, minimal training, lightweight, results in 15 minutes, eye readable results, and long shelf life at room temperature) but lack sufficient sensitivity to be clinically useful for most infectious diseases. Current nucleic acid amplification-based diagnostic tests provide adequate sensitivity for many diseases but are slow (>30 minutes), more complex, and have a high cost per test. Lastly, current approaches to detect and identify specific diseases on an individual disease basis do not provide adequate breadth of coverage to fully inform treatment and patient evacuation decisions at the far forward, tactical level of health care on the battlefield. A combination of approaches to individually or syndromically identify diseases for the most common endemic diseases for the deployed military population paired with broad category screening approaches (such as virus vs. bacteria) that would address non-prevalent diseases (such as diseases caused by most Biological Warfare Agents) would provide an informative, yet risk balanced approach to support individual patient treatment, troop evacuation to higher echelon treatment facility/return to duty decisions, and public health decision making.To be affordable and supportable within the military healthcare system, diagnostic platforms must possess a broad range of capabilities for routine health care and endemic disease diagnostics while being a suitable platform for contingency use of Biological Warfare Agent and emerging disease IVD tests. For this reason, devices or companies with an existing catalog of FDA cleared tests for the U.S. domestic healthcare market and/or syndromic approaches to diagnostics are desired. Additionally, it is desirable for small business offerors to possess established quality management systems and regulatory affairs experience.This topic seeks to develop novel approaches to provide practical patient diagnostics and screening capabilities at field deployment locations from least-invasive clinical sample types while maintaining desirable operational suitability characteristics. PHASE I: Conduct proof of concept demonstrations of the specific technical approaches for disease diagnostics and screening (i.e., viral vs. bacterial infection differentiation) in symptomatic patients with high specificity (greater than or equal to 90%) for acute infections (testing occurs within the first 24 hours after symptom on-set) in an operationally suitable platform.Use of human or animal subjects is not intended, or expected, in order to establish/achieve the necessary proof-ofconcept.The Government will provide a list of diseases and etiological agents of operational concern (Government Furnished Information (GFI)) to inform the Contractor?s development of a technical approach. The primary emphasis will be for undifferentiated febrile illnesses. A subset is provided below for proposal development purposes:InfluenzaPneumonic PlagueDengueEndemic typhusScrub typhusLeptospirosisChikungunyaLassa FeverCrimean-Congo Hemorrhagic FeverThe description of the technical approach entails a detailed description of assay designs (bio-recognition elements), signal amplification and transduction techniques, selected sample type, and sample preparation techniques (if any) for a specific diagnostic intended and the description of a proposed clinical trial design and the performers ability to complete product development an achieve FDA regulatory approval within 3-5 years. The description should describe how sufficient inclusivity and specificity will be obtained to inform treatment and/or reflex testing decisions. A phased approach to expanding the inclusivity and intended use over time will be acceptable. Provide an analysis of the envisioned technical approach with respect to the Clinical Laboratory Improvement Act (CLIA) guidelines for CLIA-waived status. PHASE II: Develop and deliver prototype IVD device and pilot lot assays (if applicable to the system design) to the Government for independent evaluation. Complete pre-submission meetings with the FDA to inform inclusivity, specificity and syndromic approaches for the test and CLIA-waived clinical trial design. The degree of innovation will be measured by the offeror?s ability to achieve a high clinical specificity for a broad range of disease while retaining operationally desirable characteristics (cost < $40 per sample analyzed, training time less than 4 hours, system weight with consumables for 40 tests less than 25 lbs., single sample time to result less than 30 minutes, eye readable results, and consumable shelf life greater than 1 year at 25C).By the end of Phase II, the offeror will have produced a pre-production prototype of the diagnostic device, optimized the assay design for performance in the relevant clinical sample types, temperature and shelf life stability, and manufacturability and will be ready to begin pre-clinical trials shortly after Phase III award. PHASE III: Complete the maturation of all hardware, software and reagent elements of the diagnostic device. Conduct pre-clinical and clinical trials and 510(k) package preparation and submission (as the sponsor) to the U.S. Food and Drug Administration (FDA) for the initial IVD product developed under Phase II. Conduct follow-on developments and FDA clearances of IVD tests for additional known and emerging diseases of operational interest to the U.S. Military. Manufacture IVD devices and assays (as applicable to the technical approach) under current Good Manufacturing Practices (cGMP) and other quality systems and deliver to the Government for operational use by Warfighters. The Government will provide Government Furnished Information (GFI) and Materials (GFM), when not publically available, to support assay design and testing. The Government will provide access to Biological Safety Level (BSL) 3 and 4 testing facilities when needed. PHASE III DUAL USE APPLICATIONS: Beyond the diagnostic use for the military population, products of this effort are intended be used in U.S. and European Union domestic health care markets for in vitro diagnostics. Furthermore, for some disease tests, the products of this effort may be useful for companion diagnostics to be used in therapeutic development studies.  KEYWORDS: infectious disease, in vitro diagnostic, point of care, biological warfare agent, biomarkers  POINTS OF CONTACT: Dr. Brandi Vann, Phone: (703) 767-6045, Email: brandi.vann@dtra.mil; Mr. Adam Becker, Phone: (240) 409-7596, Email: adam.j.becker3.civ@mail.mil

  • Agency: Office for Chemical and Biological Defense,Department of Defense,Department of Defense
  • Program: STTR
  • Phase: Phase I
  • Release Date: August 27, 2015
  • Open Date: September 28, 2015
  • Close Date: October 28, 2015
  • URL: https://sbir.defensebusiness.org/topics
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