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Robust Biochemical and Biomarker Rapid Detection and Assay System for Field Use

Description:

TECHNOLOGY AREA(S): Bio Medical 

OBJECTIVE: Devise and develop a rugged diagnostic platform for general biochemical and biomarker analysis, which can be used under prolonged field conditions and in isolated, austere environments. 

DESCRIPTION: Warfare can occur in isolated, austere environments with limited medical care at hand, precious treatment supplies, and no sophisticated diagnostics to guide treatment. Future operations are planning for more prolonged field care [1], as rapid evacuation may be impossible. Moving peripheral blood, saliva, or urine based diagnostic testing to the battlefield requires not only sensitive and rapid test results from a simple objective measurement or a simple set of multiplexed measurements, but also a test system consisting of a physical sensor/reader, chemical reagents, and specimen sampling means that can withstand harsh and prolonged environmental conditions. Such a system does not now exist. A useful system must be light weight, reliable, easy to use, yield results rapidly that are easy to interpret, and have direct bearing on preservation of life, health and function of warfighters. A recent report concerning deployment of diagnostic tests to near-patient settings in the rural developing world provides guidance [2]. Biochemical and biomarker systems are of critical importance to diagnosing the incidence, severity, and progression under treatment of wounded warrior status in prolonged field care conditions. Organ and metabolic status, infection, and traumatic brain injury are examples. Some specific biomarkers are the subject of past and possibly pending small business topics [3]. This topic is focused on the development of a platform that can perform multiple measurements, and potentially become a standard. A potential approach to the objectives of this topic could involve functionalized nanoparticles [4]. However, any approach to a battlefield biochemical and biomarker diagnostic system will be considered if it includes the following characteristics: 1. System sensitivity “ Wide biomarker concentration dynamic range from 1.0 micromolar to 0.1 picomolar 2. Rapid “ Less than 5 minutes from the opening of a test pack to obtaining one or more samples, and generating results. 3. Objectivity “ Automatic calibration. No operator interpretation needed. 4. Potential for Multiplexing “ An array of diagnostic data should be obtainable from a single sample, rather than multiple sampling for multiple tests. Detection of data should be seamlessly integrated with its analysis. 5. High-level, easily interpreted diagnostic output “ Possibility of machine learning guided interpretation of simultaneous test results, and trend analysis from serial test results. 

PHASE I: The overall aim of this phase is to develop, test, and demonstrate feasibility of a novel approach that meets the above criteria. Demonstrate at a proof-of-principle level the desired sensitivity, speed, objectivity, stability, and shelf life of the assay and testing system. Demonstrate proof of concept by demonstrating at least one diagnostic test that meet the criteria. Show feasibility by design and/or prototype construction of utility by minimally skilled users in an austere environment. Compare the proposed novel approach with existing standard diagnostic assays in the demonstration system. 

PHASE II: Construct and demonstrate the operation of a prototype battlefield-ready assay and testing system that meets the above criteria. The term battlefield-ready specifically includes small size, light weight, portable, and able to withstand the harsh conditions of temperature, humidity, water immersion, dirty environment, and physical abuse that are found in far forward environments. Discussions with the FDA should start in this phase to facilitate regulatory approval when ready. Discussions should include material and process documentation, and verifiable data sets on human samples. The U. S. Army Medical Materiel Development Activity, Division of Regulated Activities & Compliance (USAMMDA/DRAC [5]) is a potential source of regulatory assistance. 

PHASE III: In phase III pivotal clinical studies in military, and civilian medicine shall be completed. The prototypes demonstrated in phase II will be developed into Good Manufacturing Practice (GMP) products manufactured either by the small business or under license. FDA approval will be obtained for the validation of the platform and tests conducted with it, and for the GMP compliant processes to produce them as well as post-market data surveillance. The commercialized product will be of great value for the military when prolonged field care is necessary and/or in isolated, austere environments. It will also be of great value in civilian medicine in resource limited areas, such as remote areas, potentially in third world countries. The product could become an important research tool for studying the dynamics of biomarkers in healthy and impaired individuals. It could also potentially replace some more sophisticated laboratory tests owing to its speed, simplicity, and low cost. 

REFERENCES: 

1: Joint Program Committee 6/ Combat Casualty Care Research Program Prolonged Field Care Research Award Funding Opportunity Number: W81XWH-16-DMRDP-CCCRP-PFCRA, http://cdmrp.army.mil/funding/pa/16dmrdpcccrppfcra_pa.pdf

2: Dittrich S, Tadesse BT, Moussy F, Chua A, Zorzet A, Tängdén T, et al. (2016) Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus. PLoS ONE 11(8): e0161721. doi:10.1371/journal.pone.0161721

3: Liu X, Dai Q, Austin L, et al. (2008) A One-Step Homogeneous Immunoassay for Cancer. Biomarker Detection Using Gold Nanoparticle Probes Coupled with Dynamic Light Scattering. Journal of the American Chemical Society: 130:2780-2

4: http://mrmc.amedd.army.mil/index.cfm?pageid=medical_r_and_d.regulated_activities.overview

 

KEYWORDS: Prolonged Field Care, Austere Environment, Biomarkers, Rapid Diagnostic Tests, Developing World Medical Diagnostics, Activated Nanoparticles 

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