Description:
048 Non-Invasive Rapid Diagnostics for Respiratory Diseases in Children
Fast-Track proposals will be accepted.
Direct to Phase II proposals will be accepted.
Number of anticipated awards: 2-3
Budget (total costs):
Phase I: $225,000 for up to one year
Phase II: $1,500,000 for up to 3 years
Background:
Lower respiratory tract infections and pneumonias cause a significant burden of disease and mortality, particularly in children under the age of five. There is a need for simple tools to diagnose lung infections in children. Current clinical diagnostic methods for respiratory diseases typically take days-to-weeks, and may require multiple samples obtained by invasive methods. Sputum or bronchoalveolar lavage are the most common clinical specimens obtained for current diagnostic tests; however, most children and many adults are unable to produce sputum. Sputum induction and lavage sampling are highly invasive processes, causing discomfort to the patient and often resulting in unreliable sampling of potential pathogens. As a result, information from current diagnostics and specimens could be complicated by the presence of colonizing bacteria that are non-pathogenic and may not adequately define the underlying disease state. Non-invasive rapid diagnostic approaches are needed to enable a more timely and meaningful diagnosis and allow the patient to receive appropriate treatment before disease becomes severe. Potential benefits of non-invasive rapid diagnostics for lower respiratory tract infections include, but are not limited to:
• Improved patient compliance and willingness to seek early medical treatment
• Reduced risk of exacerbating disease due to diagnostic procedures
• Ability to monitor the patient’s infectious status over time, and to monitor success of treatment
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Project Goal:
The goal of this project is to develop rapid, sensitive diagnostics for lower respiratory tract infections (of bacterial, viral, and/or fungal origin) that would be suitable for children and utilize non-invasive specimen collection methods. Examples of non-invasive specimen types may include, but are not limited to analytes in exhaled breath, saliva, oral swabs, and bodily secretions (urine, tears, and sweat). The proposed diagnostic device (and associated components) should be simple to use, compatible with point-of-care use by healthcare personnel, employ reagents that can be stored under ambient conditions, and be compatible with U.S. regulatory guidelines for testing and validation. Utilization of appropriately consented, de-identified human-derived material in preclinical studies in support of compliance with regulatory requirements is permitted and encouraged. Additional human-derived sample collection is allowed under this solicitation.
Phase I activities can include but are not limited to:
• Development of an approach for the identification and examination of analytes associated with lower respiratory tract infections caused by a specific pathogen(s).
• Development of a prototype device to demonstrate its feasibility for pathogen detection.
• Determination of the sensitivity, specificity and other performance characteristics (e.g. time to result, limit of detection, test stability) of the product.
Phase II activities can include but are not limited to:
• Evaluation of the ability of diagnostic device to distinguish different types of respiratory infections (e.g. of bacterial, viral, and/or fungal origin).
• Assessment of the utility of the device to distinguish between bacterial colonization and active infection.
• In preclinical disease models, evaluation of changes in analyte pattern after antibiotic administration.
• Conduct of additional validation studies with de-identified human specimens to identify factors that may influence or confound the diagnostic result.
• Product development strategy for regulatory approval and demonstration of clinical utility.
This SBIR will not support:
• The design and conduct of clinical trials (see http://www.niaid.nih.gov/researchfunding/glossary/pages/c.aspx#clintrial for the NIH definition of a clinical trial). For clinical trial support, please refer to the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement or the NIAID Investigator-Initiated Clinical Trial Resources webpage.
• Validation testing that would be reported back to the patient or the treating physician.
• The development of technologies that rely solely on nucleic acid amplification followed by a hybridization detection step for detection of a pathogen-specific antigen or a host-response antibody.
• The development of diagnostics requiring culture-bottle and/or streak plate incubations.
• Proposals that do not have the ultimate goal of detection and identification of pathogens in human clinical samples.
• The development of environmental or workplace pathogen/toxin detection technologies.
• The development of diagnostics for HIV.
