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Rapid, Point-of-Care Diagnostics for Hepatitis C Virus

Description:

Fast-Track proposals will be accepted. Direct-to-Phase II proposals will not be accepted. Number of anticipated awards: 2-3 Budget (total costs): Phase I: $300,000 for up to one year; Phase II: $1,500,000 for up to 3 years. Background Infection rates of hepatitis C virus (HCV) in the USA have steadily risen since 2010. There are approximately 2 million people chronically infected with HCV in the USA, and it is estimated that up to 45,000 acute infections occur annually. Spontaneous clearance of HCV occurs in 15-47% of acutely infected individuals; the remaining will develop chronic HCV (defined as viremic for 6 months or greater). Globally, there are an estimated 71 million people with chronic HCV; it is estimated that as many as 50% may be unaware of their infection. In 2016, the World Health Organization established a goal for eliminating HCV infection as a major public health threat by 2030, defined by reductions in incidence (by 90%) and mortality (by 65%). In order to achieve these goals, a new point-of- care (POC) diagnostic that is sensitive, specific, simple, rapid, and cost-effective is critical to more readily connect infected individuals with treatment and case management efforts. While the current HCV diagnostic process utilizes assays that are highly sensitive and specific, it requires at least two tests that can take up to a week or more for results. An initial positive point-of-care screen for anti-HCV antibodies in blood is followed by a viral load test performed in a centralized laboratory. Either the same sample is reflex tested, or the patient must supply an additional sample. The delay in diagnosis can have a significant impact on follow-up care, initiation of treatment, and potential transmission of the virus in at-risk groups (such as persons who inject drugs). Simplified POC testing for active, viremic HCV infections would allow patients to receive their result in a single visit and allow for rapid care planning and management with their physician. Project Goal The purpose of this solicitation is to develop a POC diagnostic for primary health-care settings to detect active, viremic HCV infections in a single visit and to confirm cure following treatment. The diagnostic should be rapid (e.g. results ideally in 1 hour or less), simple (require minimal equipment or training to perform), cost-effective, and have the same or better sensitivity and specificity characteristics as similar FDA-approved diagnostic tests currently available for HCV. Additionally, the diagnostic should be able to detect all HCV genotypes, exhibit no cross-reactivity with endogenous substances or exogenous factors, and ideally utilize sample types that are minimally invasive (such as capillary whole blood). Offerors may need to establish a collaboration or partnership with a medical facility or research group in the US that can provide relevant positive control and patient samples; offerors must provide a letter of support from any partnering organization(s) in the proposal. Phase 1 activities may include, but are not limited to: • Identification of appropriate diagnostic targets (antigen, biomarkers, nucleic acid sequences, etc.) for a POC diagnostic to detect active, viremic HCV infections. • Development of the prototype POC diagnostic platform (lateral flow system, instrument, etc.) to detect active, viremic HCV infections. • Determination and/or optimization of the sensitivity, specificity and other performance characteristics (e.g. time to result, limit of detection, test stability) of the prototype POC diagnostic. • Initial testing using clinical laboratory isolates with multiple genotypes. • Initial testing using HCV clinical samples or matrices spiked with known quantities of HCV. Phase 2 activities may include, but are not limited to: • Further characterization of diagnostic targets for the POC diagnostic to detect active, viremic HCV infections. • Advanced development of the prototype POC diagnostic platform to detect active, viremic HCV infections. • Optimization of the sensitivity, specificity, and other performance characteristics (e.g. time to result, limit of detection, test stability). • Validation of assay reproducibility. • Testing clinical samples from diverse cohorts with varying infecting genotypes and varying case history (acute or chronic). • GMP manufacturing of test components and final validation studies. 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). • Proposals that are focused on serological assays that solely detect antibodies against HCV. • Proposals that do not have the ultimate goal of detecting and identifying an active, viremic HCV infection in human clinical samples.
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