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Fast-Track proposals will be accepted. Direct-to-Phase II proposals will be accepted Number of anticipated awards: 3-5 Budget (total costs, per award): Phase I: up to $400,000 for up to 12 months Phase II: up to $2,000,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary Hepatitis C virus (HCV) causes both acute and chronic hepatitis, liver cirrhosis, and is a major cause of liver cancer. An estimated 71 million people worldwide have chronic HCV infection and approximately 400,000 people die annually from HCV-related cirrhosis and liver cancer. In the US, approximately 2.4 million people are currently living with HCV and the last decade has seen a 5-fold increase in new HCV infections primarily due to increases in intravenous injections of opioids. The greatest increases in new HCV infections has been in people aged 20-39 years. Highly effective and increasingly affordable direct-acting antiviral (DAA) therapies are now available. Currently, HCV can be diagnosed with a blood test and is curable. The CDC estimated that 50,300 acute hepatitis C cases occurred in 2018 but only 3,621 were reported to them due to under-ascertainment and under-reporting. In 2020, the US Preventive Services Task Force (USPSTF) recommended HCV screening for people aged 18-79 years, which expands on the previous USPSTF recommendation of HCV screening born between 1945 and 1965. The current screening modality includes screening for anti-HCV antibody serology testing followed by reverse transcriptase-polymerase chain reaction (RT-PCR) testing for HCV RNA and is accurate for identifying patients with chronic HCV infection. Given the large size of the target population for HCV screening, including populations who cannot or will not undergo clinic-based screening and marginalized high-risk populations, new strategies are needed to increase access and democratize HCV screening. A non-invasive, accurate screening test for HCV exposure or infection would allow initial screening to occur in non-clinical settings including at-home testing. A rapid test for anti-HCV antibodies is FDA approved but not for home use. A recent meta-analysis reported that oral specimens used with current anti-HCV antibody serology tests, including a rapid test, are almost as sensitive for anti-HCV antibodies as using blood. None of these tests have been optimized for use of oral specimens and only one is a rapid test. The development of a rapid and accurate at-home test for HCV antibodies for HCV exposure or HCV antigens or RNA for active HCV infection will provide a readily acceptable and accessible modality that can eventually reduce the burden of liver disease and HCC cancer morbidity and mortality. Project Goals The purpose of this solicitation is to develop and validate a rapid, sample-to-answer, point-of-care test for HCV exposure or Page 88 active infection that has the following required specifications: 1) can be used as a self-test in non-clinical settings including at home; 2) testing requires only the use of non-invasive specimens that can be safely collected at home such as (but not limited to) blood via finger prick, oral samples (e.g., saliva or buccal cells collections), or urine; and 3) achieves the same analytic performance as predicate tests that use blood for the detection of anti-HCV antibodies as a measure of exposure or HCV RNA or proteins as a measure of active infection. Activities not responsive to announcement: HCV diagnostics that do not meet the specifications in the Project Goals will be considered non-responsive. For example, tests that cannot be used at the point-of-care or as a self-test in the home setting will be considered non-responsive. Phase I Activities and Deliverables: Offers must propose to conduct activities that lead to development of a working prototype device ready for clinical evaluation, including but not limited to: • Develop a working diagnostic assay and/or prototype point-of-care diagnostic device that can identify people exposed to or have an infection by HCV using oral salivary specimens, urine, or sample of blood that can be collected using a lancet (i.e., specimens that can self-collected). • Demonstrate that the prototype diagnostic assay can be operated as a self-test by the target population. • Determine the sensitivity, specificity, and other performance characteristics (e.g. limit of detection, cross reactivity with other infectious agents, reproducibility, feasibility for newly infected, chronically infected, and resolved infected clinical samples, test stability) of the diagnostic test for HCV. • Conduct initial testing using samples from animal models and/or preferably on patient isolates to demonstrate feasibility. • 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 the partnering organization(s) in the proposal. Phase II Activities and Deliverables: • Develop a well-defined test platform under good laboratory practices (GLP) and/or good manufacturing practices (GMP). • Perform scale-up and production for multi-site evaluations (with at least one independent CLIA-certified laboratory) using clinical isolates. • Demonstrate suitability and operability of the test for use in non-clinical laboratory settings including self-test (with self-collection of the specimen) at home by target population. • Establish a product development strategy for FDA regulatory approval (as appropriate).
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