Background

Infection rates of hepatitis C virus (HCV) in the USA have steadily risen since 2010. There are approximately 2 million people infected with HCV in the USA with up to 140,000 new infections occurring annually. Globally, there are an estimated 71 million people living with HCV and it is estimated that as many as 50% may be unaware of their infection.

The World Health Organization’s (WHO) goals for eliminating HCV infection by 2030 will require better case identification/diagnosis and linkage to care. A point-of-care diagnostic that is accurate, simple, rapid, and affordable will greatly increase the diagnoses of HCV infections and link those infected to care. The current process to diagnose an active infection with HCV requires at least two tests and can take up to a week for results. An initial point-of-care screen for HCV antibodies in blood is followed, if positive, 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. One-step testing for active HCV infections utilizing a point-of-care assay would allow patients to receive their result in a single visit and allow for rapid care planning and management.

Research Objectives

The purpose of this Notice is to announce that the National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Biomedical Imaging and Bioengineering (NIBIB) are encouraging new applications to support translational research and development of rapid point-of-care diagnostics that will diagnose active viremic HCV infections. Applicants are encouraged to consult the target product profile for HCV diagnostics published by Reipold et al., BMC Infectious Diseases 2017, 17(Suppl 1):707. DOI 10.1186/s12879-017-2770-5, https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-017-2770-5 for additional preferred assay qualities and characteristics.

NOTE: The following application types will be considered non-responsive and will not be reviewed:

• Applications proposing serological assays that solely detect antibodies against HCV;
• Applications that do not have the ultimate goal of detecting and identifying an active viremic HCV infection in human clinical samples; and
• Applications lacking proof-of-concept data for proposed diagnostic platforms/technologies.

Application and Submission Information

This notice applies to due dates on or after January 5, 2020 and subsequent receipt dates through January 8, 2023.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs):

• PA-19-272 - PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-19-270 - PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed
• PA-19-053 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-19-056 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

For funding consideration, applicants must include NOT-AI-20-013 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

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