Key Dates

Related Announcements

PA-20-185- NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
PA-22-176- PHS 2022-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
PA-22-178- PHS 2022-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Cancer Institute (NCI)

Purpose

Background

Infection rates of hepatitis C virus (HCV) in the United States of America (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 one 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 of Special Interest is to announce that the National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Cancer Institute (NCI) are encouraging applications in the area of 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 (https://doi.org/10.1186/s12879-017-2770-5) for additional preferred assay qualities and characteristics. In addition, the NCI has special interest in developing Point-of-Care testing for HCV diagnosis that will lead to further assessment of the liver damage, stage of fibrosis/cirrhosis and ultimately the risk for liver cancer.

Applications Not Responsive to this NOSI

The following types of studies are not responsive to this NOSI:

• 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.
• Applications lacking proof-of-concept data for proposed diagnostic platforms/technologies.

Application and Submission Information

Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.

In addition, applicants using NIH Parent announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

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-23-001” (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.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Julie Dyall, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:301-631-7296
Email: [email protected]

Jo Ann Rinaudo, PhD
National Cancer Institute (NCI)
Telephone: 240-276-7133
Email: [email protected]

Tiffani Lash, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: [email protected]