Beyond COVID Projects
NIBIB is building on the success of the Rapid Acceleration of Diagnostics Technology (RADx® Tech) program and Independent Test Assessment Program (ITAP) to meet the needs of health challenges beyond the COVID-19 pandemic. With an established infrastructure, these programs can be utilized to quickly develop, validate, and achieve regulatory authorization for a range of health care problems.
Several programs have been initiated using the RADx Tech innovation funnel and ITAP mechanisms to support development of at-home and point-of-care (POC) diagnostic and monitoring technologies.
Ongoing projects - submissions are no longer being accepted
ITAP for Point-of-Care Lesion Panel Tests
This solicitation aims to address the diagnostic needs for point-of-care (POC) lesion panel tests. This includes tests intended for the direct detection and differentiation of mpox virus (mpxv), herpes simplex virus types 1 and 2 (HSV1/2), Treponema pallidum (Syphilis), and varicella-zoster virus (VZV) in lesion swab specimens (lesion panel). NIBIB plans to support analytical and clinical testing to accelerate test validation and regulatory review of POC tests. These efforts will help facilitate rapid production and commercialization of mpox lesion panel tests in the US.
RADx Tech Fetal Monitoring Challenge
This Challenge will make multiple awards totaling up to $2 million to accelerate the development of fetal diagnostic and monitoring technologies. Successful technologies developed in this Challenge will directly measure one or more parameters of fetal health status during the late antepartum and/or intrapartum periods of pregnancy.
Blueprint MedTech
Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.
RADx Tech for Maternal Health Challenge
This Challenge will award up to $8 million in cash prizes for development of technologies to improve maternal health outcomes for those who live in areas lacking access to maternity care. Priorities are for home-based or point-of-care diagnostic devices, wearables and other remote sensing technologies to improve postpartum healthcare in these regions.
Advanced Platforms for HIV Viral Load Testing at the Point of Care
This project is supporting development of point-of-care tests to measure viral load to monitor treatment and infectiousness.
ITAP for Mpox
This program is addressing the diagnostic needs of mpox (formerly monkeypox). ITAP support will help accelerate the validation, regulatory authorization, and commercialization of point-of-care (POC) and home virus tests.
Authorized products:
ITAP for Hepatitis C Virus (HCV) RNA Point-of-Care (POC) Diagnostics
This project is supporting development of POC tests for the direct detection and quantitation of the hepatitis C virus RNA. ITAP will help accelerate the validation, regulatory authorization, and commercialization of select HCV RNA POC diagnostics.