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.
New projects - submissions are being accepted
In partnership with the FDA, NIBIB's RADx Tech program is soliciting proposals to accelerate the validation, 510(k) submission, and commercialization of innovative point-of-care (POC) and over-the-counter (OTC) multiplex tests that can detect at-minimum COVID-19, Flu A and Flu B. Tests that include additional respiratory targets (e.g., H5N1, RSV) are encouraged. Applications are due no later than April 17, 2025 by 11:59PM ET.
Ongoing projects - submissions are no longer being accepted
The RADx® Tech Independent Test Assessment Program (ITAP) is soliciting proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC) tests for hepatitis B virus surface antigen (HBsAg) detection.
ITAP will consider applications from test manufacturers with existing technologies, at or near design lock, that can quickly enter production and can meet the FDA's performance/quality standards for marketing authorization.
This initiative aims to accelerate the development of innovative technologies for diagnosing endometriosis. Endometriosis, a chronic condition affecting approximately 1 in 10 reproductive-aged women worldwide, urgently requires better diagnostic tools. Up to $3 million in prizes.
March 13, 2025, news release: NIH announces finalists of endometriosis diagnostics competition
This program is seeking collaborative projects aimed at developing emerging technologies into commercially viable, clinically focused solutions for disorders of the nervous system that are aligned with the mission and interests of the participating NIH institutes and centers.
View a recorded webinar for more information: Watch webinar
RADx Tech ITAP for Hepatitis C Virus (HCV) RNA Point-of-Care (POC) Diagnostics
This project supported authorization of a POC test for the direct detection and quantitation of the hepatitis C virus RNA. The ITAP accelerated the validation, regulatory authorization, and commercialization of select HCV RNA POC diagnostics.
This project is soliciting proposals to accelerate the commercialization of innovative point-of-care HIV viral load testing platforms that facilitate monitoring antiretroviral therapy (ART) effectiveness and accurately assess potential for transmission.
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.
Completed projects
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 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.
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:
This project is supporting development of point-of-care tests to measure viral load to monitor treatment and infectiousness.
In this Challenge, NIH awarded 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. NIH placed priority on home-based or point-of-care diagnostic devices, wearables and other remote sensing technologies to improve postpartum healthcare in these regions.
Oct. 15, 2024, news release: NIH announces winners of prize competition to improve postpartum maternal health and health equity through innovative diagnostics