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NIBIB is building on the success of the Rapid Acceleration of Diagnostics Technology (RADx® Tech) program and Independent Test Assessment Program (ITAP) to address a range of respiratory diseases and other health challenges. With an established infrastructure, these programs can be utilized to quickly develop, validate, and achieve regulatory authorization of technologies.
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.
Global Health Infectious Diseases Men's Health Point of Care Sexually Transmitted Diseases (STD) Women's Health New projects - there are no open funding opportunities. Check back for new announcements. Ongoing projects - submissions are no longer being accepted
The Blueprint MedTech Incubator Hub opportunity is a two-stage, milestone-driven opportunity for innovators developing medical devices aimed at preventing, diagnosing, or treating disorders of the nervous system. Learn more.
Blueprint MedTech: Funding Opportunity for Groundbreaking Medtech Devices https://blueprintneurotech.org/?utm_source=HubsDirect&utm_campaign=BPMTc6launch&utm_medium=web
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.
ITAP for Multiplex POC and OTC Diagnostics for COVID-19 and Flu Learn more
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.
RADx Tech ITAP for Hepatitis B Virus POC Test Learn more https://www.cimit.org/radx-tech-itap-for-hepatitis-b-virus-surface-antigen
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
Learn more https://www.cimit.org/radx-tech-act-endo
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
Blueprint MedTech: Funding Opportunity for Neurotech Innovations Learn more https://blueprintneurotech.org/
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.
FDA press release Cepheid Xpert HCV
RADx Tech ITAP for Hepatitis C Virus (HCV) RNA Point-of-Care (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.
Advanced Platforms for HIV Viral Load Monitoring at the Point-of-Care Learn more
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.
ITAP for Point-of-Care Lesion Panel Tests Learn more 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.
Read about the winning projects
Learn more about this project
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.
Learn more about this project
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:
Labcorp PCR test home collection kit
This project is supporting development of point-of-care tests to measure viral load to monitor treatment and infectiousness.
Learn more about this project
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
Learn more about this project mHealth Point of Care Technologies - Diagnostics