NIH RAPID ACCELERATION OF DIAGNOSTICS 

(RADX®) TECH| RADx® Tech

OVERVIEW: RADx Tech was created to generate a robust pipeline of innovative diagnostic technologies to 

increase national COVID-19 testing capacity. This effort was able to validate, de-risk, manufacture, scaleup, and deploy novel at-home and point-of-care tests through an optimized pipeline in less than eight 

months.

RADx Tech Innovation Funnel

This funnel was designed to compress the customary 

technology development timeline from years down to 

months

What People are Saying 

"The US RADx program has spawned 

a phalanx of diagnostic products to 

market in just 12 months. Its longterm impact on point-of-care, at-home 

and population testing maybe even more 

profound."

— Nature Biotechnology Editorial, April 2021

Independent Test Assessment Program (ITAP)

Accelerates regulatory review and availability of 

high-quality, accurate, and reliable diagnostic tests

• As a collaboration between RADx Tech and the 

FDA, ITAP support has produced 12 over-thecounter (OTC) Emergency Use Authorizations 

(EUAs) for COVID-19 diagnostic devices

• Current ITAP support focuses on validating 

multiplex diagnostic products for COVID-19 

and Flu

Mobile At Home Reporting Through Standards 

(MARS)

Promotes a standards-based approach to reporting 

COVID-19 self-test results and establishes best 

practices for future reporting of remote diagnostics

• MARS site currently supports reporting for 10 

COVID-19 diagnostic products

• Since launching in November 2022, over 

123,000 test results have been self-reported

• MARS acts as the backbone for Make My 

Test Count, a website to anonymously report 

test results regardless of the type of test, 

which can then be assessed by local public 

health departments

Accessible Test Initiative

The effort to work with collaborators to develop athome diagnostic tests for COVID-19 that can be used 

independently by people with disabilities

• Collaborated with the U.S. Access Board to 

develop a “Best Practices” document for the 

design of accessible, at-home tests

• The RADx Tech III funnel has recently funded 

five projects focused on developing accessible 

tests

• Achieved EUA for a simple, two-part, "pen" test 

that can be used independently by people with 

disabilities

Program Contacts: RADxInfo@nih.gov

www.nibib.nih.gov/covid-19/radxtech-program

Last updated as of October 31, 2023
NIH RAPID ACCELERATION OF DIAGNOSTICS 

(RADX®) UNDERSERVED POPULATIONS | RADx®-UP

OVERVIEW: The RADx-UP program assesses and expands COVID-19 testing to reduce disparities for 

underserved and vulnerable populations.

RADx-UP Program Highlights

• The program strengthened the ability to distribute 

millions of diagnostic tests within underserved 

populations and reach different communities 

disproportionately affected by COVID-19

• Projects provided isolation and contact tracing 

strategies, as well as point of care, self and salivabased testing to mitigate community transmission 

• Publications indicate that mitigation strategies, 

including testing, can reduce COVID-19 

transmission in settings such as schools, residential 

care facilities, and jails/prisons

• Community-engaged and directed research is 

integral to implementing testing and mitigation 

strategies, and requires time and attention to build 

trust, adequate compensation for community 

collaborators, and investment of full partnership 

among researchers, community participants, and 

NIH scientific staff

Community Engagement’s 

Impact 

• Community engagement accelerated program goals 

and advanced equitable access to testing locally and 

nationally.

• Trusted partnerships quickly mobilized interventions, 

while enhancing community acceptance and 

readiness for research.

• Underserved populations want to collect, share, and 

disseminate their data – it is a key piece of 

community engagement - they also want to hear 

about results!

RADxInfo@nih.gov | www.radx-up.org

RADx-UP Project Locations

Below is a map of the number of RADx-UP projects across the 

U.S. and Territories from Phase I through Phase IV

What Participants are Saying

“The idea here is to partner

with communities and local

health departments to help

address inequities, beginning

with inequities in testing, and the

vast majority of these funds will go

into these counties and directly into these at-risk 

communities.”

– Edward Ellerbeck, M.D., MPH

RADx-UP Principal Investigator

Chair, Department of Population Health

University of Kansas School of Medicine

Last updated as of November 29, 2023
NIH RAPID ACCELERATION OF DIAGNOSTICS 

(RADX®) RADICAL (RAD)| RADx®-RAD

OVERVIEW: The NIH’s RADx-rad program supports new, non-traditional approaches that address current 

gaps in COVID-19 testing and surveillance, such as rapid detection devices, environmental surveillance and 

diagnosis of acute and long-term effects of COVID-19. These approaches may improve identification and 

tracking of SARS-CoV-2, as well as future pathogens, and provide information on acute and long-term 

effects of COVID-19.

Program Highlights

• 49 Extramural Awards issued to 45 unique

institutions in 20 states; also supported two

intramural projects

• Beyond initial awards, ran a challenge prize which

attracted 160 participants and resulted in six awards

Example Research Technologies:

• Optimization and clinical validation of novel and

repurposed technologies, such as chemosensory

approaches and exosome-based detection

technology for SARS-CoV-2 detection

• Approaches to using wastewater-based and other 

environmental analysis for SARS-CoV-2 detection, 

to provide real time information and forewarning 

of disease spread

• Development of prognostic algorithms to stratify

multisystem inflammatory syndrome in children

(MIS-C) and severe SARS-CoV-2 in children

• Support of a Computational Challenge for creative

data-driven solutions to advance the current

understanding of the risks of developing Long

COVID

RADx-rad Project Locations 

U.S. Distribution of Institutions awarded in Phase I

Research Focus Areas

What People are Saying

“These awards from the RADx-rad 

program provide superb examples of 

outside-the-box concepts that will 

help us overcome this pandemic and 

give us a cadre of devices and tactics to 

confront future outbreaks.”

– Former NIH Director Francis S. Collins,

M.D., Ph.D.

Program Contact: RADxInfo@nih.gov

www.nih.gov/research-training/medical-researchinitiatives/radx/radx-programs#radx-rad

Last updated as of November 2, 2023
NIH RAPID ACCELERATION OF DIAGNOSTICS 

(RADX®) DATA HUB| RADx® Data Hub

OVERVIEW: The RADx Data Hub is a cloud-enabled data repository that provides curated and deidentified COVID-19 study data, algorithms, and other capabilities generated by the NIH-supported 

RADx programs. It supports capabilities to find, aggregate, and analyze data to better understand 

COVID-19 and future pandemics including underserved populations and those disproportionately 

impacted by COVID-19.

Program Goals

1. Develop a cloud-based data repository of

COVID-19 research data – including clinical,

behavioral, social determinants of health,

survey, interview, diagnostic test results, viral

sequencing, output from smart sensors, selfreported symptoms, and imaging data

2. Provide access to de-identified RADx study

research data, algorithms, and other

capabilities to expand testing and identify

effective testing implementation strategies,

especially for underserved populations and

those disproportionately impacted by

COVID-19

RADx Data Hub Data Sources

The data collection of the participants in RADx Data Hub 

are spread across the country with many 

states represented by multiple RADx programs.

Program Accomplishments

The RADx Data Hub:

• Provides a secure workspace to combine

authorized data use and analytics tools

• Enables researcher collaborations

• Ensures ability to share analyses results

• Created a framework for generating artificial

intelligence-ready datasets

• Creation of a RADx Tribal Data Repository for

sovereignty-based data access and sharing of

American Indian/Alaska Native RADx data

RADx Data Hub Architecture

What People are Saying 

“This marks a major milestone for the RADx 

Initiative...from our DHP partnership’s efforts, the 

support of our colleagues across the NIH Institutes, 

Centers, and Offices who have committed countless 

hours to the RADx effort, research participants, and 

the tireless efforts of the RADx researchers across 

the nation.” — Dr. Susan Gregurick, Director, 

Associate Director for Data Science, NIH

Program Contacts: Lucy Hsu: lucy.hsu@nih.gov

Updated as of December 12, 2023