Our Initiatives
RADx®: Rapid Acceleration of Diagnostics
About
Design and execute a medtech innovation program to rapidly develop and deliver billions of COVID–19 tests to market during the pandemic.
Overview
In 2020, shortly after receiving $1.5 billion from Congress to support the development of COVID-19 tests, the National Institutes of Health launched RADx® Tech with the goal of rapidly bringing to market point-of-care and home-based tests, as well as clinical laboratory tests, that could detect SARS-CoV-2.
In its capacity as coordinating center for the Point-of-Care Technologies Research Network (POCTRN), Cimit played a key leadership role in designing and implementing the RADx® Tech program. Cimit’s unique contributions included employing its expertise in rapid medtech product development, proven process, deep bench of experts, and tools to support project management and risk assessment throughout the RADx® Tech process.
Core Leads
Michael Dempsey
Subprojects Core Lead for CINTA; Entrepreneur-in-Residence, Consultant Innovator, Cimit
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Penny Ford-Carleton, RN, MS, MPA, MSC
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CINTA Staff
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
Challenge
When COVID–19 spread across the country in 2020, Americans did not know if it was safe to leave their home or go back to work or school. Point–of–care and at-home tests were needed to help mitigate the spread of the virus. Executing this challenge involved management of contributions from hundreds of experts at academic centers, companies, and nonprofits, as well as collaboration among a number of government agencies.
Impact
Due to the collective efforts of hundreds of individuals, companies, and academic centers, the program was a tremendous success.
- Applicant’s review time was reduced from the typical four to six months to 35 days.
- Fifty-five Emergency Use Authorizations were issued.
- The first round of diagnostic tests was brought to market within months.
- Nearly 8 billion tests were delivered within three years of the program launch.
- The first over-the-counter home test to receive FDA EUA.
This reduced timeline was unprecedented — given that most government-funded medtech initiatives take six to seven years to reach commercialization.
The RADx® Tech process is now being employed to advance at-home and point-of-care technologies for a wide range of conditions, including Mpox, hepatitis C virus RNA, Treponema Pallidum, varicella-zoster virus, and more.
Activities
- Cimit solicited applications for projects from a wide range of constituents including:
- academic organizations.
- private sector companies.
- solo researchers.
- In conjunction with NIH, Cimit designed an innovation funnel that moved applications and projects through multiple review gates that consistently pressure-tested ideas against technical, clinical, commercial, and regulatory criteria.
- Employing its CoLab platform, Cimit led the applicant review process, which was focused on “assessing, improving, and then selecting” projects to fast track the advancement of promising solutions.
- Projects that met criteria in the first review underwent a two-week in-depth analysis. Selected projects then entered a month-long process to validate the proposed ideas. If a project was deemed successful, rapid scale-up and clinical testing were undertaken with funding from the NIH. Tests were then manufactured and deployed.
- Cimit employed the Guidance and Impact Tracking System (GAITS) to provide each team with an innovation roadmap, guidance, and educational resources, as well as information on how well they were meeting milestones.
- Cimit’s extensive network of experts in science, medicine, engineering, and business played a critical role in the initiative, providing expertise in the applicant review process and consulting to teams throughout the health innovation process.
For more information on Cimit’s involvement in RADx® Tech, read the RADx® Tech story, IEEE articles, and book Accelerating Diagnostics in a Time of Crisis.
Reach out to learn more/start a conversation.