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Chapter 4 - Contribution of RADx® Tech to the Rapid Development of COVID-19 Diagnostic Tests

Published online by Cambridge University Press:  06 January 2024

By
Steven C. Schachter ,
John M. Collins ,
Michael K. Dempsey ,
Laura L. Gibson ,
Matthew L. Robinson  and
Paul Tessier
Edited by
Steven C. Schachter  and
Wade E. Bolton
Steven C. Schachter
Affiliation:
Harvard Medical School
Wade E. Bolton
Affiliation:
VentureWell/Rapid Acceleration of Diagnostics (RADx)
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Summary

Rapid Acceleration of Diagnostics (RADx®) Tech was the key diagnostics component of a three-pronged national strategy, including vaccines and therapeutics, to respond to the COVID-19 pandemic. Unprecedented in the scale of its mission, its budget, its accelerated time frame, the extent of cross-government agency collaboration and information exchange, and the blending of business, academic, and investment best practices, RAD Tech successfully launched dozens of US Food and Drug Administration Emergency Use Authorization diagnostic tests, established a new model for rapidly translating diagnostic tests from the laboratory to the marketplace, and accelerated public acceptance of home-based diagnostic tests. This chapter provides an overview of the processes utilized by RADx Tech during the COVID-19 pandemic to improve clinical laboratory tests and identify, evaluate, support, validate, and commercialize innovative point-of-care and home-based tests that directly detected the presence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus.

Keywords

Rapid Acceleration of Diagnostic (RADx)diagnostic testsCOVID-19deep divetranslational researchEmergency Use Authorizationproject screening funnelRADx process
Type
Chapter
Information
Accelerating Diagnostics in a Time of Crisis
The Response to COVID-19 and a Roadmap for Future Pandemics
 , pp. 74 - 87
Publisher: Cambridge University Press
Print publication year: 2024

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References

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