Book contents
- Accelerating Diagnostics in a Time of Crisis
- Accelerating Diagnostics in a Time of Crisis
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Preface
- Acknowledgments
- Introduction
- Chapter 1 Early Detection, Response, and Surveillance of the COVID-19 Pandemic Crisis
- Chapter 2 Immunology of COVID-19 and Ineffective Immunity
- Chapter 3 Clinical Management: A Roadmap Based on One New York City Hospital’s Response to the COVID-19 Pandemic
- Chapter 4 Contribution of RADx® Tech to the Rapid Development of COVID-19 Diagnostic Tests
- Chapter 5 Coordination of Resources for the Manufacturing and Deployment of COVID-19 Diagnostic Assays
- Chapter 6 Quality and Risk Management Processes for Diagnostic Assays during an Emergency Pandemic Response
- Chapter 7 Development of Assays to Diagnose COVID-19
- Chapter 8 Laboratory Verification and Clinical Validation of COVID-19 Diagnostic Assays
- Chapter 9 Importance of Timely Sequencing, Tracking, and Surveillance of Emergent Variants
- Chapter 10 The RADx® Regulatory Core and Its Role in COVID-19 Emergency Use Authorizations
- Chapter 11 Commercialization and Market Assessment of COVID-19 Assays
- Chapter 12 Testing Strategies to Mitigate COVID-19 Disease Spread
- Chapter 13 A Pandemic Not Just of Infection but of Inequality: The Social Impact of COVID-19
- Chapter 14 Summary and Path Forward for Future Pandemics
- Index
Chapter 5 - Coordination of Resources for the Manufacturing and Deployment of COVID-19 Diagnostic Assays
Published online by Cambridge University Press: 06 January 2024
- Accelerating Diagnostics in a Time of Crisis
- Accelerating Diagnostics in a Time of Crisis
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Preface
- Acknowledgments
- Introduction
- Chapter 1 Early Detection, Response, and Surveillance of the COVID-19 Pandemic Crisis
- Chapter 2 Immunology of COVID-19 and Ineffective Immunity
- Chapter 3 Clinical Management: A Roadmap Based on One New York City Hospital’s Response to the COVID-19 Pandemic
- Chapter 4 Contribution of RADx® Tech to the Rapid Development of COVID-19 Diagnostic Tests
- Chapter 5 Coordination of Resources for the Manufacturing and Deployment of COVID-19 Diagnostic Assays
- Chapter 6 Quality and Risk Management Processes for Diagnostic Assays during an Emergency Pandemic Response
- Chapter 7 Development of Assays to Diagnose COVID-19
- Chapter 8 Laboratory Verification and Clinical Validation of COVID-19 Diagnostic Assays
- Chapter 9 Importance of Timely Sequencing, Tracking, and Surveillance of Emergent Variants
- Chapter 10 The RADx® Regulatory Core and Its Role in COVID-19 Emergency Use Authorizations
- Chapter 11 Commercialization and Market Assessment of COVID-19 Assays
- Chapter 12 Testing Strategies to Mitigate COVID-19 Disease Spread
- Chapter 13 A Pandemic Not Just of Infection but of Inequality: The Social Impact of COVID-19
- Chapter 14 Summary and Path Forward for Future Pandemics
- Index
Summary
The Rapid Acceleration of Diagnostics (RADx®) program’s success would be significantly diminished without the support of the Deployment Core. For a company to successfully bring to market an in vitro diagnostic (IVD) test, it requires expertise in a variety of areas. This is especially pertinent in a pandemic landscape, as timelines are greatly reduced and market demand is constantly changing. Within the RADx initiative, the Deployment Core was established to identify and provide these necessary resources. The Deployment Core was formed in May 2020 after the IVD companies’ needs became apparent, including the need for consultant expertise and various resources to support development and scale up. This chapter explores the challenges faced by many RADx companies and the lessons learned through the Deployment Core in addressing those needs.
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- Accelerating Diagnostics in a Time of CrisisThe Response to COVID-19 and a Roadmap for Future Pandemics, pp. 88 - 102Publisher: Cambridge University PressPrint publication year: 2024