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
- References
Chapter 11 - Commercialization and Market Assessment of COVID-19 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
- References
Summary
Commercialization is the process of bringing diagnostics from the laboratory setting to the commercial market. Rapid Acceleration of Diagnostics (RADx®) portfolio companies were tasked with developing and producing millions of rapid, accurate, low-cost, and convenient COVID-19 tests to meet surging demand, but tests only help if people can access them. Many would-be purchasers discovered that tests alone would not solve the problem – they needed comprehensive testing solutions. In this chapter, we discuss RADx’s role in assisting portfolio companies in understanding customers’ evolving needs; the shifting market dynamics with each new wave, vaccine, or variant; and the barriers and opportunities to market success. We highlight go-to-market strategies and policy decisions that worked well and we outline policy and regulatory barriers that hindered broader success. We reflect on the lessons learned and potential solutions to adopt before the next pandemic and in the broader context of the future diagnostic delivery system.
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- Accelerating Diagnostics in a Time of CrisisThe Response to COVID-19 and a Roadmap for Future Pandemics, pp. 211 - 235Publisher: Cambridge University PressPrint publication year: 2024