Accelerating Diagnostics in a Time of Crisis

Steven Schachter, MD is a Professor of Neurology at Harvard Medical School and Chief Academic Officer for CIMIT, Boston. As RADx Chief, Dr. Schachter led the design and implementation of the extramural aspects of the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development of technologies for COVID-19 testing. Wade Bolton, Ph.D. is Team Lead and Content Expert for VentureWell and works with the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development of technologies for COVID-19 testing. Previously, he was Divisional Vice President for Hematology Research and Development at Abbott Laboratories.

Introduction Tania Fernandez; 1. Early detection, response, and surveillance of the covid-19 pandemic crisis Enrique Rabellino, Alexandra Smith and Marta Cohen; 2. Immune system responses to SARS-CoV-2 Adolfo Firpo-Betancourt; 3. Clinical management: a roadmap for one nyc hospital's response to the covid-19 pandemic Barbara Barnett, Yvette Calderon, Erick Eiting, Young Lee, Lina Miyakawa, Waleed Javaid and Saralynne Brown; 4. Contribution of radx to the rapid development and commercialization of covid-19 diagnostic assays Steven Schachter, John Collins, Michael Dempsey, Laura Gibson, Matthew Robinson and Paul Tessier; 5. Coordination of resources for the deployment of covid-19 diagnostic assays Brian Walsh, Maren Downing, Mia Cirrincoine, Adam Samuta, Kevin Leite, Sam Dolphin, Emily Muth and Jose Valdesuso; 6. Quality and risk management processes for diagnostic assays during an emergency pandemic response  Devon Campbell and Christie Johnson; 7. Development of assays to diagnose covid-19 Yuka Manabe and William Clarke; 8. Laboratory verification and clinical validation of covid-19 diagnostic assays Wilbur Lam, Leda Bassit, Anuradha Rao, Jennifer Frediani and Julie Sullivan; 9. Importance of timely sequencing, tracking and surveillance of emergent variants Anne Piantadosi, Jessica Lin, Morgan Greenleaf, Leda Bassit, Cassandra Wesselman and Yang Lu; 10. The RADx regulatory core and its role in covid-19 emergency use authorizations Erika Tyburski and Cathy Cambria; 11. Commercialization and market assessment of covid-19 assays Manuel Kingsley, Sunshine Moore and Heath Naquin; 12. Testing strategies to mitigate covid-19 disease spread Paul Tessier and Peko Hosoi; 13. A pandemic not just of infection but of inequality: the social impact of covid-19 Mara Aspinall and Liz Ruark; 14. Summary and path forward for future pandemics Wade Bolton and Steven Schachter.