RADx Pooling Task Force - POCTRN
In response to the COVID-19 pandemic, the Rapid Acceleration of Diagnostics (RADxsm) initiative was formed to accelerate the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect SARS-CoV-2, the virus that causes COVID-19.
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RADx Pooling Task Force: Pooling Overview, Key Development Challenges for Central Laboratories and Point of Care (POC) Solutions, Regulatory Guidance for Pooling, and Implementation Examples
Please join us for a multi-disciplinary RADx Pooling Task force has been created to engage with the FDA, CMS, and CDC to address pooling practices and guidance for the Central Laboratory and Point of Care (PoC) solutions. As an example, there are currently no EUA regulatory guidance documents for PoC pooling and no approved PoC Pooling solutions on the market. The presentation will focus on COVID-19 pooling including a high level overview of pooling, implementation challenges, regulatory requirements and solutions, and examples of pooling.
RADx Portfolio Executive
CIMIT Accelerator Executive
Radx Team Lead
Clair O'Donovan, PhD
RADx Team Lead
Erika A. Tyburski
RADx Regulatory Core
Director of Operations, Atlanta Center for Microsystems Engineered Point of Care Technologies (ACME POCT)
Ethan Burke MD, MP
Chief Public Health Officer UnitedHealth Group
June 15, 2021