RADx Pooling Task Force - POCTRN

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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. 

Presenters

Wolfgang Krull 
RADx Portfolio Executive
CIMIT Accelerator Executive

Pam Miller 
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 

When
June 15, 2021 
2PM ET

Watch the recording >

RADx: Rapid Acceleration of Diagnostics

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.

ABOUT RADx

In the News 

Two New Over-the-Counter At-Home COVID-19 Tests Brought to U.S. Market Quickly by Biden-Harris Administration

New HHS actions add to Biden administration efforts to increase access to easy-to-use over-the-counter COVID-19 tests

NIH RADx initiative expands COVID-19 testing innovation for additional types of rapid tests

The need for new test verification and regulatory support for innovative diagnostics

NIH-funded screening study builds case for frequent COVID-19 antigen testing

RADx partnerships speed new COVID testing

One Year of RADx Tech Success

Publication reveals essential ingredients of the groundbreaking NIH RADx national diagnostics effort 

Innovative COVID-19 Testing RADx Tech Reports Unveiled in Special Issue of IEEE Open Journal of Engineering in Medicine and Biology

Luminostics Announces FDA Authorization and Production Scale-Up of US-Manufactured Smartphone-Based COVID-19 Rapid Test

RADx Expects COVID-19 Portfolio to Accelerate an Era of At-Home Infectious Disease Testing (Login Required)

VIC Foundry, Inc. Receives NIH RADx Funding for Development of an At-home Molecular Diagnostic Test for COVID-19

Ceres Nanosciences Opens Advanced Particle Manufacturing Plant in Northern Virginia to Expand Nanotrap® Particle Manufacturing Capacity for COVID-19 Testing

COVID-19 Testing: Three Breakthrough Solutions in the RADx Initiative

NIH Director: Collaboration Amid Chaos, and Biden’s First 100 Days - How Francis Collins sees the COVID response changing with the new administration

The National Strategy From the COVID-19 Response and Pandemic Preparedness

Winners of HHS Design-a-thon to Develop Innovative Digital Health Tools for COVID-19 At-Anywhere Diagnostic Tests Announced

The Need for More and Better Testing for COVID-19