Diagnostics Evidence Accelerator

The Diagnostics Accelerator replicated the two Therapeutic Evidence Accelerator workstreams to address the diagnostic and serological study space. The Diagnostics Evidence Accelerator Lab Meeting convened the real-world data community to present and discuss information on recent analyses of real-world data related to diagnostic test performance, contemporaneous symptoms and presentation, surveillance trends and immunity. Participants included experts from FDA, major health data/technology organizations, academia, professional societies, health systems, insurers, and drug and device industries. Meetings explored topics such as the testing patterns and learnings from within the National Basketball Association bubble, the utility of Cycle Threshold (Ct) values, and a presentation on the National Cancer Institute’s SARS-CoV-2 Serology studies.

This Video demonstrates the data-connection goal (and challenges) for the Diagnostics Evidence Accelerator work, as discussed in our August 20th meeting.

Download the PDF here

Diagnostics Evidence Accelerator Parallel Work Group: With lessons learned from the Therapeutics Evidence Accelerator Parallel Analysis Work Group, this workstream brought analytic partners together to address key research questions about diagnostic testing in parallel. Initial activities of this work stream include (1) rapidly revising a list of core data elements; (2) identifying those elements critical to answering the primary question; and (3) establishing uniform collection parameters. This group worked collaboratively to determine how data elements are being extracted and how they are being defined to operationalize a platform that can answer current research questions.


EvAcc Header Graphic 02032022


Over 150 organizations participated in the Diagnostics Evidence Accelerator, including the following:

  • Aetion
  • Ciox Real World Data
  • CSL Behring
  • Duke-Margolis Center for Health Policy
  • Flatiron Health
  • Health Catalyst
  • HealthVerity
  • Imperial College Health Partners
  • IVD Industry Connectivity Consortium
  • Lahey Hospital & Medical Center
  • Lilly
  • Mayo Clinic
  • Medical Device Innovation Consortium
  • NorthWest EHealth Limited
  • Regenstrief Institute
  • Roche
  • UnitedHealth Group
  • University of California Health System

Meeting Summaries


From Open-Source SARS-CoV-2 PCR Test to Broader Public Health Initiative/Heidi the Hypothetical Patient
Diagnostics: Pandemic's Next Phase - COVID and Beyond/Real World Data Survey Checklist
Updates from CDRH/Minimum Data Elements/Using Various Timestamps in the Context of HIE and the Indiana COVID-19 Response
COVID-19 Testing Strategy Update/An Interoperability Discussion
Viral Diagnostics and Sequencing for SARS-CoV-2/Discussion of Minimum Data Sets
NFL-NFLPA COVID-19 Monitoring Program
CDRH Opening Remarks/Where Are We in The Data Flow/Quest Diagnostics Data Resources/Q&A with Chris Stanley and Bill St. Pierre, Labcorp and Dr. William Meyer, Quest Diagnostics
Data Interoperability/Unique Device Identifiers/Ten Things You Need to Know About Working with COVID-19 Diagnostic/Serology Laboratory Data
Challenges in Surveillance Testing/Patient Safety and SHIELD
Diagnostics: The Key to the Beginning, Middle, & End of the Pandemic
Overview of NOLA-PS COVID-19 Testing Strategy/Neutralizing Serology in the Setting of Vaccination
Learnings from COVID Testing/Managing an Emerging Pandemic
Diagnostics Parallel Analysis Project One Readout/COVID Testing Priorities/CDC-NIH At-Home Testing Initiative
How Integrated Data and HIE Can Support COVID-19 Response/Assessing Vaccine Effectiveness: Israel's Case Study
Heidi: A Story of Data Interoperability/Front Porch Chat with HHS National Coordinator for Health Information Technology/Decoding the T-Cell Response to SARS-CoV-2

Lab Meeting Summary 4/15/2021

HHS Design-a-thon At-Home Diagnostics/COVID-19 Testing and Vaccine Update
Trajectory of SARS-CoV-2 Pandemic/Interoperability: Impetus for Change/Introducing "Heidi for Vaccines" and the Vaccines Evidence Accelerator
Update on the Diagnostics Evidence Accelerator Lab "Retro"/Guidance of Evaluating Impact of Viral Mutations on COVID-19 Tests and Lessons Learned thus Far/SARS-CoV-2 Genome Surveillance/FDA's Data Modernization Action Plan
Chicago COVID-19 Health Information Exchange/A Brief History of Interoperability
Workplace Employer Alliance for COVID-19 Testing/Parabola Project/Dascena Ct Value Preliminary Result


NFL COVID-19 Monitoring Program/NCI SARS-CoV-2 Serology Studies
COVID-19 Testing Strategy at Colby College/Testing in K-12 Schools
COVID-19 At-Anywhere Diagnostics Design-a-thon/COVID-19 Testing at Walgreens/Abbott Rapid Diagnostics
NBA's COVID Testing Strategy/Decoding the T-Cell Response in SARS-CoV-2/UHG COVID-19 Testing Strategy Simulator
Project One Feasibility Assessment/Presentation of Aim 1 Characterization from Analytic Partners 
The Importance of Using Ct Value/Testing Strategies for Containment/Connecting the Dots 
Leveraging the Diagnostics Evidence Accelerator/LOINC Codes and SARS-CoV-2/Role of Lab-Hubs/Project One Update 
Clinical Utilization of SARS-CoV-2 Serology Tests/RADx Update/Tracking COVID-19, Influenza and RSV/Project One Update 
"Heidi's Journey"/Building THE Ideal Data Set/COVID-19 Antibody Testing/Addressing Potential Bias in RWE 
Saliva Direct/Update on FDA-authorization for the Use of Saliva/Project One Data Visualization and Accelerators 
Clinical Dx COVID RWE Update/HHS Reporting and Device Identifier Challenges/Chicago Department of Pub Health Data Hub 
HHS Guidance on Lab Data Reporting/Real World Analysis of Serology Diagnostics/Preliminary Descriptive Analysis:COVID-19 Lab Diagnostics
Rapid Acceleration of Diagnostics Advanced Technology Platforms (RADx-ATP)/Data Reporting/Connecting to Project One 
Updates on Connecting the Pipes/A Window into the CA COVID-19 Testing Experience/CRISP and Regenstrief Info Exchange 
What are We Learning About the Data/UnitedHealth Group Testing Activity/HHS PROTECT Requirements 
Danaher PCR and Serology Testing/Verily's Baseline and COVID-19 Support/Different Data Sources and Connections 
Connecting the Data Pipes/RWE for Medical Devices/Office of Surveillance and Epidemiology at CDER/Univ Cali Health Systems 
Connecting the Pipes/Solutions to Common Challenges with RWDs & IVDs/Yale & Mayo Data Sharing Platform/Data Sharing 
RWE Generation: Advancing Regulatory Science and Patient Access for IVDs/CDC Lab Reporting Requirement 
ACORN Study/Real-time RWD COVID Insights and Evidence/Case Finding via Lab Testing/Univ Cali Health Sys/Feedback 
EvAcc Model and Dx Approach/NIH's Efforts in Diagnostic Testing/Research Questions/Standards