Diagnostics Evidence Accelerator

The Diagnostics Accelerator replicates the two Therapeutic Evidence Accelerator workstreams to address the diagnostic and serological study space. The Diagnostics Evidence Accelerator Lab Meeting convenes 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 include experts from FDA, major health data/technology organizations, academia, professional societies, health systems, insurers, and drug and device industries. Recent meetings explored topics such as the testing patterns and learnings from within the National Basketball Association bubble, the relevance of Cycle Threshold (Ct), and a presentation on the National Cancer Institute’s SARS-CoV-2 Serology studies. The Diagnostics Evidence Accelerator Lab Meetings occur on the first and third Thursdays of every month from 12-1 pm ET.

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

Dx Evidence Accelerator Data Story

Watch the August 20, 2020 presentation here
Download the PDF here

Diagnostics Evidence Accelerator Parallel Work Group: With lessons learned from the Therapeutics Evidence Accelerator Parallel Analysis Work Group, this workstream brings 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 works 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.

The primary research aim is to address test characteristics that reside in a data ecosystem and use that information to address the connection between positive RNA and serology tests. There are 4 research components that the Work Group will be addressing: (1) Describe RNA tested by demographic, behavioral and environmental characteristics, baseline clinical presentation, key comorbidities, and bacterial/viral co-infections; (2) Describe serological testing by demographic, behavioral and environmental characteristics, baseline clinical presentation, key comorbidities, and bacterial/viral co-infections; (3) Characterize the timing of serology testing relative to symptom onset or RNA date by demographic, behavioral and environmental characteristics, baseline clinical presentation, key comorbidities, bacterial/viral co-infections, and test characteristics (e.g. manufacturer); and (4)Describe demographic, behavioral and environmental characteristics, baseline clinical presentation, key comorbidities, bacterial/viral co-infections, and test characteristics (e.g. manufacturer) associated with positive serology (+Ab) vs. negative serology (-AB).

Repeating analyses in parallel through collaborators using different analytical techniques and data sources helps strengthen findings and learnings. Additionally, this effort will help validate the role of real-world data as a tool for rapidly learning about patient, environment, and test characteristics in a data ecosystem (Electronic Health Record, Laboratory Information System, and Instrument), and outcomes associated with positive RNA test and serology tests for COVID-19. Diagnostics Parallel Analysis Work Group meetings occur every Friday from 3-4 pm ET.

 

Dx Graphic 10152020

 

Over 150 organizations have 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
  • IQVIA
  • 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

2021

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

2020

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