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.
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.
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
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
From Open-Source SARS-CoV-2 PCR Test to Broader Public Health Initiative/Heidi the Hypothetical Patient
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
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
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
