Challenges in Structuring SARS-CoV-2 Emergency Use Authorization Diagnostics Data: Leveraging Findable, Accessible, Interoperable, and Reusable Principles for the Next Era of Diagnostic Data Transparency
Converging efforts from disparate groups to extract and synthesize FDA test data reveal an unaddressed need for better organization and communication. Existing FDA data reporting systems must be improved and adapted for the demands of the connected data science era.
Authors
- W. D. Stone
- Stephanie Ishack (ORCID: https://orcid.org/0000-0002-2627-7791)
- S. Don
- Ashley J. Phillips (ORCID: https://orcid.org/0000-0002-8547-0719)
- Faten A. Okda (ORCID: https://orcid.org/0000-0001-6245-5391)
- Singh Rajesh
- Mike Reed (ORCID: https://orcid.org/0000-0002-6309-2710)
- Hung S. Luu (ORCID: https://orcid.org/0000-0003-2001-4031)
- Karthik Dinakar
- Richard S. Creager (ORCID: https://orcid.org/0000-0001-5488-4444)
- Anthony Morrison (ORCID: https://orcid.org/0000-0003-4562-096X)
- Riki Merrick
- Cesia Gallegos
- Samantha Bates Weinstock
- Yu Lin (ORCID: https://orcid.org/0000-0003-2620-0345)
- Aaron L Glieberman
- Veronique T Baron
- Anna Borchers
Institutions
- American Medical Informatics Association (US)
- Association of Public Health Laboratories (US)
- St. Jude Children's Research Hospital (US)
- Mayo Clinic (US)
- City University of New York (US)
- Amherst College (US)
- Lasell College (US)
- University of Massachusetts Amherst (US)
- Philips (United Kingdom) (GB)
- National Human Genome Research Institute (US)
- Southwestern Medical Center (US)
- Mount Sinai Hospital (US)
- Morrison Tech (US)
- Neuronetics (United States) (US)
- Mayo Clinic in Florida (US)
- Layton BioScience (United States) (US)
- Heat Transfer Research & Development (United States) (US)
- New England Complex Systems Institute (US)
- The University of Texas Southwestern Medical Center (US)
Publication Details
- Journal
- Archives of Pathology & Laboratory Medicine
- Published
- 2025-12-12
- DOI
- https://doi.org/10.5858/arpa.2025-0144-oa
- Primary Topic
- SARS-CoV-2 detection and testing
- Type
- article
- Field-Weighted Citation Impact
- 0.00