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Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like.
Marble, Hetal D; Bard, Adam Z; Mizrachi, Mark M; Lennerz, Jochen K.
  • Marble HD; Center for Integrated Diagnostics, Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.
  • Bard AZ; Center for Integrated Diagnostics, Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.
  • Mizrachi MM; Center for Autoimmune Musculoskeletal and Hematopoietic Diseases, Institute of Molecular Medicine, The Feinstein Institutes for Medical Research, Manhasset, New York; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.
  • Lennerz JK; Center for Integrated Diagnostics, Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts. Electronic address: jlennerz@partners.org.
J Mol Diagn ; 23(10): 1207-1217, 2021 10.
Article in English | MEDLINE | ID: covidwho-1428187
ABSTRACT
The coronavirus disease 2019 (COVID-19) response necessitated innovations and a series of regulatory deviations that also affected laboratory-developed tests (LDTs). To examine real-world consequences and specify regulatory paradigm shifts, legislative proposals were aligned on a common timeline with Emergency Use Authorization (EUA) of LDTs and the US Food and Drug Administration (FDA)-orchestrated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) labeling update study. The initial EUA adoption by LDT developers shows that the FDA can have oversight over LDTs. We used efficiency-corrected microcosting of our EUA PCR assay to estimate the national cost of the labeling update study to $0.3 to $1.4 million US dollars. Labeling update study performance data showed lower average detection limits in commercial in vitro diagnostic (IVD) assays versus LDTs (32,000 ± 75,000 versus 71,000 ± 147,000 nucleic acid amplification tests/mL; P = 0.04); however, comparison also shows that FDA review of IVD assays and LDTs did not prevent differences between initial and labeling update performance (IVD assay, P < 0.0001; LDT, P = 0.003). The regulatory shifts re-emphasized that both commercial tests and LDTs rely heavily on laboratory competence and procedures; however, lack of performance data on authorized tests, when clinically implemented, precludes assessment of the benefit related to regulatory review. Temporary regulatory deviations during the pandemic and regulatory science tools (ie, reference material) have generated valuable real-world evidence to inform pending legislation regarding LDT regulation.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: United States Food and Drug Administration / Polymerase Chain Reaction / COVID-19 Nucleic Acid Testing Type of study: Diagnostic study / Prognostic study Limits: Humans Country/Region as subject: North America Language: English Journal: J Mol Diagn Journal subject: Molecular Biology Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: United States Food and Drug Administration / Polymerase Chain Reaction / COVID-19 Nucleic Acid Testing Type of study: Diagnostic study / Prognostic study Limits: Humans Country/Region as subject: North America Language: English Journal: J Mol Diagn Journal subject: Molecular Biology Year: 2021 Document Type: Article