Navigating Next-Generation Sequencing Laboratory Developed Tests: A Critical Look at Proficiency Testing, US Food and Drug Administration Regulations, and Clinical Laboratory Performance

Arch Pathol Lab Med. 2024 Feb 1;148(2):136-138. doi: 10.5858/arpa.2023-0477-ED.

Authors

Shuko Harada¹, Alexander C Mackinnon¹

Affiliation

¹ From the Department of Pathology, The University of Alabama, Birmingham.

PMID: 37934951
DOI: 10.5858/arpa.2023-0477-ED

No abstract available

MeSH terms

Clinical Laboratory Services*
High-Throughput Nucleotide Sequencing
Humans
Laboratories
Laboratories, Clinical*
Laboratory Proficiency Testing
United States
United States Food and Drug Administration