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Labcorp Gets EUA for Automated Nanopore Sequencing-Based COVID Test

NEW YORK – The US Food and Drug Administration last week granted Emergency Use Authorization to Laboratory Corporation of America for a nanopore sequencing-based assay to detect SARS-CoV-2.

The assay, called the Clear Dx SARS-CoV-2 WGS v3.0 Test, is performed using the MinIon sequencer from Oxford Nanopore Technologies and the Clear Labs Clear Dx automated sample prep and analysis pipeline.

It is intended for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages, according to the FDA's authorization letter.

Testing with the Labcorp Clear Dx SARS-CoV-2 WGS v3.0 Test is limited to CLIA labs that are qualified to perform high-complexity testing and that are designated by Labcorp.

Clear Labs obtained EUA for a MinIon-based SARS-CoV-2 test on the Clear Dx system in 2020 as well as for an assay using the higher-throughput GridIon in 2022. Lab automation is reportedly on the rise due to staffing concerns and Clear Labs has claimed that 60 percent of US public health labs have adopted the Clear Dx system for COVID surveillance.

Oxford Nanopore, meanwhile, formed a nonexclusive agreement with BioMérieux in April to explore the development of routine sequencing-based infectious disease applications.