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Oxford Nanopore SARS-CoV-2 Sequencing Test Gets CE Mark

NEW YORK – Oxford Nanopore Technologies said on Friday that its LamPore SARS-CoV-2 sequencing test has obtained the CE mark for use with the GridIon platform.

The assay, which combines loop-mediated isotheral amplification (LAMP) with nanopore sequencing and can run on the GridIon and MinIon Mk1C platforms, targets the ORF1a, E, and N genes of the virus. Last month, researchers in the UK published a preprint of a validation study involving around 500 clinical samples, showing that the test is highly reproducible and has a sensitivity of 99.1 percent and a specificity of 99.6 percent.

Oxford Nanopore is rolling the LamPore test out globally, initially in the UK, Germany, Switzerland, and the United Arab Emirates, according to a company statement.

It is also pursuing regulatory approvals in other countries, including Emergency Use Authorization in the US and, in collaboration with G42, authorization in the United Arab Emirates.