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Genedrive PLC (LON:GDR) has confirmed that its 96 SARS CoV-2 Kit continues to detect all known variants of COVID-19, including the newest string in the south-east of England.
The kit is designed to target both the E and N genes of SARS-CoV-2, said Genedrive.
The new variant involves a mutation in the highly mutagenic S gene, which encodes spike proteins, and is not one the company relies on for detection of the virus.
David Budd, chief executive, added: “We have carried out detailed in silico analysis of 155,276 sequences on the GISAID database.
“The results show that the test is able to detect all published COVID-19 strains with the same high level of accuracy and demonstrates 100% homology.
Last week, Genedrive said it would notify the US Food & Drug Administration (FDA) that it intends to import and distribute its 96 SARS-CoV-2 kit in the US prior to emergency use authorisation (EUA).
The company said it had taken the decision in order to support its collaboration agreement with Beckman Coulter that will see the pair bring to the market a fully automated coronavirus (COVID-19) testing solution. It also wants to “exploit commercial opportunities”.
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