RE: FDA has no objection8 Feb 2021 16:16
Genedrive PLC (LON:GDR) shares jumped higher on Wednesday as it told investors that 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”.
Genedrive pointed out the FDA does not object to the distribution of SARS-CoV-2 test kits without emergency use sign-off under certain defined conditions as coronavirus cases in the US continue to soar.