Genedrive’s COV19-ID Kit Granted UKCA Approval

The UK Medicines and Healthcare products Regulatory Agency has approved Genedrive’s COV19-ID Kit, a rapid point-of-care molecular test that can deliver positive results in 7.5 minutes and negative results in 17 minutes.

The assay, which uses a proprietary buffer formulation, works directly on nasal swab samples and targets two genes of the SARS-CoV-2 virus, enabling the test to detect emerging variants, the company said.

Manchester, UK-based Genedrive previously received a CE mark for the test and has entered into marketing agreements with commercial partners to supply it in European countries.