Last RNS27 Jan 2022 20:28
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that, further to the announcement on 29 November 2021 confirming submission for CE-IVD certification for the Genedrive® COV19-ID Kit, expanded product validation requirements have now been completed and the Company has filed for approval to sell the product in the United Kingdom under the new Coronavirus Test Device Approvals (CTDA) regulations1. CTDA regulations came into effect on 1 Nov 2021 and place specific registration, review and performance requirements on suppliers of COVID-19 diagnostic products into the United Kingdom.
The expanded clinical validation sample cohort required for CTDA approval was referenced against the Thermo Fisher TaqPath COVID-19 RT-PCR test. In the 264 samples, specificity was 98%, and sensitivity was 98% in samples with viral load >500 copies per ml. This cohort included samples of confirmed Omicron variant, all of which were successfully detected. The sensitivity and specificity of the Genedrive® COV19-ID assay on the entire cohort met the current requirements of the UK's MHRA Target Product Profile for SARS-CoV-2 Point-of-Care molecular diagnostic tests.
How’s the approval going for a country that thinks covid is over. ? Sales update ?