22nd Dec 2021 11:34
(Alliance News) - Genedrive PLC shares jumped on Wednesday after it said it has filed for approval of its Covid-19 testing kit for sale in the UK.
Shares in Genedrive were up 24% at 44.99 pence on Wednesday morning in London.
The Manchester-based diagnostics company said that its Covid-19 testing kit had now been filed for approval to sell in the UK under that new Coronavirus Test Device Approvals regulations that came into effect last month.
The clinical validation required for CTDA approval of the kit was referenced against Thermo Fisher Scientific Inc's TaqPath Covid-19 PCR test. Thermo Fisher is Massachusetts-based scientific instrument company.
In the 264 samples, specificity was 98% and sensitivity was 98% in samples with viral load more than 500 copies per millilitre. This cohort included samples of the Omicron variant, all of which were successfully detected, Genedrive added.
The sensitivity and specificity of the Genedrive assay met the current requirements of the UK Medicines & Healthcare Regulatory Agency's target product profile for Covid point-of-care molecular diagnostic tests.
Genedrive said its kit delivers positive results in as quickly as seven and a half minutes and negative results in around 17 minutes.
Chief Executive David Budd said the next milestone for the kit is approval by the UK Department of Health & Social Care but added that there was no assured timeline on how long the review will take.
By Heather Rydings; [email protected]
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