Genedrive gets approval for Covid-19 kit in South Africa
By Josh White
Date: Wednesday 30 Sep 2020
(Sharecast News) - Molecular diagnostics company Genedrive announced on Wednesday that its 'Genedrive 96' SARS-CoV-2 kit has received approval from the South African Health Products Regulatory Authority, having been submitted for evaluation in June.
The AIM-traded firm said that under the approval, the kit could now be distributed and sold within the Republic of South Africa.
It said its products are supplied in the country, and more broadly within Africa, via the Sysmex EMEA organisation.
Since the original evaluation, Genedrive said it had expanded the number of PCR platforms and RNA isolation kit providers which were validated for its kit.
That, it said, was important for markets such as South Africa, where high testing volumes were supported by the prevalence of automated and robotic RNA extraction instruments, and the variety of testing platforms was diverse owing to a split between public and private testing facilities.
"This is an important milestone in the commercialisation of our Covid-19 Kit in the region," said chief executive officer David Budd.
"South Africa is a key territory for our distributors and this approval will now provide an acceleration of commercial sales activity in the area."
At 1630 BST, shares in Genedrive were up 5.74% at 110.5p.
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