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Molecular diagnostic company Genedrive announced Wednesday that its ‘Genedrive 96’ SARS-CoV-2 kit has received approval from the South African Medical Device Regulatory Authority, having been submitted for evaluation in June.
The AIM-listed firm said that with the approval, the kit could now be distributed and sold in the Republic of South Africa.
It said its products are supplied domestically, and more widely within Africa, through the Sysmex EMEA organization.
Since the original evaluation, Genedrive said it had expanded the number of PCR platforms and RNA isolation kit vendors that were validated for its kit.
That, he said, was important for markets such as South Africa, where high test volumes were supported by the prevalence of automated and robotic RNA extraction instruments, and the variety of test platforms was diverse due to the division between public test facilities. and private.
“This is an important milestone in the commercialization of our Covid-19 kit in the region,” said Executive Director 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 16:30 BST, Genedrive shares were up 5.74% to 110.5 pence.
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