The Genedrive 96 SARS-CoV-2 kit can now be distributed and sold within South Africa, where the companies products are already supplied as part of a wider African distribution agreement with the Sysmex organisation
Since the original evaluation, Genedrive has expanded the number of polymerase chain reaction (PCR) test platforms and RNA isolation kit providers which are validated for the kit.
“This is important for markets such as South Africa where high testing volumes are supported by the prevalence of automated/robotic RNA extraction instruments, and the variety of testing platforms is diverse owing to a split between public and private testing facilities,” the company said.
Chief executive David Budd added: “This is an important milestone in the commercialisation of our COVID-19 kit in the region. South Africa is a key territory for our distributors and this approval will now provide an acceleration of commercial sales activity in the area.”