Genedrive (LON: GDR) told investors Monday that it has submitted its new Covid-19 molecular test for CE-IVD certification.
The molecular diagnostics company said following self-certification, the Genedrive COV19-ID Kit has been passed to the company's authorised representative for formal registration, a process expected to take ten working days to complete. Once finished, the product can be made available commercially in the European Union.
Additionally, the product is being provided for review and evaluation to a range of potential commercial partners who have expressed interest in the product.
At the time of writing, Genedrive shares are trading 9% above Friday's close.
Genedrive said its initial focus will be on the EU, utilising the regulatory clearance of CE marking, followed by the UK.
The company's CEO, David Budd, explained: “We are now able to progress the commercial evaluations of the product to selected partners and given its performance in our studies, we believe there remain substantial market opportunities that can be targeted.”
He added that “recent news of the Omicron variant demonstrates, COVID-19 remains a significant issue in global health.” However, investors in Europe seem to already be buying the recent dip with one of the first South African doctors to treat the variant saying symptoms were mild.
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