Molecular diagnostics company Genedrive updated the market on progress on the ‘Genedrive COV19-ID’ kit – its rapid point of care molecular test for Covid-19 – on Wednesday.
The AIM-traded firm described the kit as a “rapid molecular diagnostic test”, that delivers positive results from 7.5 minutes, and negative results at 17 minutes.
It said it uses reverse-transcription loop mediated isothermal amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without viral extraction.
Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, which Genedrive said added “robustness” against emerging Covid-19 variants.
The product was CE-marked on 8 December, and was subsequently sent for evaluation purposes to interested parties.
Genedrive said it had now entered into distribution agreements covering Spain, Portugal, Oman and the United Arab Emirates, with other opportunities continuing to be assessed in other European Union countries.
The customer base that distributors were targeting was consistent with those the company previously identified, including pharmacies, sports and private workplaces.
Market requirements differed from country to country depending on government policies and legislation, with Genedrive saying the initial distributor arrangements were designed to both access and assess the longer-term market potential in each country.
The firm also had end-user product evaluation ongoing in the UK to access specific occupational health markets.
It said the product could not yet be commercially sold in the UK, as approval was still pending, although with UK government statutory requirements for Covid-19 testing soon changing, it said future opportunities there would be discretionary testing, as opposed to the current government mandates.
The company said it would continue with its commercial steps to build its sales pipeline and grow revenues.
“Progress since CE-marking is as expected in terms of timeline and a focus on specific use cases,” said chief executive officer David Budd.