Genedrive have made headway in rapid point of care molecular tests for Covid-19.
Genedrive shares were trading up 20.7% at 17.5p after their update on Wednesday.
On Wednesday, Genedrive provided an update which stated that the near patient molecular diagnostics company has entered distribution agreements for their rapid point of care molecular test for Covid-19.
Genedrive COV19-ID kit is a rapid molecular diagnostic testing kit. Positive results are delivered in 7 minutes and negative results are delivered in 17 minutes by the Genedrive COV19-ID kit. The results are extracted by Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation.
The test is performed by administrating a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants.
The product was CE marked on 8th December, 2021 enabling distribution in Spain, Portugal, Oman and the United Arab Emirates. Opportunities in the EU are currently under assessment. The main market for distribution of the Genedrive COV19-ID kit are including pharmacies, sports and private workplace.
Genedrive say the distribution agreements will provide the opportunity to access to the longer-term market potential in each country.
End-user product evaluation is underway in the UK in order to access certain occupational health markets.
CTDA approval is pending in the UK, therefore, commercial distribution is at a halt. The UK government is assessing the statutory requirements for COVID testing and opportunities for Genedrive depend on it.
“Progress since CE marking is as expected in terms of timeline and a focus on specific use cases. We are pleased with the distributor agreements we have contracted to date and expect to expand to additional countries in due course. While UK government policy has changed, opportunities are continuing in other markets that are taking a different approach with regards to testing,” said David Budd, CEO of Genedrive.