RE: AVCT investor27 May 2020 13:55
Recent info:
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that the Genedrive® 96 SARS-CoV-2 Kit is now CE-IVDmarkedand isavailable for commercial sale across the European Union, including the UK, whilst also acceleratingmarket access to countries that accepttheCE-IVDmark.The Genedrive®96 SARS-CoV-2 Kitis a novel Polymerase Chain Reaction (PCR) assay designed to detect activeinfection in COVID-19 patients. genedrive’s PCR bead formateliminatesthe need for the time consumingand error-pronereagent preparationrequiredin all other open-platform test kits.The proprietary format streamlines laboratory workflow, allowing more teststo be performed in a day. Patientsamples are simply mixed with the PCR beads,and are then analysed on a variety of existing third-partyreal time PCR platforms.DuringCE-IVD evaluationson 180 randomised specimens, the Genedrive® 96 SARS-CoV-2 Kit achieved 100% sensitivity and 98.2% specificity, placing it in atop tierperformance table for COVID-19 PCR tests.The test has been co-developed with Cytiva (formerly GE Healthcare Life Sciences). The scalable manufacturing process uses Cytiva’sLyo-Stable™ validated manufacturing method, capable of producing 10,000 PCR beads per hour.The Genedrive®96 SARS-CoV-2 kitis stableat ambient temperatureswhich eliminates the need for cold storage,makingthe test very practical forglobalexport markets.Following CE-IVDmarking, the Company can commence commercial sales in the UK and across the EU immediately. The Company will now begin distribution to potential customers for initial clinical evaluations,and aims to recordfirst commercial sales in June.
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