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Genedrive 96 SARS-CoV-2 Kit receives CE-IVD Mark
Genedrive 96 SARS-CoV-2 Kit receives CE-IVD Mark.
About this update from Genedrive Plc
[{"type":"text","content":"\n \n \n RNS Number : 6850N\n Genedrive PLC\n 22 May 2020\n \n \n \n \n genedrive plc\n \n \n (\"genedrive\" or the \"Company\")\n \n \n Genedrive® 96 SARS-CoV-2 Kit receives CE-IVD Mark\n \n New easy-to-use test PCR format to support increased high-throughput Coronavirus testing\n \n \n \n \n \n genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that the Genedrive® 96 SARS-CoV-2 Kit is now CE-IVD marked and is available for commercial sale across the European Union, including the UK, whilst also accelerating market access to countries that accept the CE-IVD mark. \n \n \n \n \n \n The Genedrive® 96 SARS-CoV-2 Kit is a novel Polymerase Chain Reaction (PCR) assay designed to detect active infection in COVID-19 patients. genedrive's PCR bead format eliminates the need for the time consuming and error-prone reagent preparation required in all other open-platform test kits. The proprietary format streamlines laboratory workflow, allowing more tests to be performed in a day. Patient samples are simply mixed with the PCR beads, and are then analysed on a variety of existing third-party real time PCR platforms. During CE-IVD evaluations on 180 randomised specimens, the Genedrive® 96 SARS-CoV-2 Kit achieved 100% sensitivity and 98.2% specificity, placing it in a top tier performance table for COVID-19 PCR tests.\n \n \n \n \n \n The test has been co-developed with Cytiva (formerly GE Healthcare Life Sciences). The scalable manufacturing process uses Cytiva's Lyo-Stable™ validated manufacturing method, capable of producing 10,000 PCR beads per hour. The Genedrive® 96 SARS-CoV-2 kit is stable at ambient temperatures which eliminates the need for cold storage, making the test very practical for global export markets.\n \n \n \n \n \n Following CE-IVD marking, 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 record first commercial sales in June. \n \n \n \n \n \n The Company continues to develop a point-of care version of the SARS-CoV-2 test for use with its Genedrive® platform, which will enable decentralised testing.\n \n \n \n \n \n \n David Budd, Chief Executive Officer of genedrive plc, said: \n \n \n \"The develop...