Genedrive CEO David Budd details launch of its unique coronavirus test kits and plans for first sale, in an interview for Proactive Investors. The first, which was CE marked last week, is a high-throughput lab-based PCR test which assesses whether someone has an active infection.
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
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.
Budd also discusses WHO approval received for its HCV test as well as new distribution arrangements for its infant deafness test.