XPhyto European CE-IVD Application For 25-Minute COVID-19 RT-PCR Test
Vancouver, Canada (February 16, 2021) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce that all actions and procedures required for its European regulatory application for the rapid point-of-care SARS-CoV-2 (COVID19) RT-PCR Test System (“Covid-ID Lab”) have been completed. 3a expects ISO 13485 approval as a medical device manufacturer by late February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March.
Covid-ID Lab was designed to be a rapid, accurate and robust test system with reduced operating costs and increased convenience and portability. Initial manufacturing is planned for Germany with additional capacity in other jurisdictions to follow. The sales launch in Europe is targeted for April 2021. XPhyto is currently in discussions with potential distribution and wholesale partners in Europe and the Middle East. The Company will provide further information and updates in due course.
“We are very pleased with the team’s swift development progress,” said Hugh Rogers, CEO & Director of XPhyto. “Our goal was to create the fastest and most portable COVID-19 PCR test on the market. We are confident in our prospects for an expedited approval and look forward to commercial launch in short order.”
XPhyto and 3a are also developing a portfolio of oral biosensor screening tests for detection of bacterial and viral infectious diseases, including influenza A, group A strep, stomatitis, periimplantitis, and periodontitis. Additional pandemic-focused biosensors are in development, specifically for H1N1 (swine flu), and H5N1 (avian flu). The Company is planning commercial launch of its first biosensor product in the second half of 2021.
The Company is not making any express or implied claims that its product has the ability to
eliminate, cure or contain the COVID-19 pandemic.