XPhyto Therapeutics Corp (CSE:XPHY) (OTCQB:XPHYF) (FRA:4XT) announced Tuesday that all steps required for the European regulatory application for the company’s rapid point-of-care coronavirus (COVID-19) RT-PCR test system have been completed.
The company and its German diagnostics development partner, 3a-diagnostics GmbH, expect to receive ISO 13485 approval as a medical device manufacturer by late February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) by early March.
The test system, Covid-ID Lab, was designed to be a rapid, accurate and robust test system with reduced operating costs and increased convenience and portability, the company said. The sales launch in Europe is targeted for April 2021.
Initial manufacturing is planned for Germany with additional capacity in other jurisdictions to follow, the company said. XPhyto is in discussions with potential distribution and wholesale partners in Europe and the Middle East.
“We are very pleased with the team’s swift development progress,” CEO Hugh Rogers said in a statement. “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, peri implantitis and periodontitis. Additional pandemic-focused biosensors are in development, specifically for H1N1 (swine flu) and H5N1 (avian flu). The company said it is planning the commercial launch of its first biosensor product in the second half of 2021.
Contact Andrew Kessel at [email protected]
Follow him on Twitter @andrew_kessel
Story by ProactiveInvestors
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