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Xphyto $XPHY.ca $XPHYF European CE-IVD Application for 25-Minute COVID-19 RT-PCR Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:11 AM on Tuesday, February 16th, 2021
  • Expects approval as a medical device manufacturer by late February
  • European regulatory approval as a commercial in vitro diagnostic device 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.

XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce all actions and procedures required for XPhyto Therapeutics Corp.’s European regulatory application for the rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system have been completed. 3a-diagnostics GmbH, Xphyto’s exclusive German diagnostics development partner, 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.

“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”

Read More: https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/755390-xphyto-european-ce-ivd-application-for-25-minute-covid-19-rt-pcr-test/messages/2303789#message

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