Dec 17, 2020 in Diagnostics, Press Releases
XPhyto Completes Successful SARS-COV-2 RT-PCR Diagnostic Test Kit Validation
Vancouver, Canada (December 17, 2020) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”), a next-generation bioscience accelerator, and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce the successful validation of their point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system. European regulatory approval and commercial product launch in European markets are planned for Q1 2021.
The newly developed SARS-CoV-2 RT-PCR test system has demonstrated diagnostic level accuracy (sensitivity and specificity) in its ability to detect SARS-CoV-2 RNA within 25 minutes. Robustness, repeatability, and laboratory precision have also been confirmed. The test is designed to be conducted with only minimal laboratory processes and equipment.
“Successful test validation is a critical milestone on the pathway to accelerated commercialization,” said Hugh Rogers, CEO of XPhyto. “With no need for large, specialized laboratories, our system is particularly well suited for point-of-care testing. We believe this will provide increased speed, convenience, and flexibility for the immediate identification of infected people in a wider variety of settings through the use of satellite and mobile labs.”
The Company will provide further details on the validation results and methodology, regulatory approval process, and commercialization strategy in due course.
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.