Xphyto expects European nod for COVID-19 test in Q1
2020-12-17 07:38 ET – News Release
Mr. Hugh Rogers reports
XPHYTO COMPLETES SUCCESSFUL SARS-COV-2 RT-PCR DIAGNOSTIC TEST KIT VALIDATION
XPhyto Therapeutics Corp. and its exclusive German diagnostics development partner, 3a-diagnostics GmbH, have successfully validated 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.
About XPhyto Therapeutics Corp.
XPhyto Therapeutics Corp. is a bioscience accelerator focused on next-generation drug delivery, diagnostic, and new active pharmaceutical ingredient investment opportunities, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization of emerging active pharmaceutical ingredients for neurological applications, including psychedelic compounds and cannabinoids. The Company has research and development operations in North America and Europe and is currently focused on regulatory approval and commercialization of medical products for European markets.