BioMedNewsBreaks – XPhyto Therapeutics Corp. (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT) Announces Completion of European CE-IVD Application for 25-Minute COVID-19 RT-PCR Test
Feb 16, 2021
XPhyto Therapeutics (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT) has made a significant announcement, along with its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”). The companies have completed all actions and procedures required for the European regulatory application for the rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR Test System. The announcement noted that ISO 13485 approval for 3a as a medical device manufacturer is expected in the next few weeks; 3a also anticipates European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for COVID-ID Lab by early March. The exclusive lab is designed to be a rapid, accurate and robust test system that offers increased convenience and portability with lower operating costs. XPhyto noted that it is in discussions with potential distribution and wholesale partners in Europe and the Middle East, with a European sales launch target of April 2021. A bioscience accelerator at the leading-edge of the life science industry, XPhyto and 3a are also working together to develop oral biosensor screening tests for detection of a range of bacterial and viral infectious diseases, including influenza A, group A strep, stomatitis, periimplantitis and periodontitis. The announcement also noted that XPhyto has additional pandemic-focused biosensors in development, specifically targeting swine flu and avian flu. XPhyto anticipates commercial launch of its first biosensor product later this year. “We are very pleased with the team’s swift development progress,” said XPhyto CEO and director Hugh Rogers. “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.”
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About XPhyto Therapeutics Corp.
XPhyto Therapeutics 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. XPhyto has research and development operations in North America and Europe, with an operational focus in Germany, and the company is currently focused on regulatory approval and commercialization of medical products for European markets. For more information about this company, please visit www.XPhyto.com
NOTE TO INVESTORS: The latest news and updates relating to XPHYF are available in the company’s newsroom at https://ibn.fm/XPHYF
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