Mar 10, 2021 in Diagnostics, Press Releases
XPhyto Partner Receives ISO Certification for 25-Minute COVID-19 RT-PCR Test
Vancouver, Canada (March 10, 2021) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce successful EN ISO 13485 certification for the rapid point-of-care, SARS-CoV-2 RT-PCR Test System (“Covid-ID Lab”). This standardization and quality assurance certification provides authorization for distribution of Covid-ID Lab upon receipt of CE mark (CE-IVD) approval. The Company expects CE-IVD approval as an in vitro diagnostic product in March 2021.
EN ISO 13485 is the internationally recognized European standard for quality control and management systems in the design and manufacture of medical devices. It is accepted as the basis for CE certification of medical devices under relevant European directives and regulations.
“We are pleased to remain on schedule with the launch of Covid-ID Lab and will continue to move forward as efficiently as ever,” said Hugh Rogers, CEO and director of XPhyto. “At the same time, our experienced launch team is working hard to bring Covid-ID Lab to market and to establish German and international licensing and distribution partnerships.”
Covid-ID Lab was designed to be a rapid, accurate and robust COVID-19 test system with reduced operating costs and increased convenience and portability. As previously announced on February 24, 2021, the company placed its first production order from 3a for 9,600 individual tests. Delivery of this first order is expected by mid-March 2021 and is primarily intended to provide potential German and international distributors and licensees and their respective government regulators with test samples for review and evaluation. Initial commercial manufacturing is planned for Germany, with additional capacity in other jurisdictions expected to follow. The sales launch in Europe is targeted for April 2021. XPhyto is currently in discussions with potential distribution and wholesale partners in Europe and the Middle East.
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, periimplantitis, and periodontitis. Additional pandemic-focused biosensors are in development, specifically for H1N1 (swine flu), and H5N1 (avian flu). The Company is planning the commercial launch of its first biosensor product in the second half of 2021.
The Company will provide further information and updates 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. Further, its COVID-19 related test products are not yet approved and are still subject to risks associated with the regulatory approval process.