XPhyto Therapeutics Corp (CSE:XPHY) (OTCQB:XPHYF) FRA:4XT) and its German diagnostics development partner 3a-diagnostics GmbH have announced successful EN ISO 13485 certification for the rapid point-of-care, SARS-CoV-2 RT-PCR Test System (Covid-ID Lab).
XPhyto said this standardization and quality assurance certification provides authorization for distribution of Covid-ID Lab upon receipt of the 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.
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"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 XPhyto CEO Hugh Roger in a statement Wednesday. "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."
XPhyto said the 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.
The company in February placed its first production order from 3a-diagnostics for 9,600 individual tests. Delivery of this first order 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 and XPhyto is currently in discussions with potential distribution and wholesale partners in Europe and the Middle East.
XPhyto and 3a-diagnostics 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).
XPhyto said it is planning the commercial launch of its first biosensor product in the second half of 2021.
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