XPhyto Therapeutics (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT), a bioscience accelerator focused on next-generation drug delivery, diagnostic and new active pharmaceutical ingredient investment opportunities, has announced that 3a-diagnostics GmbH (“3a”) has received EN ISO 13485 certification for its rapid point-of-care, SARS-CoV-2 RT-PCR Test System (“Covid-ID Lab”). 3a-diagnostics is XPhyto’s exclusive German diagnostics development partner. In addition the company expects CE-IVD approval for the product this month. These two approvals will allow 3a-diagnostics GmbH to distribute the Covid-ID Lab. The EN ISO approval is the internationally recognized European standard for quality control and management systems in the category of design and manufacture of medical devices, and is accepted through Europe, denoting that the medical device has met and passed relevant European directives and regulations. XPhyto has placed its first order for the Covid-ID Lab, which is designed to be a rapid, accurate and robust COVID-19 test system that offers reduced operating costs and increased convenience and portability. XPhyto has also partnered with 3a to develop a portfolio of oral biosensor screening tests designed to detect bacterial and viral infectious diseases, such as influenza A, group A strep, stomatitis, periimplantitis and periodontitis, as well as additional pandemic-focused biosensors. The two companies anticipate the commercial launch of its first biosensor product sometime in late 2021. “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 and director Hugh Rogers in the press release. “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.”
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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
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