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 placed an initial order for rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system. The test systems, known as COVID-ID Labs, were ordered from XPhyto’s exclusive diagnostic development partner, 3a-diagnostics GmbH (“3a”). The first order consists of 9,600 individual tests; the tests are packaged in 200 kits of 48 tests each. The tests, which should arrive by mid-March 2021, will be used as samples for review and evaluation and will be primarily given to prospective distribution partners and licensees along with government regulators. Designed to be a rapid, accurate, and robust COVID-19 test system, the COVID-ID Labs offer reduced operating costs along with greater convenience and portability. In the announcement, XPhyto noted that it anticipates 3a to receive ISO 13485 medical device manufacturer approval later this month; the announcement also noted that European regulatory approval as a commercial in vitro diagnostic device (“CE-IVD”) for Covid-ID Lab was expected by March. The company intends to begin manufacturing in the German state of Baden-Württemberg, with a commercial sales launch in April 2021. Depending on response, manufacturing in other locations is possible. XPhyto is exploring potential distribution and wholesale partners in Europe and the Middle East. In addition, XPhyto and 3a are working together to offer a portfolio of oral biosensor screening tests. These tests would identify bacterial and viral infectious diseases, including influenza A, group A strep, stomatitis, periimplantitis and even periodontitis. “We are pleased to report that all steps towards the launch of Covid-ID Lab remain on track within an ambitious timeline,” said XPhyto CEO and director Hugh Rogers in the press release. “Our experienced market launch team is working quickly to bring the product to market, as well as to establish licensing and distribution partnerships. We are confident that Covid-ID Lab, as a 25-minute PCR test with minimal technical and personnel requirements, will be a stand-out product in the COVID-19 test market.”
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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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