Feb 24, 2021 in Diagnostics, Press Releases
XPhyto Places First Order For 25-Minute COVID-19 RT-PCR Tests
Vancouver, Canada (February 24, 2021) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”), is pleased to announce that it has placed the first order for its rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”) from its exclusive diagnostic development partner, 3a-diagnostics GmbH (“3a”).
The first order of Covid-ID Lab is for 9,600 individual tests which are packaged in 200 kits of 48 tests each. Delivery of the first order is expected by mid-March 2021 and will be primarily used to supply prospective distribution partners and licensees and their respective government regulators with tests samples for review and evaluation. The tests will be manufactured in the German state of Baden-Württemberg.
“We are pleased to report that all steps towards the launch of Covid-ID Lab remain on track within an ambitious timeline,” said Hugh Rogers, CEO and Director of XPhyto. “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.”
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. XPhyto expects 3a to receive ISO 13485 medical device manufacturer approval by the end of February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March. Initial commercial manufacturing is planned for Germany, with additional capacity in other jurisdictions 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.