XPhyto Therapeutics Corp. (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT) Files First Order for Rapid COVID Test Kits Amid European Regulatory Approval

  • Bioscience technology accelerator XPhyto Therapeutics Corp. recently announced it had placed its first order for its Covid-ID Lab rapid, portable virus test from its German development partner
  • XPhyto received approval for the test kit last month from European regulators with oversight of in vitro diagnostic device (CE-IVD) use certification and the internationally agreed-on ISO 13485 medical product quality standards
  • The Covid-ID Lab is designed to help beleaguered industries and government regulators quickly screen for the COVID-19 virus at point-of-care sites, and the company expects to begin sales and distribution in April
  • XPhyto has just completed a rebranding effort that includes the launch of a new website
  • The company expects to begin launching other bacteria and virus diagnostic products later this year

With confidence in the world’s mounting recovery from the COVID-19 pandemic growing this year, bioscience industry holding company XPhyto Therapeutics (CSE: XPHY) (OTCQB: XPHYF) (FSE: 4XT) is stepping up its efforts to produce and ultimately commercialize next-generation diagnostic products and new active pharmaceutical ingredients, particularly in regard to the pandemic response.

XPhyto has placed its first order for the company’s Covid-ID Lab product from its exclusive diagnostic development partner, Germany’s 3a-diagnostics GmbH, as announced in a Feb. 24 news release (https://ibn.fm/uBX94). The Covid-ID Lab is a rapid, point-of-care RT-PCR test system for COVID that the company expects to be useful for industry partners and licensees, as well as their respective government regulators, in safeguarding against the spread of the highly infectious and potentially fatal virus.

The first product order from 3a was for 9,600 tests, which are packaged in 200 kits of 48 tests each, according to the company. Delivery is expected this month and XPhyto anticipates they will then undergo evaluation by the company’s partners and the appropriate government agencies for expected commencement of sales in Q2 2021.

“We are pleased to report that all steps towards the launch of Covid-ID Lab remain on track within an ambitious timeline,” XPhyto CEO and Director Hugh Rogers stated in the news 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.”

In March, XPhyto received two critical regulatory approvals in Europe to open the door for sales of its rapid, point-of-care COVID testing solution. On March 10, the company announced approval for commercial production under internationally agreed-on ISO 13485 quality standards (https://ibn.fm/qZCXm). On March 18, the company further announced Covid-ID Lab’s approval for in vitro diagnostic device (CE-IVD) use (https://ibn.fm/PqsZI).

On March 4, XPhyto announced completion of a corporate rebranding initiative that includes the launch of a new website.

“The company is excited to introduce a fresh look at such a pivotal point in our business growth,” Rogers added (https://ibn.fm/A4hzB).

XPhyto is on track to launch sales and distribution in Europe in April, and the company is also in talks with potential distribution and wholesale partners in the Middle East.

XPhyto intends to continue its rapid, point-of-care product development to target other pandemic-potential illnesses, such as H1N1 (swine flu) and H5N1 (avian flu), as well as a variety of other bacterial and viral infectious diseases. New products under an expanding portfolio could be launched before the end of the year.

XPhyto’s research and development operations are located in North America and Europe, but the company’s focus is the European market during these initial stages of product placement.

For more information on XPhyto Therapeutics, visit the company’s newly designed website at www.XPhyto.com.

NOTE TO INVESTORS: The latest news and updates relating to XPHYF are available in the company’s newsroom at https://ibn.fm/XPHYF 

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