XPhyto Therapeutics Corp (CSE:XPHY) (OTCQB:XPHYF) (FRA:4XT) is eying an initial sales launch in Europe of its coronavirus (COVID-19) RT-PCR test system (Covid-ID Lab) in April this year, it said Monday, reporting it has now established a commercial team.
Covid-ID Lab is said to be a rapid, accurate test and was developed by XPhyto's exclusive German diagnostics development partner, 3a-diagnostics GmbH (3a).
READ: XPhyto Therapeutics touts completion of European regulatory application process for rapid coronavirus test
3a is expected 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, the company told investors.
The market launch team consists of experienced and world-class clinical and pharmaceutical executives and service providers.
"We are extremely fortunate to now have a team with deep expertise in medical diagnostic product commercialization," Hugh Rogers, the CEO and director of XPhyto told investors in a statement.
"The team has extensive experience from regulatory approval to international production and sales. As we near expected regulatory approval, XPhyto's business is rapidly evolving from innovation to impact. We are working hard to put the company in the best possible position to execute on our business strategy."
Initial manufacturing of the test is planned for Germany with additional capacity in other jurisdictions to follow, while 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, it added.
The company noted it was not making any express or implied claims that the product can eliminate, cure or contain the pandemic.
Notably, XPhyto and 3a are also developing a portfolio of oral biosensor screening tests to detect bacterial and viral infectious diseases and XPhyto is planning the commercial launch of its first biosensor product in the second half of 2021, it added.
XPhyto Therapeutics describes itself as a "bioscience accelerator" focused on next-generation drug delivery, diagnostic, and new active pharmaceutical ingredient investment opportunities.
Contact the author at giles@proactiveinvestors.com