XPhyto Therapeutics (XPHY.C) and its exclusive German diagnostic development partner, 3a-diagnostics GmbH (3a), have announced they received their EN ISO 13485 certification for their rapid point-of-care, SARS-CoV-2 RT-PCR Test System (Covid-ID Lab test).
This certification is an important step and will allow 3a to distribute the tests upon receipt of CE mark approval, which they expect to receive this month. EN ISO 13485 is the internationally recognized European standard for quality control in the design and manufacture of medical devices, so receiving their certification from the ISO is an auspicious sign.
The Covid-ID Lab test takes approximately 25 minutes to return a result and is point-of-care, making it far quicker than many other PCR tests, which need to be delivered to labs before a result is returned, a process which can often take days.
“We are pleased to remain on schedule with the launch of Covid-ID Lab and will continue to move forward as efficiently as ever,” stated Hugh Rogers, CEO and director of XPhyto Therapeutics. “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.”
While vaccination rates are increasing, especially in Germany, testing for Covid-19 is still likely to play an important role in public health’s attempts to combat the novel coronavirus. Many countries, including Germany, require travelers to have taken a Covid-19 test within 48 hours of entry into the country. Some countries, like Canada, require a PCR test – which typically has to be sent to a lab – within 72 hours of entry.
The rapid response time of the Covid-ID Lab test, as well as the fact it is a point-of-care test, means this test could help travelers comply with a variety of Covid-19 testing regulations. The Covid-ID Lab test could also assist with rapid point-of-care testing when economies are attempting to open, and when countries are trying to resume large gatherings safely.
In February XPhyto placed an order of 9,600 individual tests from 3a, saying this order’s primary purpose is to provide potential German and international distributors and licensees and their respective government regulators with test samples for review and evaluation.
XPhyto’s launch target for sales is April 2021 and they are currently in discussion with distribution and wholesale partners in Europe and the Middle East.
The RT-PCR testing segment constituted over 75% of the global Covid-19 diagnostics market share, however, the global market is expected to reduce in the coming years due to increased vaccination for Covid-19.
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. They are also aiming to create other pandemic-related biosensors for H1N1 (swine flu) and H5N1 (avian flu).
The stock has fluctuated between $2.65 and $2.74 following the news.
Full disclosure: XPhyto Therapeutics is an Equity.Guru marketing client.