On February 22, 2021 XPhyto Therapeutics (XPHY.C) announced that it has fast-tracked the assembly of an elite commercial team to launch its point-of-care COVID-19 RT-PCR test system.
“PCR tests are used to directly detect the presence of an antigen, rather than the presence of the body’s immune response, or antibodies,” states Medical Device Network, “By detecting viral RNA, which will be present in the body before antibodies form or symptoms of the disease are present, the tests can tell whether or not someone has the virus very early on.”
Xphyto – a bioscience accelerator – has already completed validation of the Covid-19 PCR Diagnostic Test Kit.
The PCR test system demonstrated clinical accuracy in detecting SARS-CoV-2 RNA within 25 minutes, making it an ideal screening tool for international airports.
As a 2nd wave of Covid-19 sweeps across the globe, commercial product launch in Europe is planned for Q1 2021.
Nine months ago, there was optimism that a global vaccine roll-out could stop Covid-19 in its tracks.
“This virus can be cured,” stated The Conversation in May 2020, “Most infected patients develop antibodies. Coronaviruses mutate slower than viruses such as influenza. This is good news for an effective vaccine that may not require updating for quite some time”.
Early optimism for a vaccine “magic-bullet”, is fading.
“The rolling seven-day rolling average for new coronavirus infections has fallen by a staggering 43% in just two weeks,” reports Forbes, “but some experts predict “Covid-19 may become a seasonal virus, as reinfection of coronaviruses is very common”.
“COVID-ID Lab was developed by Xphyto’s exclusive German diagnostics development partner, 3a-diagnostics GmbH,” states XPHY, “Xphyto expects 3a to receive ISO (International Organization for Standardization) 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 market launch team consists of world-class clinical and pharmaceutical executives and service providers who bring the experience and expertise necessary to effectively and rapidly drive the commercialization of COVID-ID Lab”.
Collectively, the team brings decades of experience in the biotech and pharmaceutical industries, including:
- Executive leadership
- Business development
- Regulatory compliance
- Product launch
- International marketing
- International sales
- Production
- Quality assurance
- M&A (mergers and acquisitions).
Members of Xphyto’s team have led medical diagnostic company growth from inception to over 500 million euros per year in multinational sales.
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.
Initial 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 commercial launch of its first biosensor product in the second half of 2021.
Equity Guru’s Jody Vance recently spoke with Xphyto’s CEO and Director Hugh Rogers to get a bird’s eye view of the company, its portfolio and what the markets can look forward to over the next 12 months.
“The team has extensive experience from regulatory approval to international production and sales,” stated Hugh Rogers, CEO and director of Xphyto. “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.”
- Lukas Kane
Full Disclosure: Xphyto is an Equity Guru marketing client.
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