The Germans call it COVID-19 “rapid testing mania”. But like most manias, it has opened up a Pandora’s box of problems.
As the speed of the vaccine rollout program falters in Europe, on-the-spot antigen testing continues to be the go-to screening process for millions of people every day in factories, offices, schools, daycare centers, and so on. This is because the laboratory-based gold standard for testing for coronaviruses – PCR (molecular) analysis – has a slow turnaround time in the order of hours to days.
Unfortunately, antigen tests can be highly inaccurate, causing some COVID-19-infected people to test negative and unwittingly become “super-spreaders”.
Now the solution for medical practitioners in Germany has arrived with the innovation of super-fast, point-of-care PCR testing – making fast, highly-accurate testing possible in a diversity of real-world settings. It effectively decentralizes the whole testing process, making it logistically possible to provide on-site testing and results at many locations simultaneously.
XPhyto Therapeutics (CSE: XPHY) (FSE: 4XT) (OTC: XPHYF) and its German distribution partner Max Pharma GmbH have just begun marketing XPhyto’s “Covid-ID Lab” test system across Germany.
This breakthrough test is now registered within the European Union as a commercial in-vitro diagnostic (CE-IVD) test. It was developed as a collaboration with Stuttgart-based 3a Diagnostics GmbH – a world-leader in developing disease-detecting medical innovations.
The product essentially combines the accuracy of PCR testing with the speed of disposable screening tests, which represents a major innovation within this sector.
According to XPhyto’s German COO, Wolfgang Probst, Covid-ID Lab’s differentiating appeal is that it is highly reliable, easy-to-use, rapid, and convenient. It is also cost- competitive, which should give it widespread commercial appeal.
Probst explains why his company’s technological breakthrough is so disruptive: “Covid-ID Lab provides diagnostic level accuracy in minutes at the point-of-care. It is a specialized product that is designed to fill the market gap between disposable antigen tests and centralized automated PCR systems.
Examples of target customers are airports, cruise lines, pharmacies, medical clinics, and any industrial or education site that requires rapid, definitive results.”
Covid-ID Lab is especially well suited to transportation hubs, border crossings, care facilities, schools, pharmacies, cruise ship terminals, and hospitality settings – particularly venues where space is at a premium and testing turnaround times need to be especially fast and results reliable.
Probst adds, “It is also ideal for pop-up testing centres. In fact, with our technology, we expect to be able to run small satellite labs. This opens up many potential testing labs throughout Germany.”
The company anticipates that COVID-ID Lab will become a valuable coronavirus diagnostics tool in Germany. Which is because the global threat of COVID-19 and its variants, as well as other similarly infectious viruses, will continue to lurk in the shadows for the foreseeable future, according to medical experts.
Why Covid-ID Lab is a Game Changer
XPhyto is clearly in the early stages of a successful product launch – one that could have the disruptive effect of making rapid PCR testing available for use in a diversity of point-of-care settings.
This could go a long way towards normalizing economies in Germany and elsewhere in the EU as countries attempt to loosen restrictions while keeping the Covid-19 pandemic under control.
Now that there is a distribution agreement with a leading German medical wholesaler in place, XPhyto is getting the kind of validation in the medical media that bodes well for COVID-ID Lab’s commercial viability. This comes in stark contrast to all the negative publicity that antigen tests have received.
Probst explains why Covid-ID Lab is the solution to problematic antigen tests.
“Our tests find coronavirus-infected people before an antigen test can, which only kicks in when a higher viral load is reached. As a result, many people with the disease have a negative test, feel safe, go shopping and spread the virus in the process.
With XPhyto’s test, the genetic material of the viruses is amplified to such an extent that SARS-CoV-2 can be detected even if only small amounts are present. This is how PCR works and why it is the diagnostic standard.”
What’s most problematic about conventional, laboratory-based PCR testing is the need for both expensive centralized and automated equipment and skilled technicians which means four hours to a couple of days to generate definitive results. It is also pricey (ranging between the euros 40-120 per test). Additionally, testing capacity throughout Europe has been seriously constrained by backlogs.
Other Key Developments for COVID-ID Lab
A leading Frankfurt area pharmacy -- Spitzweg Apotheke, -- is already pioneering the adoption of COVID-ID Lab – which is administered by health care professionals to patients on-site at one of its clinics.
Gabor Perl, who runs the Spitzweg pharmacy, says: “We are pleased to take part in this pilot project and now offer our high-risk-group customers access to a rapid PCR test with immediate results. We believe this is an opportunity for best-in-class healthcare delivery.”
The rollout of this disruptive point-of-care testing to other pharmacies is expected to be key to XPhyto’s future success in this market segment. Pharmacy owners will surely be impressed with the fact that COVID-ID Lab can be adapted for use with standard PCR instruments, while testing clinics will not need to purchase any new equipment to use the tests.
Data from the Pharmaceutical Group of the European Union suggests that there are nearly 100,0000 pharmacies in the EU, which leaves a very large potential addressable market beyond Germany.
XPhyto is also exploring a product rollout in Israel (a global leader in the fight against COVID-19) and other Middle Eastern nations. The company says that more details are coming soon.
Investment Summary
PCR testing for coronaviruses is here to stay, according to some health care industry experts. At the very least, it will remain our most effective tool for years to come for monitoring transmission, regardless of how many people are vaccinated this year.
Some experts predict that the EU and North America will never achieve full immunity and that COVID-19 may become a seasonal virus – like influenza – because the reinfection of coronaviruses is common.
According to Professor Ali Mokdad from the
Institute for Health Metrics and Evaluation (IHME) at the University of Washington, “We’re not going to reach herd immunity. It’s going to be seasonal, and it’s going to be like the flu, and we’re going to need to be ready for it.”
It is therefore no surprise that the market for coronavirus testing is growing exponentially. By the estimation of Allied Market Research, it is likely to grow by almost 9% per annum until 2023, swelling to $39.1 billion.
The key takeaway here is that the widespread adoption of ultra-fast, ultra-reliable PCR testing at a wide diversity of point-of-care settings, including pop-up facilities, could be critical to helping break the chain of transmission. It will also prove helpful in monitoring the effectiveness of the vaccines that are being widely administered in Europe and North America.
XPhyto Therapeutics has demonstrated the German-made technological knowhow to innovate a PCR test kit that could become highly disruptive due to its speed – only 25 minutes – and the reliability of its molecular testing PCR methodology in real-world settings. This means that XPhyto is ideally positioned to earn a meaningful share of the PCR diagnostics market in the EU and the Middle East.
Company CEO Hugh Rogers says that the rapid, successful development of COVID-ID Lab speaks to XPhyto’s ability to successfully innovate breakthrough technologies on an aggressive timeline.
“For the company, it demonstrates we can advance a product from concept to prototype to validation and ultimately commercial approval in less than 12 months. This a major accomplishment and bodes well for our development pipeline of medical diagnostics and drug formulation products.
For patients, COVID-ID Labs offers patients real-time, reliable on-site testing results. This translates into an innovative and potentially powerful tool for clinicians and healthcare providers in the global management of SARS-CoV-2.”
Thanks to the company’s highly disruptive PCR technology and its innovative drug delivery formulations that it also intends to commercialize this year, XPhyto will be a stock to carefully watch in 2021. This promises to be a breakout year.
ABOUT THE AUTHOR: Marc Davis has a deep background in the capital markets spanning 30 years, having mostly worked as an analyst and stock market commentator. He is also a longstanding financial journalist. Over the years, his articles have appeared in dozens of digital publications worldwide. They include USA Today, CBS Money Watch, The Times (UK), Investors’ Business Daily, the Financial Post, Reuters, National Post, Google News, Barron’s, China Daily, Huffington Post, AOL, City A.M. (London), Bloomberg, WallStreetOnline.de (Germany) and the Independent (UK). He has also appeared in business interviews on the BBC, CBC, and SKY TV.
Marc is also an enthusiastic investor in XPhyto Therapeutics and his commentary is not intended to be a solicitation for other investors to purchase this stock. Investors are always advised to consult an investment advisor before making investment decisions.
FULL DISCLOSURE: Xphyto Therapeutics is a client of Stockhouse Publishing.