Following the revelation that antigen tests are increasingly inaccurate, XPhyto Therapeutics have the solution, a point-of-care PCR test that yields results in only 25 minutes.
In Germany it has been called COVID-19 ‘rapid testing mania’, but like most manias the rush to expand rapid testing 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 and other key industries. The rise in independent rapid testing is a direct consequence of the fact that the laboratory-based gold standard for testing for coronaviruses, PCR (molecular) analysis, has a turnaround time of up to 24 hours or more, making it impractical for use in on-the-spot testing.
The continued popularity of rapid testing in Germany is a reflection of its efficiency in identifying those who are highly infectious, allowing them to isolate, reducing the spread of coronavirus. Unfortunately, antigen tests can be inaccurate, causing some COVID-19-infected people to test negative and unwittingly become ‘super-spreaders’.
There are now 15,000 pop-up testing centres across the country, funded by the government, who have spent hundreds of millions of euros on these impromptu centres, which include schools and day care centres. Self-administered antigen tests have become ubiquitous, now available at supermarket checkout stands, pharmacies, and even petrol stations. In the UK alone there has been in excess of 50 million rapid antigen tests conducted on school children so far this year. Furthermore, the British government has purchased nearly 400 million rapid antigen tests from Innova Medical Group, to enable the ongoing screening of adults in point-of-care settings. Germany and the UK are amongst a plethora of European countries who are relying heavily on testing, alongside vaccines, to beat the pandemic. However, the antigen test that these nations are relying on has now been branded as useless by the US Food & Drug Association (FDA), who have suggested that these tests no longer be used.
The future of rapid testing
So how do Germany, the UK, and further EU nations continue the roll out of rapid testing without the ongoing threat of generating significant false positive and false negative results? A small Canadian-German life sciences company has recently commercialised a potential solution to this conundrum. Vancouver-based XPhyto Therapeutics Corp. is now marketing a point-of-care PCR test system, making fast, precise testing possible in a diverse range of real-world settings. It effectively decentralises the testing process, making it logistically possible to provide fast, inexpensive, on-site PCR testing at multiple locations simultaneously.
This innovative screening product, known as COVID-ID Lab, is 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 developer of disease-detecting medical innovations. XPhyto COO Wolfgang Probst explains: “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. 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.”
Probst explains why Covid-ID Lab is the solution to problematic antigen tests saying: “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.”
COVID-ID Lab can be adapted for use with standard PCR instruments meaning testing clinics will not need to purchase any new equipment to use the tests and the procedure only takes 25 minutes, a significant improvement on the standard 24 hours. However, the test needs to be undertaken by healthcare professionals in comparison to antigen tests which can be self-administered. Therefore, pharmacies and pop-up centres are being targeted as ideal venues for this new form of super-fast testing that shows accurate results in minutes rather than hours or days.
Why rapid testing may be here to stay
XPhyto anticipates that COVID-ID Lab will become established as a vital coronavirus diagnostics tool in Germany and elsewhere in Europe for at least the next few years. This is in perspective with the advice of some medical experts who are cautioning that the global threat of COVID-19 and its variants, as well as other similarly infectious viruses, will continue to be prevalent in our society for the foreseeable future. In fact, PCR testing for coronaviruses is expected to remain our most effective tool for monitoring transmission, regardless of how many people are vaccinated this year, according to many infectious disease experts.
Some experts even 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.1 Professor Ali Mokdad from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington stated: “We are not going to reach herd immunity. It is going to be seasonal, and it is going to be like the flu, and we are going to need to be ready for it.”
The commercial potential of rapid testing
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 USD 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 could 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 fast speed, convenience and PCR accuracy. As Germany reopens, government health agencies insist that they will continue to rely on mass testing to ensure that anyone not yet vaccinated against the coronavirus is also not infectious, especially in the case of those who carry COVID asymptomatically. In order for this strategy to ultimately become successful in breaking the chain of transmission, on-the-spot testing will need to become more accurate and far more available in point-of-care settings than it is currently proving to be. XPhyto Therapeutics’ super-fast, portable PCR testing system could be a powerful tool in helping Germany to effectively manage the pandemic.
This article is from issue 18 of Health Europa. Click here to get your free subscription today.