A technological evolution – defined by speed and precision – could soon transform the US $84.4bn COVID-19 diagnostics market.
Vancouver-based life sciences company XPhyto Therapeutics Corp. expects its rapid COVID-19 test system to be approved in Europe by early March. The test kit provides results within just 25 minutes, which is significantly quicker than the rapid PCR tests that are already shaking up the market and are significantly more accurate than disposable antigen tests.
The company expects to be able to deliver on its first order of around 10,000 test kits before the end of March.
PCR test innovation
This innovative technology that was developed by XPhyto and its German partner, 3a-Diagnostics GmbH, could arm healthcare providers with a vital weapon when combatting the COVID-19 pandemic. It also has the potential to reinvigorate the global tourism, travel, and events industries as they bid to get back on their feet.
The speed and convenience offered by this test kit makes it exceptional within the diagnostic testing world. It essentially combines the accuracy of PCR with the speed of disposable screening tests, which represents a major innovation within this sector.
The test kit – called COVID-ID Lab – requires less equipment and training than conventional PCR kits. It comes with reduced operating costs and increased convenience and portability, so the team can target thousands of airports, cruise ship terminals, and pharmacies that currently lack this testing capacity.
Ushering-in the world’s fastest PCR testing
A European sales launch is slated for April 2021, with other jurisdictions to follow. The company’s partner, 3a – a firm with a strong track record in developing diagnostics for infectious diseases – expects approval as a medical device manufacturer within several weeks.
The next step is to launch commercial sales of COVID-ID Lab. Already, XPhyto is organising commercial manufacturing and distribution agreements in Europe and the Middle East.
In fact, XPhyto has secured exclusive marketing rights for this commercial launch. To that end, the company has assembled a sales team consisting of “world-class clinical and pharmaceutical executives and service providers” to bring the right level of expertise to the task of rapidly rolling out COVID-ID Lab across the world.
“We are extremely fortunate to now have a team with deep expertise in medical diagnostic product commercialisation,” says Hugh Rogers, CEO of XPhyto.
“The team has extensive experience from regulatory approval to international production and sales. Our goal was to create the fastest and most portable COVID-19 PCR test on the market. We are confident in our prospects for expedited approval and look forward to commercial launch in short order.”
Why PCR testing will remain crucial for years to come
Let’s be clear: vaccines will not make COVID-19 testing redundant. It would be a mistake to think that.
Vaccines are being rolled out in some developed nations, but it will likely take years to inoculate enough people to build up herd immunity on a global basis. PCR testing will also be crucial in determining the efficacy of these vaccines, something that has not yet been demonstrated at scale.
These gold standard frontline diagnostics tools will therefore continue to be deployed for many years as humanity battles to stem the spread of COVID-19, and they are likely to be used to detect various other infectious diseases long into the future.
To that end, XPhyto and 3a are developing a portfolio of test kits designed to detect H1N1 swine flu, H5N1 avian flu, influenza A, and group A strep, as well as several oral health tests for stomatitis, periimplantitis, and periodontitis. Those additional test kits should be launched in Q4 2021.
COVID-19 now appears to be endemic. As the developing world battles to contain the virus, testing will play a critical role in containment at border crossings and transportation hubs indefinitely.
In other words, this is a solid, long-term, sustainable business. The coronavirus pandemic cost the global economy $11.7trn in 2020 alone, according to the charity, Oxfam. Governments will therefore be prepared to spend significant sums on testing in a bid to reopen their economies.
What makes this fast PCR technology so disruptive?
It bears repeating that this technology appears to be especially disruptive because of its convenience, speed, and accuracy. Hence, fast, point-of-care PCR testing could help pave the way for the travel, hospitality, and events industries to open again.
Additionally, the healthcare industry is on the hunt for robust, effective testing solutions that help workers to get on with their work as quickly, safely, and efficiently as possible. Because COVID-ID Lab is so fast and does not require a full-scale laboratory, it can be deployed in a diversity of point-of-care settings, including pop-up labs.
In particular, XPhyto has the opportunity to distribute the test in small venues like pharmacies or pop-up community-based testing facilities, which would not otherwise be able to use PCR testing due to logistical constraints.
The big question that remains to be answered is how accurate is XPhyto’s COVID-ID Lab? According to the company, it has exhibited a very high diagnostic level of accuracy in sensitivity and specificity. The company says it is looking forward to publicly divulging this sensitive data once it has commercial approval. That said, COVID-ID Lab is expected to easily surpass the threshold for accuracy in testing technology required by the World Health Organization, as well as by government regulators in North American and Europe.
As the co-developer of this pioneering technology (while also owing the marketing rights), XPhyto aims to become a major player in the rapidly expanding Covid-19 diagnostics market in the EU, and subsequently in North America.
One thing is for sure: the introduction of fast, convenient, ubiquitous PCR testing will be crucial to finally quelling the pandemic in 2021.