XPhyto Therapeutics has developed an innovative, rapid COVID-19 PCR test that has the potential to completely transform diagnostics.
Picture this pleasing scenario: you are exiting an airport, just minutes after clearing customs, with a negative COVID-19 diagnosis in-hand and a spring in your step.
Thanks to XPhyto’s PCR testing innovation, this may no longer be a fantasy.
It seems that such a seamless screening process for “gold standard” PCR testing – with a turnaround of mere minutes, rather than hours – is tantalisingly close. In fact, this could soon be available in a diversity of point-of-care settings and transportation hubs across Europe, and without any need for laboratory processing.
A technological evolution such as this – one that is defined by speed and precision – has the potential to rapidly transform the US$84.4bn COVID-19 diagnostics market.
Vancouver-based, publicly traded life sciences company, XPhyto Therapeutics (CSE: XPHY) (FSE: 4XT) (OTC: XPHYF), is currently in the process of attempting to tap into this very lucrative marketplace.
The company’s prospects could get a big boost with the receipt of its ISO (International Organization for Standardization) 13485 medical device manufacturer’s approval for its super-fast PCR test kit known as COVID-ID Lab. ISO approval is expected imminently, and the final step towards European regulatory approval, which is known as a “CE” designation for a commercial in vitro diagnostic device, is expected later this month.
The test kit provides results within just 25 minutes, which is significantly quicker than conventional PCR tests that are currently employed around the globe. Subject to regulatory approval, the company expects to be able to deliver on its first order of around 10,000 test kits before the end of March.
Becoming a world leader in PCR test innovation
This innovative technology, developed by XPhyto in conjunction with its German partner, 3a-Diagnostics GmbH, could be a vital tool for healthcare workers in the armoury against COVID-19, and could offer the potential for use in the tourism, travel, and events industries as they begin to open up again in light of COVID-19 vaccination programmes.
The speed and convenience offered by the COVID-ID Lab makes the test kit exceptional within the diagnostic testing world by combining the accuracy of PCR with the speed of disposable screening tests.
The test kit requires less equipment and training than conventional PCR kits, and comes with anticipated reduced operating costs, as well as increased convenience and portability. This opens the potential for rapid testing in places such as airports, cruise ship terminals, and pharmacies that currently lack this testing capacity on-site.
Ushering-in the world’s fastest PCR testing
A European sales launch for the COVID-ID Lab is expected for April 2021, with other jurisdictions to follow, subject to regulatory approval.
The next step is to launch commercial sales of the test kit, and XPhyto is already organising commercial manufacturing and distribution agreements in Europe and the Middle East.
XPhyto has also secured exclusive marketing rights for the commercial launch, for which it 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 the test kit 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
Vaccines will not eliminate the need for COVID-19 testing. On the contrary, COVID-19 vaccinations are currently being rolled out in some developed nations, but it will likely take years to inoculate enough people on an annual or semi-annual basis in order to build up herd immunity on a global scale. Rapid PCR testing will be vital component in of this – helping to determine the efficacy of the COVID-19 vaccines.
These gold standard frontline diagnostics tools will therefore continue to be deployed for many years, and will likely be used to detect other infectious diseases long into the future. As COVID-19 now appears to be endemic, testing may play a critical role in containment at border crossings and transportation hubs indefinitely.
The coronavirus pandemic cost the global economy $11.7trn in 2020 alone, according to the charity, Oxfam. Governments are therefore likely to spend significant sums on testing in a bid to reopen their economies.
What makes this fast PCR technology so disruptive?
This innovative technology appears to be especially disruptive because of its convenience, speed, and accuracy, which could could help pave the way for the reopening of industry once again.
Additionally, the healthcare industry is on the hunt for robust, effective testing solutions that help workers to do their job 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 is targeting 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 diagnostic level of accuracy in sensitivity and specificity. The company will provide further detail of this sensitive data publicly once it has commercial approval. That said, COVID-ID Lab is expected to surpass the threshold for accuracy in testing technology required by the World Health Organization, as well as by government regulators in North America and Europe.
As the co-developer of this pioneering technology (whilst also owing the marketing rights), XPhyto Therapeutics aims to become a major player in the rapidly expanding COVID-19 diagnostics market in the EU, and subsequently in North America.
A testing kit for a variety of diseases
The benefits of this innovation do not just apply to COVID-19. XPhyto and 3a are also developing a portfolio of testing kits that will be 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, with the expectation for launch by the end of 2021.
Remember that the best source of information about the company is the company itself, SEDAR, or the Canadian Securities Exchange (CSE) profile pages for regulatory filings and news releases. This is where it trades under the symbol XPHY. XPhyto also trades on the Frankfurt Stock Exchange under the symbol 4XT and in the United States on the OTC Markets under the symbol XPHYF.