XPhyto Therapeutics has announced its ability to significantly speed up testing for COVID-19 using widely available PCR equipment.
As vaccines begin to roll out in a patchwork fashion, the advent of rapid, definitive testing for COVID-19 in strategic and convenient point-of-care settings is critical to defining 2021 as the year that we bring the pandemic under control.
Much to everyone’s surprise, a small Canadian life sciences company has become a frontrunner in the race to commercialise such breakthrough technology by teaming-up with a German diagnostics firm.
Vancouver-headquartered XPhyto Therapeutics Corp. has just announced its ability to significantly speed up testing for COVID-19 using standard PCR equipment found in analytical laboratories, hospitals and a diverse range of point-of-care settings.
The world needs faster definitive diagnostics. Especially in light of how antigen testing – the go-to rapid testing method of choice until recently for health authorities throughout the world – has fallen out of favour.
This breakthrough concerns the announcement of successful trial validation results for XPhyto’s proprietary rapid PCR test kit. This innovation is a collaboration with Stuttgart-based 3a-Diagnostics GmbH, which has plenty of expertise in developing diagnostics for infectious diseases.
XPhyto’s announcement attests to the completion of successful validation trials, which demonstrated diagnostic-level sensitivity and specificity for the test kit. (Further specifics about these results and the trial methodology involved are expected to be announced soon.)
However, it is not the high degree of accuracy that really sets the test apart; instead, it is the ability to shorten testing turnaround times from at least a few hours to as little as 25 minutes.
XPhyto’s CEO, Hugh Rogers says his company next intends to apply for a regulatory approval first in Germany, while also gearing up for a near-term commercial launch in early 2021.
Why is this PCR test kit so disruptive?
What is particularly disruptive about the new test kit is that it acts as a turbo charger for existing PCR testing equipment because it’s fast and requires minimal laboratory processes which could dramatically speed up testing turnaround times. This makes the test particularly well suited to mobile, satellite, or ‘pop-up’ labs.
PCR is an acronym for ‘polymerase chain reaction’ and is the gold standard for coronavirus diagnostics due to its reliability for generating accurate results. It involves detecting COVID-19’s viral genome markers by magnifying them millions of times with the kind of diagnostic equipment that is ordinarily only found in laboratories. However, less complicated forms of PCR testing are increasingly being made available in point-of-care settings – a process that XPhyto and 3a hope to speed up significantly.
XPhyto’s kit only requires a single PCR cycle that is complete in 20 minutes while most PCR test systems require at least an hour and sometimes several hours to complete a multi-step viral RNA amplification process.
XPhyto’s test kit also requires significantly less non-PCR laboratory processing time, including labour. Furthermore, it employs reagents that are readily available, whereas many PCR systems are presently dependent on reagents that are not available at this time or are only available in limited supply.
In essence, XPhyto and 3a could compress definitive diagnostic turnaround times from at least a few hours in a centralised lab (which usually takes 24-48 hours for results) to less than 30 minutes in a point-of-care “mini-lab”. This is very significant considering that the main bottleneck in the accurate testing for COVID-19 is the slow turnaround times for PCR tests – which typically range from a minimum of four hours to a maximum of one week.
Hence, the partnership’s timely innovation is expected to be welcomed with open arms by government agencies and healthcare providers who have been overwhelmed with long diagnostic processing backlogs involving millions of people.
Hailing the arrival of fast point-of-care portable PCR testing
As mentioned earlier, the medical community is now presaging into action a new generation of less complicated, portable PCR testing machinery that can be used in a wide enough range of point-of-care settings to allow for the inexpensive testing of vast numbers of people.
These point-of-care settings typically include clinics and doctor’s offices. Other environments that are ideal for such usage include transportation hubs, industrial facilities, hospital triage settings, and mobile sample collection sites.
Hence, the exclusive partnership is targeting the commercialisation of the test kit in Q1 of this year to capitalise on its ideal suitability for use in point-of-care and portable PCR technology, according to Rogers. This is predicated on the assumption that regulatory approval will be forthcoming in Germany, as well as in the rest of the European Union (EU).
Rogers says he is confident that XPhyto can meet all the regulatory requirements for a commercial product launch within several months. The company anticipates filing the “CE” certification in Germany in January, which demonstrates conformity with health and safety regulations for commercial diagnostic products manufactured within the EU.
The anticipated granting of this regulatory thumbs-up from Europe’s health regulators will likely be followed by an application for approval from Health Canada and the Food and Drug Administration (FDA) in the US.
A first-to-market entrant opportunity
Health authorities in recent months have come to rely on rapid antigen tests as a relatively inexpensive screening tool for mass testing in non-laboratory settings. But their lack of accuracy is causing these tests to fall out of favour. Some North American health authorities have even banned their use.
As a result, health authorities are left scrambling to find a new and more accurate frontline tool than antigen screening. It cannot be overstated that the medical establishment’s decision to bring scaled-down, portable PCR testing to the people will prove to be a major advancement in the battle to contain COVID-19 and in future pandemic scenarios. Community-based PCR testing promises to be the way forward, instead of the current overreliance on expensive, labour-intensive, central laboratory-based PCR testing, which is hampered by slow turnaround times.
XPhyto’s CEO thinks that the ubiquitous adoption of PCR technologies with a very fast turnaround in point-of-care settings could prove crucial to containing the pandemic throughout 2021. Especially considering that the expected vaccine rollout will not be consistent from country to country or even between different demographics within a single country.
As well as being a co-developer of this PCR test kit technology, XPhyto has exclusive marketing rights to its commercial launch. Accordingly, the company stands to benefit from access to a multi-billion-dollar marketplace in the EU and subsequently in North America.
Sceptics may argue that the advent of at least three effective COVID-19 vaccines being commercialised in 2021 will solve all of our problems, negating any further need for testing large numbers of people. However, this view overlooks the fact that there are going to be massive logistical challenges to inoculating up to eight billion people, maybe twice a year, on an ongoing basis. Full scale adoption of a vaccine – just in the developed world alone – may take many years.
Furthermore, studies show that there still remains considerable skepticism among at least a third of the populations in North America and Europe about the safety of any vaccines that are being rushed to market. Also, testing will be required for at least several years to monitor the success of these new and novel vaccines.
This helps explain why capital markets analysts following the health care sector estimate that the rapid diagnostic testing marketplace will be worth as much as US $40 billion by the end of 2022.
Breaking the chain of contagion
As countries tentatively re-open their economies, there is growing consensus that on-the-spot testing on a massive scale will be required to keep economies open while still protecting the world’s population.
Some of this will take the form of expanding PCR testing into point-of-care settings with new technologies that allow for super-fast turnarounds. XPhyto and 3a are certainly at the forefront of this much-needed strategy.
Keep in mind that it may take up to several years (or longer) for COVID-19 vaccines to roll-out, or to even earn widespread public acceptance. Until then, fast PCR testing in point-of-care settings promises to become a profound game-changer in the epic struggle to quell the global pandemic.