Alex Sheppard and Dr Mona Kab Omir founded the successful KnowNow Spike Protein Infectiousness test which is UK developed, patented, designed and manufactured.
They were founding members of the UK Government’s Project Moonshot COVID-19 recovery team and have set up the health tech company Vatic.
Health Tech World spoke with the founders as they prepare to present evidence that suggests KnowNow has been highly accurate against mutations at clinical trials.
What is KnowNow and how does it work?
The Vatic KnowNow Spike Protein Test is an on-the-spot COVID-19 infectiousness test that looks for the ‘live’ SARS-CoV-2 virus and returns a result within 15 minutes whether a person is currently able to infect someone else with COVID-19.
The test searches for the spike protein on the virus, which the virus uses to infect human cells. It is effectively mimicking a human cell to determine whether or not a person is infectious.
How accurate is it?
Unlike other tests, KnowNow won’t deliver a positive result if a person has been exposed to COVID-19 in the past but is no longer infectious.
Designed to avoid false positives, KnowNow is one of the most specific COVID-19 assays in the world (100% clinical specificity, (95% confidence interval 97.0-100% from clinical study of 441 specimens) and 0 false positives from 700 negative samples in clinical and analytical studies in clinical trials).
Our sensitivity is 95.6%, which consistently performs well against other COVID-19 tests, making us one of the most sensitive tests available.
Why is KnowNow better than other lateral flow tests?
KnowNow has been built in a different way to other COVID-19 lateral flow tests. It is an infectiousness test that detects the ‘live’ virus rather than simply identifying the presence of virus particles.
Where most people are negative, even a low incident of false positives can create large-scale disruption as people have to isolate when they don’t have COVID-19.
Because of the way that KnowNow detects the virus using the spike protein, it is well placed to work against mutations. We are currently validating this with an independent body, but our initial studies suggest that KnowNow works on all variants of concern.
Fast and accurate testing with a proven ability to withstand new mutations will take a primary role in preventing the economic disruption of unnecessary isolation in this crucial season.
Why is KnowNow better than using PCR tests?
KnowNow determines whether an individual is infectious, whereas PCR tests detect the virus long after the infectious period – up to 17 days after they have stopped being able to infect others.PCR tests are expensive and require laboratory processing, creating a time lag before results return. In contrast, KnowNow takes just 15 minutes for the result to show up.
PCR still has its place but it is important that we have a wide variety of options to combat the spread of COVID-19.
Experts have warned that lateral flow tests have too high a false positive rate to replace laboratory ones. So why does Vatic think differently?
Our lateral flow test is not designed to replace laboratory testing. Lab tests help build up a ‘complete’ picture of COVID-19 prevalence and transmission. Lateral flow tests are designed to quickly identify infectious people so that they can avoid infecting anyone else.
Our KnowNow lateral flow test is a much better solution for everyday workplace and community testing because it is cheaper, easier, and doesn’t require a laboratory on-site.
Does KnowNow identify COVID-19 infection in people who have no symptoms?
Yes. The test is sensitive enough to identify infectious people even if they have no COVID-19 symptoms, before they’re at a high risk of infecting others.
Between 40-45 per cent of those infected with COVID-19 do not develop symptoms, and studies suggest that these people can infect others for an extended period, perhaps longer than 14 days.
Where does testing sit with the vaccination programme?
Vaccines are a key part of the fight against COVID-19 but, to fully eliminate the virus, we need to use all of the tools at our disposal.
COVID-19 and mutations will continue to spread and in fact, COVID-19 is likely to be around for the rest of our lives.
Not everyone will accept or be able to have the vaccine, and vaccinated people can still catch the virus and spread it to their friends, family or colleagues, particularly within indoor settings.
No one knows if the current vaccines will work effectively against future mutations of the virus. Even if they do, people will still require regular vaccine ‘boosters’ – hugely expensive Government programmes that are unlikely to be freely available to everyone indefinitely.
Mass testing remains vital to COVID mitigation. It can quickly identify outbreaks of the virus, which is fundamental to keeping its spread under control, ensuring that hospitals don’t become overwhelmed by new cases, and reducing the economic damage and disruption caused.
What should people do if they test positive using KnowNow?
Following a positive result, people should follow the current government guidance, including self-isolation and reporting the result to the NHS and their employer.
We have built an app to support the recording and reporting of KnowNow tests. Once the test is done, it produces an encrypted QR code that people can use as part of a passporting system, allowing those with negative results to access services or workplaces.
It’s designed to ensure that people don’t have to give away too much health or personal data, while Vatic doesn’t collect or store any of the data generated or transmitted via the app.
Who can administer the KnowNow Test?
So that the test is used as effectively as possible, it currently needs to be administered by a trained professional.
We are in the process of trialling and seeking approval for a variation of the KnowNow Test which could be administered by individuals themselves.
Why is it so important that businesses run their own COVID-19 testing programmes?
On a macro level, the economy, public health, and society can cope with a low level of Covid-19 community transmission, especially once the vast majority of a local population is vaccinated.
But for an organisation, even a low level of transmission is potentially disastrous – it will mean multiple people forced to take time off work and the possibility of serious business interruption.
As we’re eventually likely to see a decline in mask-wearing, PPE, distancing and extra hand-washing in offices in 2022 , businesses that don’t run testing programmes will have precious few preventative options open to them.
What approvals has the KnowNow test had?
The KnowNow test is currently undergoing global trials to finalise approvals with both the DHSC in the United Kingdom and the FDA in the United States.
The test has received CE Mark status for professional use within a healthcare context and is registered with the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
Can KnowNow be manufactured and used outside of the UK?
It is currently waiting for FDA approval in USA.
We are also currently carrying out a 650+ patient clinical trial with sites in the UK, USA and Brazil to provide us with a higher volume of clinical data and with a view to additional regulatory approvals to widen the reach of the impact we can have globally in pandemic recovery.
The KnowNow test is registered for use in the EU.
The future – What are Vatic Health doing beyond COVID-19?
The unique chemistry we used within our COVID tests can be applied to detect other biomarkers. We are currently scaling our capability to look at a wider number of biomarkers simultaneously.
Our vision is to enable acute disease to be identified earlier, or pre-emptively, to enable faster treatment for more people.
Vatic Health is a young business and our co-founders, Alex Sheppard and Dr Mona kab Omir have been working in close collaboration for three years now on predictive testing and tracking for the key ‘biomarkers’ which indicate acute disease incidence. Our work on bio-marker inflammation testing before COVID meant that we were rapidly able to respond to the pandemic.
COVID has accelerated the pace of the business due to the huge level of global interest in developing effective on-the-spot testing. To date, Vatic Health has raised investment from leading investors, including LocalGlobe and Hoxton Ventures.
The company has also been supported by Entrepreneur First, the Oxford Foundry and Innovate UK, and was a founding member of the UK Government’s Project Moonshot COVID-19 recovery team.
