First Saliva-Only COVID Test Receives UK Regulatory Approval

Vatic, a UK-based healthtech company, says its unique ‘on-the-spot’ saliva antigen test for COVID-19 has received UK regulatory approval with CE Mark status and has been registered with the UK Medicines and Healthcare Products Regulatory Agency (MHRA).

The easy-to-use saliva-only swab has been hailed as a ‘breakthrough’ in terms of comfort and convenience, compared to the more invasive nasopharyngeal or nasal swabs which are currently deployed in workplaces and schools.

The test, which provides results in under 15 minutes, could be a complete game-changer for UK businesses. The company is working with top UK and global consumer retail, transport and hospitality brands to pilot the technology in real-world environments.

Vatic’s test technology, called KnowNow, can identify people who are actually infectious, with results in approximately 15 minutes. The CE Mark registration enables the test procedure to be overseen by a healthcare professional.

KnowNow’s technology searches for the ‘spike’ on the virus as a measure of infectivity. Significantly, the detection methodology underpinning the test is immune to potential mutation of the virus, unlike tests based on antibodies. The test could be rolled out to open sectors of society that have been restricted or closed entirely since the start of the pandemic such as sporting events.

 

 

Alex and Mona first met in Oxford at the Queen’s College bar on the first day of the technology accelerator programmeEntrepreneur First in September 2019. They soon realised they had a common interest in this field and formed a company, raising funding from top tier London investors and grant support from the University of Oxford and Innovate UK. The scientists set about collaborating on predictive testing and tracking for the key ‘biomarkers’ which indicate potential acute disease incidence. They saw an urgent need for on-the-spot predictive screening for acute diseases, starting with COVID-19.

Alex Sheppard, Vatic CEO, and co-inventor of the technology, said, “CE Mark registration is a significant stage in rolling out this UK-based technology to help keep people safe and open closed sections of society. We are delighted to be trialling the technology with some of the UK’s most famous brands and institutions to help them keep their customers and employees safe.”  

Alex added, “We’ve seen in government-run studies that the accuracy of tests decline when experts aren’t involved. One reason is the sampling technique – it’s currently very difficult to get right and produce a good quality sample. The new generation of rapid antigen tests use saliva sampling – which is a lot easier to get right, a lot more comfortable so people will be more likely to comply, plus accuracy is less of a problem.”

“With the rise of multiple mutations across the world, vaccinations alone are no longer the silver bullet for ending the pandemic. Instead, regular testing and vaccine technologies are needed together to help reduce the overall spread and reopen society such as theatres, sporting and other cultural events, while helping to keep people safe from the virus. Regular, accessible COVID-19 infectivity screening is needed for us to do many of the things we are currently missing out on even with vaccines. Our much-loved social institutions and services can reopen safely such as schools, stadiums, airports, seaports, train stations, pubs and restaurants. Any company interested in trialling this technology please get in touch.

Vatic Co-founder, co-inventor of the technology and Chief Technology Officer, Dr Mona Kab Omir, said, “The more we can encourage and enable regular testing across the population – giving people clarity about whether they are infected (and, critically, infectious) – the quicker our lives will start to look more ‘normal’. Where a typical antigen test identifies the presence of harmless viral matter, our test identifies the infectiousness of the people who are tested. This is a much needed technological breakthrough where in public health in it is critical to delineate ” 

The CE Mark is a declaration that a medical device meets EU standards for health, safety, and environmental protection. The CE Mark is valid in the UK and permits the company to start manufacturing the test kits in a UK factory. The company is also undertaking a community study to validate the technology and recruiting entirely through social media.