To date we have conducted three clinical studies. The first was a UK Government-supported National Institute for Health Research (NIHR) study across ten UK hospitals; the second was with Liverpool School of Tropical Medicine, and the third is a community study that we have led ourselves. We have also carried out our own analytical assessments, as well as two Public Health England analytical assessments.
We have worked with over 280 negative patient samples and around 100 COVID-19 positive patients across our studies. 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 KnowNowᵀᴹ test has been developed to Vatic's stringent standards of quality and safety.
It has undergone the necessary clinical trials and performance tests and has been shown to meet the specific requirements published by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).
The KnowNow test has been CE marked for professional use in a healthcare setting and has been registered for use in the UK and the EU.
So that the KnowNowᵀᴹ Test is used as effectively as possible, it currently needs to be administered by a trained healthcare professional.
A trained healthcare professional is defined by the Medicines and Healthcare products Regulatory Agency (MHRA) in the Target Product Profile for Point of Care SARS-CoV-2 Detection Tests as a professional belonging to one of the 10 health and social care professional bodies that are overseen by the Professional Standards Authority. You can find a list of these professions here.
However, since the KnowNowᵀᴹ Test needs just a saliva sample, it is much easier to administer effectively than other similar tests, and still return highly sensitive results. So we are investigating whether other specially-trained, competent individuals could be approved to administer KnowNow tests as well.
We are also in the process of trialling and seeking approval for a variation of the KnowNowᵀᴹ Test which could be administered by individuals themselves.
KnowNowᵀᴹ Tests should be stored between 2 and 30 degrees celsius, which means it's fine to store it at room temperature in the UK's mild climate.
There's no need to store it inside a fridge, unless you're expecting extremely hot weather. If you do choose to refrigerate the test though, just make sure it comes to room temperature before using it.
The KnowNowᵀᴹ Test device should also be stored still sealed in its foil pouch. Once removed from the foil pouch, it should be used within one hour.
We’re focused on developing our predictive health technology and tests so that we can make medicine more proactive and help to predict illness before it becomes acute or infectious. We want to empower people to feel in charge of their own health and wellbeing by making testing more readily accessible and available, allowing for earlier prediction and prevention of acute illnesses.
KnowNowᵀᴹ Tests have been invented, developed and manufactured in the UK.
What’s important when it comes to sensitivity is how much virus needs to be present in the patient sample for the test to give a positive signal. This is known as the 'Limit of Detection', and we measure this rather than clinical sensitivity as it is much more informative.
Our Limit of Detection is between 50,000 and 200,000 viral copies per mL, making our test more sensitive than other rapid antigen tests available. The Abbott BinaxNow test, for example, needs 1,000,000 viral copies per mL in order to get a positive signal.
The KnowNowᵀᴹ Test's low Limit of Detection means it can detect infected people as early as day 3 to 4 of infection. This is before they become highly infectious, and a day or two earlier than most tests available (based on models of viral load in disease progression).
If you'd like to read more about this subject, we recommend reading this paper. It argues that the "Limit of Detection matters and directly impacts efforts to identify, control, and contain outbreaks during this pandemic" since "higher LoD are likely to miss nonnegligible fractions of infected individuals." It also makes the case that Limit of Detection values for tests using universal standard metrics should be readily available in the public domain to enable like-for-like comparison.
At the moment, KnowNowᵀᴹ Tests are for professional use only, meaning that they need to be administered by a trained healthcare professional. This means that we can take orders from organisations that have in-house or outsourced healthcare professionals who can perform the tests, or testing service providers.
However, since the KnowNowᵀᴹ Test needs just a saliva sample, it is much easier to administer effectively than other similar tests, and still return highly sensitive results. So we are investigating whether specially-trained, competent individuals could be approved to administer KnowNow tests as well.
We are also in the process of trialling and seeking approval for a variation of the KnowNow test which could be administered by individuals themselves.
The KnowNowᵀᴹ Test and COVID-19 antibody tests test for completely different things.
Antibody tests identify whether someone has had coronavirus in the past, whereas the KnowNowᵀᴹ Test detects whether an individual is currently infectious.
Antibody testing involves detecting the immune response in the human body to having fought off a virus. These tests look for an antibody created in the bloodstream in response to the presence of a virus in that environment. This is useful when testing the effectiveness of a vaccine, or understanding how far and wide a virus has spread. However, it is of limited usefulness to individuals, as it is only able to identify whether an individual has fought off the SARS-CoV-2 virus in the past. It cannot effectively confirm whether they are currently infected, or infectious.
Vatic is a predictive health company focused on making medicine more proactive. We deliver on-the-spot tests which detect subtle biomarkers in people’s bodies to predict illness before it becomes acute or infectious.
Our first product is KnowNowᵀᴹ, a rapid turnaround COVID-19 antigen test, that is designed to identify COVID-positive people before they become highly infectious*, based on just a small saliva sample.
The expiry date of KnowNowᵀᴹ Tests will be clearly marked on their packaging, and you can expect the shelf-life of each box of tests to be at least four months.