Highfield Diagnostics Ltd

Company description

Highfield Diagnostics develops a paper substrate using laser printing, which aims to diagnose a range of different conditions.

The company was registered in 2017, but since 2021 we have been trading, have received our first pre-seed investment and have secured access to University labs. We now have 3 employees and are building our pitch, capability and revenue to secure seed stage investment, likely by the end of Q2 2021. Highfield Diagnostics, HDx, is a spinout from the University of Southampton, focussed on developing rapid tests for a range of diseases and conditions using their patented technology for smart diagnostic sensing. The HDx mission is to bring to market a range of point-of-care, single use, 'here and now' rapid tests where patients can be diagnosed in a matter of minutes, for diseases such as TB and sepsis and monitored over the longer term for conditions such as dementia. Our philosophy is to keep the testing simple, local, available, reliable and cost-effective. During 2020/2021 the company focussed their attention on Covid-19 and developed a solution to implement rapid antigen-detection testing. Of critical importance, unlike other current rapid tests that look for the presence of antibodies produced in response to the virus, our test detected the presence of the virus itself. Antibodies will only be present in blood samples 7-14 days after infection, and there is a lack of consensus about the reliability or utility of such antibody testing for tracking, tracing and containing the pandemic. Our tests detected the presence of a virus-specific protein in swabs taken from the patient, and this is key to determining if the person is infected now, not some weeks ago. The test format is similar to that of the commonly available pregnancy test and the testing provides an answer within a short time of 10-15 minutes directly at the testing site (at the hospital, primary care, or patient's home): if the test shows a red line, the person is infected. The current testing regime, which also looks for the virus and is considered as the gold-standard, is the laboratory-based RT-PCR test. This multistep test requires first taking a swab at a designated test centre, its transport to a central testing facility, followed by a long testing procedure that might take more than one day. Furthermore, it is costly (£12-15 per test) and requires an expensive testing system (costing ~£20-30k), amounts well beyond the budgets in most developing nations, and skilled technical staff to perform the testing procedure. We trialled out tests using human samples and the results were very impressive, matching (and out-performing on occasions) existing commercial tests. We then decided to enter our test for the XPrize foundation, a charity that sponsors work in areas of clear humanitarian need. HDx made it through all the stages to the final, where we were one of five finalists, 1 in the UK and 4 in the US https: //www.xprize.org/prizes/covidtesting since 2021, when we received our pre-seed funding, we have been co-developing a range of other tests with the clear goal to bring our innovative solutions in multiplexed, high-sensitivity and semi-quantitative testing solutions to the market. :

The company was registered in 2017, but since 2021 we have been trading, have received our first pre-seed investment and have secured access to University labs. We now have 3 employees and are building our pitch, capability and revenue to secure seed stage investment, likely by the end of Q2 2021. Highfield Diagnostics, HDx, is a spinout from the University of Southampton, focussed on developing rapid tests for a range of diseases and conditions using their patented technology for smart diagnostic sensing. The HDx mission is to bring to market a range of point-of-care, single use, 'here and now' rapid tests where patients can be diagnosed in a matter of minutes, for diseases such as TB and sepsis and monitored over the longer term for conditions such as dementia. Our philosophy is to keep the testing simple, local, available, reliable and cost-effective. During 2020/2021 the company focussed their attention on Covid-19 and developed a solution to implement rapid antigen-detection testing. Of critical importance, unlike other current rapid tests that look for the presence of antibodies produced in response to the virus, our test detected the presence of the virus itself. Antibodies will only be present in blood samples 7-14 days after infection, and there is a lack of consensus about the reliability or utility of such antibody testing for tracking, tracing and containing the pandemic. Our tests detected the presence of a virus-specific protein in swabs taken from the patient, and this is key to determining if the person is infected now, not some weeks ago. The test format is similar to that of the commonly available pregnancy test and the testing provides an answer within a short time of 10-15 minutes directly at the testing site (at the hospital, primary care, or patient's home): if the test shows a red line, the person is infected. The current testing regime, which also looks for the virus and is considered as the gold-standard, is the laboratory-based RT-PCR test. This multistep test requires first taking a swab at a designated test centre, its transport to a central testing facility, followed by a long testing procedure that might take more than one day. Furthermore, it is costly (£12-15 per test) and requires an expensive testing system (costing ~£20-30k), amounts well beyond the budgets in most developing nations, and skilled technical staff to perform the testing procedure. We trialled out tests using human samples and the results were very impressive, matching (and out-performing on occasions) existing commercial tests. We then decided to enter our test for the XPrize foundation, a charity that sponsors work in areas of clear humanitarian need. HDx made it through all the stages to the final, where we were one of five finalists, 1 in the UK and 4 in the US https: //www.xprize.org/prizes/covidtesting since 2021, when we received our pre-seed funding, we have been co-developing a range of other tests with the clear goal to bring our innovative solutions in multiplexed, high-sensitivity and semi-quantitative testing solutions to the market.

Project impact

HDx FlowDx technology radically improves lateral flow tests through smart control of the fluid flow within the test, and we are preparing to commercialize this technology with partners such as Ahlstrom, AMS-Osram, Volition, Operon and Molbio as well as develop their own tests in areas such as TB, Asthma, and sepsis/pneumonia in collaboration with University-based partners and organizations such as Asthma UK. Furthermore, HDx was very pleased to be one of only 5 finalists in the 2021 X-Prize Covid-19 Rapid Antigen Diagnostics test competition, and the only one from outside the US.

During the last year of 2021, the company has been trading and secured contracts from a large EU-based company to use our proprietary printing process to manufacture test devices to validate their ongoing products. This is generating ongoing revenues, and is likely to remain a useful source of income for the next year. Our COVID test that was developed and trialled in 2020/21 was featured on local TV. while we were not able to go into production, and have no regulation or validation of these tests (yet), the news item was valuable for promoting our ongoing R&D in the area of rapid diagnostics development. We entered our test for the XPrize foundation, a charity that sponsors work in areas of clear humanitarian need. HDx made it through all the stages to the final, where we were one of five finalists, 1 in the UK and 4 in the US. more info at https: //www.xprize.org/prizes/covidtesting.

during the last year of 2021, the company has been trading and secured contracts from a large EU-based company to use our proprietary printing process to manufacture test devices to validate their ongoing products. This is generating ongoing revenues, and is likely to remain a useful source of income for the next year. Our COVID test that was developed and trialled in 2020/21 was featured on local TV. while we were not able to go into production, and have no regulation or validation of these tests (yet), the news item was valuable for promoting our ongoing R&D in the area of rapid diagnostics development. We entered our test for the XPrize foundation, a charity that sponsors work in areas of clear humanitarian need. HDx made it through all the stages to the final, where we were one of five finalists, 1 in the UK and 4 in the US. more info at https: //www.xprize.org/prizes/covidtesting

The platform flowDX has been produced using a laser-based manufacturing technique that allows the production of customised lateral flow devices for Multiplexed, Sensitive and Semi-quantitative diagnostic testing.