Presymptom Health, a ‘medtech company and pioneer of a portfolio of AI-driven early diagnostic tests for infection and sepsis’, has been selected to join the Innovative Devices Access Pathway (IDAP) pilot – a new pathway designed to ensure that technology is helping UK patients as quickly as possible.
Its participation in the programme will be focused on its infection diagnostic test, which it says can be used ‘at an early stage to rule out the presence of infection and enable clinicians to delay or eliminate antibiotic use’. Presymptom’s technology was developed via the application of machine learning and AI analytics to derive insights from a unique presymptomatic 72,000-sample biobank generated during a novel 10-year UK study. It explained: “This new test uses a technique called RNA-based host response analysis, which can find infections by looking at how cells react, even before an individual starts feeling sick – providing an early warning signal of infection, regardless of the specific germ causing it. This transformative host-response approach differs from traditional methods that focus on identifying the specific germ causing the infection. These take a long time to give results, aren’t always accurate, and often cannot distinguish pathogens from harmless microbial species. Due to these limitations, doctors may not know if an infection is present and how severe it may become. As a result, they may wrongly prescribe antibiotics – an issue that compounds AMR.”
Presymptom Health says its technology provides ‘early and reliable information’ about infection status in patients with non-specific symptoms, helping doctors make better treatment decisions. The test can be run on ‘ubiquitous’ NHS PCR platforms, widely deployed during the COVID pandemic, but – it says – ‘now often underutilised’.
CEO, Dr Iain Miller, pictured, said: “We’re confident our technology can not only save lives, but also help the NHS reduce costs and tackle AMR. The IDAP pilot will provide us with vital support and consultation to enable us to work with stakeholders to design an optimal adoption path that increases our chances of success, and ensures the technology gets into the NHS’s hands sooner. The support we receive will help us accelerate our development, not just in the UK, but eventually in the US and globally too.”
The science behind Presymptom’s technology is based upon 10-years’ work at Defence Science and Technology Laboratory (Dstl), and originated from £16 million of sustained Ministry of Defence investment in a research programme designed to help service personnel survive infection from combat injuries. The programme’s success enabled the commercialisation of Presymptom.
The company was created by scientists working at government laboratories, initially researching how to tackle biological threat infection, such as anthrax, plague and Ebola, all of which can cause death from sepsis. Ploughshare – the company that ‘finds new and inspiring uses for government inventions’ – identified the innovation as having potential societal impact, and spun it out from the UK Ministry of Defence.
Since its establishment in 2019, Presymptom has received seed funding from Ploughshare and the UK Innovation & Science Seed Fund to help accelerate its development.
The ambition of IDAP is ‘to support the rapid development of innovative technologies that can be introduced into the NHS to address unmet clinical needs for patients and healthcare professionals at the earliest opportunity, without compromising on standards of safety, quality, and effectiveness’. Presymptom Health joins just seven other companies for the IDAP pilot – a joint project between the Department of Health and Social Care, NHS England, NICE, the MHRA, Health Technology Wales (HTW,) and the Scottish Health Technology Group (SHTG). During it they will receive non-financial support from a team of experts that will help them develop their technology, and navigate regulatory and access barriers across product development.