A novel rapid, point-of-care stroke diagnostics tool claims to shave 100 minutes off the current treatment pathway, potentially saving lives, reducing the chance of disability and saving healthcare providers and the wider economy $60,000 (£47,000) per year.
Globally, there are more than 20 million strokes each year.
In 2020, strokes caused 375,000 deaths in the EU and by 2035 this number is expected to rise by one-third.
Despite stroke being one of the leading causes of death in the UK and contributing an annual cost of £25.6 billion to the economy, stroke care research and investment have not received the same level of attention as other healthcare areas.
In fact, the amount of money invested in stroke in the UK is four to five times less than other diseases.
But with the rising prevalence of the condition and the need for more efficient and accurate diagnostic tools, there is an increasing urgency to address critical flaws in the care pathway.
Traditional stroke diagnosis methods often involve time-consuming and costly imaging techniques, causing delays in the initiation of treatment.
The discovery of LVO as a particularly damaging cause of ischemic stroke in 2016 revealed a further need for diagnostics tests that can guide paramedics to the correct facility.
In the case of an LVO stroke case, a thrombectomy – surgery to remove a blood clot – is needed within 24 hours after a stroke, but its effectiveness is greatest during the first six hours.
Access to thrombectomy centres in the UK, however, is limited.
There are just 24 hospitals with thrombectomy centres across the entire country and many of these operate only within working hours.
As a result, most patients are identified at a non-specialised hospital and need a secondary ambulance transfer to access thrombectomy treatment.
This causes the majority of LVO patients to miss the treatment window.
The limited availability of hospitals that can properly identify and treat an LVO has created a postcode lottery in stroke care.
Currently, patients’ chances of surviving a stroke can vary depending on where they live, with rural areas, in particular, facing challenges due to limited access to these vital centres.
One UK company formed by former students of Cambridge Univerity are leveraging advanced biomarker technology to streamline the process of getting patients to the correct facilities when it matters most; in the ambulance.
Speaking to Health Tech World, Upfront Diagnostics CEO and co-founder Gonzalo Ladreda said: “The problem is that if we look at the rates of thrombectomy in places like London, they are pretty good.
“They are at 9 per cent of patients admitted for ischemic stroke.
“But then if you look at eastern England, we are at 0.4 per cent.
“The problem is that although there are many patients that are eligible for thrombectomy, they are not arriving on time to those centres.
“Also, most of them close after half past 4 in the afternoon, which means that they don’t need to refer you to a different region in the UK, which involves an ambulance.”
The emerging potential of biomarkers
Since discovering and validating several novel blood biomarkers to detect LVO stroke cases, Upfront Diagnostics has developed a point-of-care test that can identify these biomarkers within 15 minutes.
The blood test, named LVOne, allows paramedics to recognise LVO stroke cases in the ambulance and take patients directly to a comprehensive stroke centre for treatment.
The impact of such a rapid test could be huge.
The test involves first pricking the patient’s finger to obtain a blood sample which is combined with a buffer in a handheld test, similar in appearance to lateral flow tests used for COVID-19.
The test detects specific molecules related to blood clots, allowing paramedics to make the decision on whether to transfer the patient directly to a thrombectomy centre.
The company claims this can save more than 1 hour and 30 minutes compared to the current clinical pathway.
Validation studies of LVOne have shown an accuracy rate of 95 per cent.
This significantly outperforms the current stroke scales used by paramedics, which although relatively specific, have only around 10 to 20 percent sensitivity.
Stroke treatment is time-sensitive and every minute counts.
For every 10 minutes saved after a stroke occurs, the chance of disability for the patient reduces by 2 per cent.
The LVOne test’s ability to shave off more than 100 minutes in the treatment process can potentially translate to a 20 per cent reduction in the chance of experiencing a debilitating stroke.
“Apart from the reduction of disabilities, is also access to thrombectomy,” Ladreda said.
“Currently, in the UK, only 3 per cent of patients receive thrombectomy.
“Based on our calculations, based on our accuracy, these numbers will increase drastically with the implementation of a system to reduce time to treatment.
“There are many patients that are eligible – around 10 per cent of patients are eligible [for thrombectomy], but last year only 2.8 per cent received it.”
Costs savings of £47,000 per patient
The NHS is facing huge financial challenges as it also wrestles with overcrowded emergency departments and a crippling workforce shortage.
Access to ambulances is a major issue that has captured public attention recently.
A chronic lack of available ambulances means the NHS is spending over £1m every week on hiring private ambulances.
“There are many players that are involved in the stroke pathway and the NHS is going through huge issues financially, like almost every healthcare system in the world,” Ladreda said.
“There are just not enough ambulances available, so the NHS needs to hire them.
“What we can do by being more efficient is reduce all these unnecessary transfers, as well as reduce carbon footprint.”
The estimated 7,000 eligible patients that do not receive access to emergency thrombectomy inevitably spend more time in the hospital following a stroke.
This incurs further costs for the NHS.
The financial implications extend to the wider economy. Around 90 per cent of stroke patients work.
“Not only will they not be able to work, but those families will need to take care of that person,” Ladreda added.
“So there is a cost for the health care system, for the government well, as well for those families.”
By saving those vital minutes after a stroke with a quick diagnosis, Upfront Diagnostics hope its point-of-care test will help bring about substantial cost savings, estimated at $60,000 (£47,000) per patient.
Getting LVOne into the hands of paramedics
Last month, Upfront Diagnostic announced a seed funding round of £1.6m, led by APEX Ventures’ Medical Fund and following grant funding of £799k from SBRI Healthcare in partnership with the Stroke Association
The company’s successful funding round represents a significant milestone.
The company plans to scale up its manufacturing capabilities in the UK and initiate a clinical study at four hospitals in Newcastle and Northumbria, aiming to validate the test with real patients.
The company then aims to obtain CE mark approval, facilitating access to the European market, and is also exploring expansion opportunities in the US.
Ladreda said the company is “poised to transform stroke diagnosis worldwide” and contribute to the larger goal of reducing the devastating impact of this silent epidemic on patients and society as a whole.
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