Test to identify Large Vessel Occlusion strokes
Pockit’s patented blood-based diagnostic “LVOne” identifies Large Vessel Occlusion (LVO) strokes within minutes, with 95% accuracy. This enables patients to be taken directly to specialist hospitals where they can receive urgent treatment. The test can increase a patient’s chances of complete recovery by 20% and saves 97 minutes of vital time on average.
Current means of identifying LVO strokes involve a brain scan and require a trained radiologist to interpret the results. Pockit’s test is the first of its kind, using a finger prick of blood, which can be drawn by a technician and does not require a specialist consultant. Its ease of use and cost-effectiveness means it is easier to implement in current healthcare systems than competitor technology.
If the test was to be adopted across the NHS, it could allow up to 15,000 LVO patients to receive urgent treatment as quickly as possible, improving their quality of life and having a direct cost-saving impact on the NHS.
"Long-term relationships between the public and private sector are paramount for the success of this type of project. The work with the AHSN allowed us to engage early with NHS stakeholders and to develop a product that fits perfectly into the NHS.”
A stroke due to the blockage of a large artery in the brain disproportionately affects people from poorer backgrounds. Without urgent treatment, LVO strokes create a large burden of death, disability, and care costs. Removing the blockage as quickly as possible (thrombectomy), gives the best chance of recovery, however, only specialised regional hospitals are trained to provide this treatment.
Currently, ambulance staff cannot recognise people with a large artery blockage and most patients are transferred to a specialist centre, following assessment at their local hospital. The delay in reaching a specialist hospital decreases the effectiveness of a thrombectomy.
If ambulances were able to diagnose an artery blockage immediately, they would be able to refer patients directly to specialist care and improve the chance of recovery. Additionally, this would save money and the time of healthcare staff.
Alternative ways to identify LVO strokes are often expensive, require specialist training, and do not always provide accurate results.
The Pockit test is the first of its kind and uses blood biomarking to identify LVO strokes within patients quickly. The test requires a finger prick of blood, drawn by a technician, and can identify an LVO with 95% accuracy. Its ease of use and cost-effectiveness means the device can be easily implemented into current systems.
The Pockit team began discussions of the idea with several hospitals in the UK and US in 2018 and have since worked full-time to develop the innovation.
95 prototypes have been developed and validated due to an SBRI Phase 1 contract, (funded by the AHSN NENC) conducted from January-June 2022.
Manufacturing of the test was to take place in January 2023, after securing £800,000 of private funding and £800,000 from an SBRI Phase 2. The SBRI Phase 2 was funded by NHS and Stroke Association.
Trials are expected to take place in May 2023 in Northumbria and Newcastle, with the aim of obtaining UKCA and CE Mark approval in June 2024.
Outcome/Impact (200 words) (For example patient, financial or economic impacts)
Introducing the Pockit test to the NHS, could allow up to 15,000 LVO patients to be directed straight to specialist hospitals and save vital time in the treatment process. By saving potentially 70-90 minutes of treatment time per patient, the Pockit test could increase their chance of a complete recovery by 20%.
This would directly impact a patient’s quality of life, by reducing their time in hospital and the risk of death and life-long disabilities. The test would also reduce the need for ambulance transfers, repeated brain imaging and the length of hospital stays, which has a cost-saving impact across the NHS.
As LVO strokes disproportionately affect people from disadvantaged backgrounds and marginalised communities, Pockit’s test would reduce the additional burden of disability for these individuals and their families. This would contribute to minimising health inequalities across the UK.
The benefits of using the device would directly affect patients and the NHS. First and foremost, the device improves patient outcomes and gives them a better chance of recovery. As the device identifies LVO strokes within minutes, patients can be treated with the most appropriate treatment, more efficiently.
The device would also ease the burden of care costs on the NHS, by reducing the various factors mentioned in the section above.
Competitors of the test are often costly and require extensive training or large changes to current processes. The benefits of introducing the LVOne test over competitors are that it is low-cost and requires minimal changes to the current system. The test can be used by a technician rather than a specialist consultant, easing the workload of the limited number of specialists in the UK and making the best use of their time.
The AHSN NENC provided funding for both the Phase 1 and 2 SBRI bids, which allowed the company to develop prototypes and manufacture the product.
The AHSN NENC will support the national adoption of the LVOne test by facilitating introductions to neighbouring commissioners from different ICSs. The team will also facilitate the LVOne onto a procurement framework such as the NHS Supply Chain.
The test has several challenges that it still needs to overcome before it can be implemented. This includes gaining regulatory approval, health economics analysis and validating the performance of the test in a prospective clinical study.
The implementation strategy will focus on early adoption in the North East region and later, national implementation with the support of the AHSN NENC.
The Pockit team will propose a region-specific service model to the North East and North Cumbria Integrated Care Board and relevant CCGs. To aid with implementation, an initial test price will be set which is within ambulance service budgets for 2024/25.
Pockit won an award at the Bright Ideas in Health Awards 2023 which will further assist in development of the product.
Technology has been validated in a clinical study in Newcastle where 270 patients were tested achieving 95% accuracy: Diagnostics | Free Full-Text | A Novel Combination of Blood Biomarkers and Clinical Stroke Scales Facilitates Detection of Large Vessel Occlusion Ischemic Strokes (mdpi.com)