Upfront Diagnostics’ blood test to detect severe stroke enters last phase of clinical trials

Upfront Diagnostics, a healthcare company focused on discovering novel biomarkers that can be applied to medical diagnosis, has started the last phase of clinical evaluation of a point-of-care rapid blood test designed to rapidly identify when stroke is caused by a blood clot blocking a main blood vessel within the brain. This is known as large vessel occlusion (LVO).  

Globally, there are more than 20 million strokes annually. LVOs account for 30% of strokes but are responsible for 95% of disabilities and deaths. The chance of recovery is much improved if a treatment called ‘thrombectomy’ is performed within hours of symptom onset.

Speeding up treatment is challenging because LVO patients are hard to identify outside a hospital due to many other conditions showing similar symptoms, whilst stroke can also be caused by blockage of small blood vessels and bleeding from blood vessels, which are unsuitable for thrombectomy.

In the UK, currently, only 24 hospitals can treat an LVO stroke with a thrombectomy. As a result, most patients are identified at another hospital and need a second ambulance transfer to access thrombectomy treatment. Typically, this causes a 2-hour delay in treatment and reduces how well patients recover.

Earlier treatment produces significantly better outcomes and savings - over £60,000 are saved per patient.

By identifying Upfront Diagnostics biomarkers with a handheld blood test, paramedics may be able to recognise LVO stroke cases within 15 minutes and take patients directly to a comprehensive stroke centre for treatment. This should result in better patient recovery and lower costs for the health and care system. 

Upfront Diagnostics and Newcastle Stroke Research Group have taken a significant step towards enhancing stroke diagnosis by initiating a clinical trial involving over 500 patients across multiple hospitals. The Rapid Assay Diagnostic for Acute Stroke Recognition (RADAR) study is being conducted in Northern England with the support of SBRI Healthcare and NIHR Clinical Research Network at the Northumbria Specialist Emergency Care Hospital, Royal Victoria Infirmary, University Hospital of North Durham and Royal Blackburn Hospital.

The study, registered under the ISRCTN registry identifier ISRCTN12414986, is expected to yield valuable insights into the accuracy and reliability of the new fingerprick blood test for LVO stroke identification. Upfront Diagnostics is committed to advancing medical science and improving patient care through rigorous clinical research.

Gonzalo Ladreda, Co-Founder and CEO of Upfront Diagnostics, commented on the potential impact of this research: “We are excited to pioneer a change in stroke management worldwide. After many years of developing and testing this revolutionary technology, we are entering the latest phase of trials before commercialisation. We remain committed to our mission of increasing access to thrombectomy. We anticipate impacting millions of lives in the coming years”.

Christopher Price, Professor of Stroke Research, Newcastle University and NHS Consultant, Northumbria Healthcare NHS Foundation Trust, comments: “Each year in the UK, there are approximately 15,000 stroke patients with LVO who are suitable for thrombectomy treatment. The RADAR study will provide essential information about how accurately and quickly the LVOne test can identify these patients amongst a much bigger hospital population of patients with similar symptoms.”

Price continues: “If our clinical research across the North of England shows that the LVOne test can accurately identify those patients who should go directly to a specialist hospital for emergency thrombectomy, then it will reduce delays in treatment and improve recovery from the devastating effects of severe stroke”.

University of Cambridge students Gonzalo Ladreda, Dr Edoardo Gaude, Marcos Ladreda, and Dr Joshua Bernstock founded Upfront Diagnostics (previously known as Pockit) in 2017 and Apex Venture as well as Cambridge Enterprise have backed it ever since. A team including biologists, clinicians and an experienced senior group with a long history in diagnostics and life sciences.