Sarissa Biomedical Ltd and SMARTChip

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Case Study Summary
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Overview summary:
SMARTChip is a purine biosensor which uses a finger-prick sample of blood to detect ischaemic brain events that occur during a stroke. It’s been developed to address the need for a rapid diagnostic test to help decision making in early stages of a stroke.

SMARTChip was created by Prof Nick Dale of the University of Warwick and developed in a NIHR i4i research study carried out at UHCW NHS Foundation Trust under vascular surgeon Prof Chris Imray in collaboration with stroke physician Prof Christine Roffe of UHNM NHS Trust.
Challenge identified and actions taken :
Currently, patients suspected of a stroke are taken to A&E to have a CT scan as confirmation before given thrombolysis treatment; however, the length of time it takes to recognise stroke symptoms is critical as delay in treatment leads to increased damage to the brain. Furthermore, there are no diagnostic tests to help clinicians and paramedics to identify stroke, resulting in high levels of misdiagnosis and delays in treatment.

SMARTChip was created to reduce delays by diagnosing stroke faster and better informing clinical decision making.

Research proved that, at the onset of a stroke, the brain releases a detectable quantity of purines into the blood. Purines are produced and released by cells undergoing the oxidative stress that occurs during a stroke. SMARTChip measures these purines to detect and diagnose symptoms of a stroke faster, improving patient outcomes and saving the NHS time and money.

There were many practical challenges to overcome with the first proof-of-concept device developed (SMARTCap) including difficulty experienced by nurses accurately and rapidly collecting and measuring blood samples in test tubes. This led to modification of the design and the development of SMARTChip. SMARTChip only requires a finger-prick sample of blood thereby simplifying, miniaturising and speeding up the technology.
Impacts / outcomes:

There are several positive outcomes from the SMARTChip project:
  • The study provided an excellent example of partnership working across academia, industry and the NHS.
  • The SMARTChip study has been featured in the national media with articles in The Guardian and the National Institute for Health Research Website.
  • The time it takes for SMARTChip to make a measurement is approximately 3-5 minutes.
  • SMARTChip will be used in conjunction with the existing assessment procedures such as FAST (Face, Arms, Speech, Time) and ROSIER (Rule Out Stroke in the Emergency Room) to aid clinicians to diagnose stroke more rapidly.
  • SMARTChip is also expected to help by triaging patients and directing them to the most appropriate clinical unit.
  • SMARTChip may also be able to detect a number of other injuries including traumatic brain injury (TBI), heart attack and foetal hypoxia.
  • SMARTChip has the potential to improve patient outcomes but also can save major cost to the NHS.
  • SMARTCHIP won the MidTECH Award for Best NHS-Developed Medical Technology Innovation at the WMHASN Awards 2018.
Supporting quote for the innovation from key stakeholders:
Quotes from Nicholas Dale, founder of Sarissa Biomedical Ltd:
“In 10 years’ time, I’d hope that SMARTChip will be in the defibrillator boxes that enable the public to treat cardiac arrest…upgraded with Sarissa’s SMARTChip, they should become multifunctional, enabling the public to contact the health service with more complete information.

“Sarissa has developed a world beating technology that will improve the lives of stroke victims and save the NHS money. Our ambition is to create jobs and economic wealth, we see the development of our production capability as being a key factor in transforming Sarissa from an R&D company into a high value IVD manufacturer and look forward to working with Aston University to deliver our ambition.”

Quote from Norman Phillips, Patient representative:
“Having had a stroke in 2003 at the age of 55 and being treated under the then current practice I was left with hemiplegia on the left side.

“After being discharged I took an interest in stroke treatment and research serving on many bodies and taking part in research in all areas.

“During the time since my stroke I have seen the introduction of the FAST campaign and fast tracking of patients to acute stroke units where diagnosing can be carried out, but, as we know, “time is brains.” The use of thrombolysis is governed by time so speed is of the essence.

“The introduction of SMARTChip will greatly reduce the time element and mean that treatment can begin sooner. Its use would also reduce the number of false diagnoses that turn out not to be a stroke.

“In my mind, and that of other stroke survivors and medical professionals that I have spoken to, this is a major breakthrough in the early diagnosis of the onset of a stroke.”
Which local or national clinical or policy priorities does this innovation address:
National Clinical Priority: One of the key priorities of the Stroke Association and the NHS RightCare Pathway is for stroke to have a more rapid diagnosis and treatment, from a 999 call through to optimal treatment. Every year, around 110,000 people in England have a stroke, and it is the third largest cause of death, after heart disease and cancer. Earlier diagnosis of stroke can better inform clinicians, meaning that treatment can be administered earlier. This leads to fewer complications later, as every minute that a major stroke is untreated, the brain loses some 1.9 million neurons, 14 billion synapses and 7.5 miles of myelinated fibres.
Plans for the future:
Further research studies using SMARTChip in an emergency setting will provide evidence for it to be implemented as an early diagnosis indicator of strokes. A planned study in an ambulance setting will also allow the device to be used and tested on patients with a suspected stroke before they arrive at A&E, again saving critical time in diagnosis and treatment.

Sarissa is now working on developing SMARTChip to support wider diagnosis and treatment of Ischemic Vascular Disease (IVD), with further trials planned for traumatic brain injury, heat attack, foetal hypoxia, limb ischaemia, peripheral artery disease and neurological disorders such as epilepsy.

In the longer term, a ‘wellness’ test is planned to screen people most at risk of a stroke and prevent them occurring.
Tips for adoption:
Final research and testing is reaching its conclusion, with an SBRI funded paramedic led trial of SMARTChip in the North West, North East and West Midlands NHS ambulance trusts and led by Dr Chris Price (Newcastle). SMARTChip is expected to achieve CE marking in 2020 with the product being available commercially by the start of 2021.
Contact for further information:
If you would like more information on the SMARTChip please contact: sales@sarissa-biomedical.com

Further information on Sarissa Biomedical Ltd and SMARTChip is available via the following links:

http://sarissa-diagnostics.com/

http://sarissa-diagnostics.com/?s=Smartchip
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