dramatically improve outcomes for thousands of people in the UK affected by stroke each year.
Developed by researchers from Manchester University NHS Foundation Trust (MFT) and The University of Manchester, in collaboration with Manchester based company genedrive, the test can tell healthcare professionals in approximately one hour if stroke patients will be more likely to benefit from clopidogrel, the current first-line treatment to prevent recurrence.
Approximately 100,000 people in the UK each year will have a stroke - a serious life-threatening condition that happens when the blood supply to part of the brain is cut off by a blood clot.
Clopidogrel prevents platelets (a type of blood cell) from sticking together and forming a dangerous blood clot. However, around 29 per cent of all patients in the UK (and up to 60 per cent in different ethnic groups) have a change in the CYP2C19 gene which reduces clopidogrel's effectiveness.
Individuals carrying changes in the CYP2C19 gene are also twice as likely to have further strokes when treated with clopidogrel. If these genetic changes can be detected before treatment, then doctors can use an alternative, more effective medicine.
Professor Bill Newman, Consultant in Genomic Medicine at MFT and Professor of Translational Genomic Medicine at The University of Manchester who led the project said: "Strokes affect more than 6,000 people in Greater Manchester each year and those affected are at increased risk of further severe strokes in the following hours, days and weeks.
"This is clearly a particularly worrying time for patients and their families; therefore, it is vital we use new approaches to ensure that patients get onto the right treatment as quickly as possible."
Professor Newman, who is also Rare Conditions Co-Theme Lead at the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC), added: "This could reduce time spent in hospital, prevent further strokes, save lives, and avoid future hospital admissions.
"If adopted into routine practice, this rapid test, which has been recommended for use in the NHS by the National Institute for Health and Care Excellence (NICE), represents a major transformation in the way we manage stroke in this country.
"Our early model-based cost-effectiveness analysis published last year shows that using a rapid genetic test could lead to significant cost savings for the NHS. Using a rapid genetic test was £512 less expensive compared with no testing per patient, due to the prevention of secondary strokes and reduced hospital admissions. When you factor in the potential improvements in patient's quality of life, the model estimates that the potential value of the test to the NHS is over £160 million each year."
Using a simple cheek swab, the non-invasive test can be performed at the bedside. From the swab, the genedrive system interprets the genetic information on the patient and informs the clinician with options on the course of treatment.
Previously, genetic testing for CYP2C19 could only be carried out using specialist laboratories, a process which can take several days.
The innovative test was used successfully at Manchester Royal Infirmary and the Manchester Centre for Genomic Medicine, Saint Mary's Hospital, both part of MFT, over six months, to evaluate performance in the clinical setting.
Further testing will be carried out at Greater Manchester's Hyper Acute Stroke Unit (HASU) at Salford Royal Hospital, part of Northern Care Alliance NHS Foundation Trust, to establish the benefit for patients across Greater Manchester. HASU is the largest dedicated unit in the region and provides care for people across Greater Manchester. This work is part supported by the Geoffrey Jefferson Brain Research Centre through the Edward and Victoria Bonham Carter fund and NHS England Network of Excellence in Pharmacogenetics and Medicines Optimisation.
This pilot is an important step in understanding the set-up costs, workforce and other requirements to roll out this innovation wider.
Dr John McDermott, Clinical Geneticist at MFT and NIHR Fellow from The University of Manchester said: "Genomic medicine is changing the future of healthcare and we are delighted NICE has recommended the use of the test in the NHS.
"As part of the NHS Genomic Networks of Excellence work that we are leading, we are now working with colleagues across the country to work out the best ways to introduce genetic testing for CYP2C19 for patients who have just experienced a mini-stroke (TIA) or acute stroke."
This research is part of the DEVOTE programme, an Innovate UK funded project coordinated by Health Innovation Manchester, led by The University of Manchester and supported by MFT.
The programme builds on research supported by the NIHR Manchester BRC, hosted by MFT, which focuses on making pharmacogenetic testing more accessible to patients to improve clinical outcomes.
Dr Gino Miele, Chief Scientific Officer, genedrive plc, said: "The collaboration of our company with the research and clinical team at MFT is a shining example of the NHS collaborating with a commercial company, from early product development through to clinical validation in real-world settings, to deliver real improvements in patient outcomes in a cost-effective way. We are delighted with the positive recommendation from NICE and the success of the multi-disciplinary team collaboration under DEVOTE. We look forward to our CYP2C19 ID kit, the second point of care pharmacogenetic test developed in collaboration with this team for NHS use, being made available for the benefit of patients who have suffered a stroke or TIA."
Professor Ben Bridgewater, Chief Executive at Health Innovation Manchester, said: "The recommendation by NICE for the point-of-care test is a demonstration of how the DEVOTE programme is supporting the development, validation and implementation of innovative genomic tests in healthcare. The planned implementation testing at Northern Care Alliance NHS Foundation Trust is an important milestone for validating the use in a real-world setting of a personalised approach to provide healthcare to patients that have suffered a stroke. Providing better care for cardiovascular diseases is a high priority for Health Innovation Manchester and we are committed to continue our support to the DEVOTE programme."
Juliet Bouverie OBE, Chief Executive of the Stroke Association said: "Stroke devastates lives and leaves people with life-long disability. We know that many stroke survivors spend the rest of their lives fearing another stroke, so it's great to see that more people could be given appropriate help to significantly cut their risk of recurrent stroke. Anything we can do to prevent the misery that stroke can cause is ultimately good news. Getting on the right medication and taking it as advised is the best way for stroke survivors to reduce their risk of further strokes.
"If you are a stroke survivor and have questions about the medication that you have been prescribed, you should keep taking your medication and contact your GP surgery."
