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Life-saving bedside stroke test receives UK product safety mark

Following several years of development and validation, product moves closer to NHS adoption



A revolutionary ward-based genetic test which can prevent stroke-related death has received a UKCA product mark, paving the way for its introduction to the NHS.

Developed by Manchester based company Genedrive, working with a clinical team from The University of Manchester and Manchester University NHS Foundation Trust (MFT), the test can quickly tell healthcare professionals if stroke patients will benefit from the current first line treatment, to prevent recurrence.

The Genedrive system this week secured the UK Conformity Assessed (UKCA) mark, the UK’s equivalent of the European CE mark, after a process taking several years of development and validation.

It will be used at Manchester Royal Infirmary and the Manchester Centre for Genomic Medicine, Saint Mary’s Hospital, both part of MFT, over the next six months, to further evaluate performance in the clinical setting.

Strokes affect more than 100,000 people in the UK each year. Individuals carrying changes in a gene called CYP2C19 are twice as likely to have further strokes when treated with the first line preventative treatment, clopidogrel.

Patients being treated for mini strokes, also called transient ischaemic attacks (TIAs), heart attacks, and peripheral vascular disease could also benefit from the technology, the Manchester clinical team says.

The genetic changes – which occur in about 25 per cent of all patients in the UK (and up to 50 per cent in different ethnic groups) – reduce the effectiveness of clopidogrel, which is given as standard for most patients with stroke or TIA in the UK.

If these genetic changes can be detected before treatment, doctors can use an alternative, more effective medicine. This would prevent further strokes, avoiding hospital admissions, saving lives, and reducing costs for the health service.

Recent draft guidance from the National Institute for Health and Care Excellence (NICE) recommended that patients who have had a stroke or TIA should be offered genetic testing for variants in CYP2C19.

Current genetic testing for CYP2C19 can only be carried out using specialist laboratories, in a process which can take several weeks.

However, the Genedrive system uses a miniaturised technology for gene reading which can be performed locally in the ward or bedside, can be used with minimal training, and rapidly provides the clinician results in around an hour.

A cheek swab taken at a patient’s bedside is inserted into a testing cartridge and then the cartridge is inserted into the Genedrive system, which is about the size of a shoebox. 

The instrument interprets the genetic information on the patient and informs the clinician with options on the course of treatment.

Bill Newman, professor of translational genomic medicine at the University of Manchester and consultant in genomic medicine at MFT, leads the project.

He said: “Patients who have had a stroke are likely to be at risk of further, more serious strokes. This is a worrying time for patients, their families and carers. 

“Therefore, it is vital we use new approaches to ensure that patients get onto the right treatment as quickly as possible.”

Joseph, 29, who lives in London, had genetic testing at the Manchester Centre for Genomic Medicine to determine if clopidogrel is the right treatment for him following a stroke.

“After suffering a stroke, I’ve been left with a lot of uncertainty around the cause, as well as apprehension that it could happen again,” he said.

“Confirming my ability to metabolise clopidogrel effectively has given me comfort in my ongoing management and prevention by providing reassurance that the medication is helping limit the risk of a secondary stroke.

“I was grateful that my genetic test results came back within a week but receiving that reassurance within an hour would have undoubtedly improved my experience.

“I feel fortunate to have had the genetic test and I hope that all patients being considered for clopidogrel medication will have the opportunity going forward. Having a bedside test to check the drug is working properly will revolutionise stroke aftercare and patient experience.”