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
Developed by Manchester based company genedrive, working with a clinical team from
Strokes affect more than 6,000 people in
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% of all patients in the
If these genetic changes can be detected before treatment, then 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.
The technology this week formally receives the
Recent draft guidance from the
Current genetic testing for CYP2C19 can only be carried out using expensive machines in specialist laboratories 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.
The test will be used at
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
'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. 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.'
Dr
'A major challenge faced across healthcare is finding pathways develop, validate, and ultimately implement novel technology like this in the clinical setting.
'In
DEVOTE represents a collaboration between industry, universities, and healthcare professionals to support the development and validation of time critical genomic testing technology, building on
The programme builds on research from the
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