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Genetic test could become new standard of care for stroke

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A new emergency care test that screens stroke patients for a potentially problematic genetic variant could be available by August next year.

Molecular diagnostic company Genedrive has developed the rapid point-of-care test, which is already being used to screen newborns for the genetic variant, m.1555A>G.

If the National Institute for Health and Care Excellence (NICE) deems the test to be effective for stoke, it could become the new standard of care for stroke patients.

The health evaluator is compiling guidance on the benefits of genetic screening prior to administration of clopidogrel.

The drug is commonly given after an ischaemic stroke or transient ischemic attack (TIA) to reduce the likelihood of further blood clot formation.

However, people who have certain genes such as the CYP2C19 gene will not respond to the antiplatelet therapy.

Genedrive’s CYP2C19 genotyping test provides results in a clinically actionable timeframe – often within an hour – with healthcare cost savings including a reduction in hospital stays.

David Budd, CEO of Genedrive PLC, said:

“Effective genotyping could create important progress for stroke treatment.

“Currently, genetic testing is not part of the standard stroke care pathway and no rapid testing for CYP2C19 is carried out before clopidogrel use after ischaemic stroke or transient ischaemic attack.”

Clopidogrel is less effective in people with a certain variant of the CYP2C19 gene because they do not metabolise clopidogrel fully.

Consequently, the drug has a reduced impact on lowering the risk of a further stroke.

Strokes occur more frequently in people from Black African, Black Caribbean or South Asian family backgrounds.

Improving antiplatelet therapy would be particularly beneficial in these groups as CYP2C19 is about 50 times as prevalent among individuals from an East Asian family background compared with a those from a European family background.

Budd added:

“Point-of-care tests fit well with recommendations for genotyping patients prior to administering clopidogrel.

“Genetics laboratories remain distant from patients and may have up to two-week turnaround times, whereas therapies should be prescribed within 24 hours.

“Genedrive’s CYP2C19 kit in contrast will deliver a result in less than an hour. If you want to have a genetic result within a day, you need a device near a patient.

“It could be that as rapid genotyping comes into the emergency care setting, its use will become broad and applicable to a wide range of better patient outcomes.”

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