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Genedrive Point-of-Care PGx Test for Stroke Patients Nabs UKCA Mark

NEW YORK – Genedrive announced on Thursday that its point-of-care pharmacogenomic test to determine treatment response in stroke patients has received UK Conformity Assessed marking registration.

The Genedrive CYP2C19 System can be used to determine which stroke patients are likely to respond to clopidogrel treatment by testing for six genetic variants of the CYP2C19 gene that affect the loss of metabolism function and poor activation of clopidogrel, the company said in a statement. The system automatically interprets information for the clinician and returns results in about one hour from a cheek swab sample.

"The use of point-of-care testing allows patients to be put on an optimized treatment plan as quickly as possible," Genedrive CEO David Budd said in a statement. "The risk of recurrent stroke in the week after a [transient ischemic attack] or minor stroke is up to 10 percent, so routine laboratory testing which can take many days or weeks is unlikely to be as appropriate as a point-of-care solution returning results in about one hour."

In performance evaluations, the test was 99 percent accurate in detecting the variants that affect loss of metabolism function, the company said. The UKCA marking will allow the company to begin commercializing the test in the UK and engaging in the DEVOTE program, which will generate further data in an acute care setting, it added. The expanded dataset is required to submit the test for CE marking, which is expected in the first half of 2024.

Draft guidance from the UK's National Institute for Health and Care Excellence released earlier this year recommended that people who have had an ischemic stroke or transient ischemic attack should have a CYP2C19 genetic test before receiving treatment. The final recommendations are expected to be released in December, which Genedrive said it expects to drive momentum for adoption of its test.

"As we begin commercialization and look to registration activities more globally, we will benefit from a rapidly evolving, well-documented clinical understanding and guidance for the use of genetic testing for stroke management," Budd added.

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