The Genedrive PLC (LON: GDR) share price surged 29.3% after announcing that its latest CYP2C19 test for stroke patients had been awarded the UKCA marking registration. The point-of-care test can differentiate between patients that can respond to clopidogrel treatment and those that cannot. test
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The company noted that the test can help physicians prescribe the right treatment for stroke patients immediately after a stroke, given that it can be performed in a ward or at the bedside and can provide a clinically actionable result in about one hour.
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The test addresses the poor response to treatment from stroke patients following a stroke. About 30% of patients are affected in the general population and up to 50% in certain ethnic groups, according to recent data.
The Genedrive® CYP2C19 test uses a single, non-invasive cheek swab sample. It then rapidly identifies six crucial genetic variants of the CYP2C19 gene, which play a critical role in the loss of metabolism function and poor activation of clopidogrel in a patient.
The test saves physicians time by automatically interpreting the results, allowing them to immediately move on to drug prescriptions once the test results are available. The test also does not require a laboratory setting, making it useful outside a hospital.
The tests are packaged in a temperature-stable, freeze-dried format, like all Genedrive products, to allow healthcare workers to perform the test away from laboratory locations. The test achieved 99% accuracy in detecting the variants that underpin the loss of metabolic function in its performance evaluations.
The UKCA marking allows the company to start commercialisation in the UK and actively engage in the DEVOTE programme unveiled in May 2023.
David Budd, Genedrive plc’s CEO, said: “UKCA marking of the Genedrive® CYP2C19 test is a milestone for the Company as we formally register our second pharmacogenomic test for use in emergency medicine. As we begin commercialisation 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. The use of point of care testing allows patients to be put on an optimised treatment plan as quickly as possible.”
Genedrive share price.
The Genedrive share price surged 29.33% to trade at 14.55p, from Tuesday’s closing price of 11.25p.
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