Genedrive PLC on Wednesday said that its CYP2C19 point of care test achieved marking registration in the UK, known as UKCA.

Genedrive shares rose 17% to 13.20 pence each on Wednesday morning in London.

The molecular diagnostics company said the test to help manage treatment in stroke patients is now readying for NHS introduction, targeting December.

Furthermore, Genedrive expects to submit its application for the EU’s CE marking in the first half of 2024.

‘UKCA marking now allows the company to begin commercialisation in the UK, and actively engage in the DEVOTE programme, which will generate additional performance data in an acute care setting. This expanded dataset is required for CE marking submission, which will allow for commercialisation in the EU,’ Genedrive explained.

In May, the company announced that the UK’s National Institute for Health & Care Excellence recommended that CYP2C19 genotyping should be used to manage ischaemic stroke patients.

Chief Executive Officer David Budd said Wednesday: ‘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.’

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