Genedrive PLC shares soared 18% higher after the molecular diagnostics company said it secured UKCA marking for its new Genedrive CYP2C19 System, allowing it to start commercialisaton of the point-of-care test in the UK.
UKCA is the new UK product marking required for certain products placed on the market in Great Britain. It covers most products that previously required the European Union’s CE mark.
Genedrive’s new pharmacogenomic test is recommended for people who have had an ischaemic stroke or transient ischaemic attack (TIA) prior to treatment.
The genetic test can differentiate between patients who could respond to clopidogrel treatment and those who will not, allowing more effective drug treatment, Genedrive said.
It noted that in its performance evaluations, the test achieved 99% accuracy in detecting the variants that underpin loss of metabolism function in stroke patients.
Chief executive David Budd described the UKCA marking as “a milestone” for the company and hailed the speedy results from the test.
“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.
“The risk of recurrent stroke in the week after a TIA or minor stroke is up to 10%, 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."
Genedrive shares surged 17.78% higher to 13.25p.