genedrive has achieved a key regulatory milestone that will enable its new pharmacogenomic test to be introduced in the NHS to help manage treatment for stroke patients.
The UK-based point of care molecular diagnostics company announced has secured UKCA marking registration for its Genedrive CYP2C19 System, a rapid genetic test that can identify how patients will respond to the common anti-platelet drug clopidogrel that is used to help prevent secondary strokes.
genedrive shares were 17% higher on Wednesday after announcing the UKCA marking registration.
The new point of care test only requires a simple cheek swab and can provide clinicians with clinically actionable results in about one hour, allowing more effective and personalized prescription of treatment for individual stroke patients.
Poor response to clopidogrel affects up to 30% of stroke patients in the general population and up to 50% in certain ethnic groups, leading to worse health outcomes. The new rapid genetic test aims to address this issue.
In draft guidance issued in May, the UK’s National Institute for Health and Care Excellence (NICE) recommended that stroke patients should undergo CYP2C19 genetic testing before treatment. This has paved the way for adoption of genedrive’s pharmacogenomic test in the NHS.
Achieving UKCA marking now allows genedrive to start commercialising the test in the UK. The company will initially sell the test through its direct sales team.
The key next steps are to complete a UK clinical evaluation programme and secure CE marking in 2024 to enable wider commercialization in the EU.