Genedrive wins EU approval for rapid genetic test aimed at stroke and heart attack care
Genedrive PLC (AIM:GDR) has received European regulatory approval for its CYP2C19 ID Kit, a rapid genetic testing device designed to guide treatment decisions in patients who have suffered serious cardiovascular events such as strokes, transient ischaemic attacks, or heart attacks.
The Manchester-based biotech firm said the test is now certified under the EU’s In Vitro Diagnostic Regulation (IVDR) — a major milestone for launching new diagnostic tools across the bloc. The CE-marking also unlocks access to several non-EU markets, potentially widening Genedrive’s global footprint.
The test targets five key genetic variants in the CYP2C19 gene, which influence how patients metabolise Clopidogrel, a commonly prescribed antiplatelet medication. These genetic differences are present in around 30% of the general population — and in some ethnic groups, as many as 56% — and can significantly reduce the drug’s effectiveness, leading to worse clinical outcomes.
Genedrive’s system is specifically designed for use in emergency care, where timely prescribing decisions can be critical. The platform delivers rapid, point-of-care results, helping clinicians select the most effective treatment without waiting for traditional lab testing.
The test has already earned backing from NICE, the UK’s health technology assessment body, which recommended it for use across the NHS. NICE highlighted Genedrive’s superior coverage, faster turnaround times, and stronger economic case compared to lab-based alternatives.
CEO Dr Gino Miele hailed the approval as a pivotal moment for the company:
“These patient outcomes, financial and productivity gains are substantial, and I am excited about the future impact of our solution on patients and healthcare systems both in the UK and internationally.”
