genedrive PLC (AIM:GDR) has received European regulatory approval for its rapid genetic testing kit used to help guide treatment decisions in patients who have suffered serious cardiovascular events, such as strokes or heart attacks.
The Manchester-based company said its CYP2C19 ID Kit has been certified under the European Union’s latest In Vitro Diagnostic Regulation (IVDR), a requirement for bringing new diagnostic devices to market across the bloc.
The approval is also recognised in several countries outside the EU, potentially expanding the company’s international reach.
The technology identifies five genetic variants in the CYP2C19 gene, which affect how well patients respond to Clopidogrel, a widely prescribed antiplatelet drug.
These genetic differences are present in around 30 per cent of the general population, and up to 56 per cent in certain ethnic groups.
In patients with these variants, Clopidogrel is less effective, often leading to poorer outcomes after events such as ischaemic strokes, transient ischaemic attacks or acute coronary syndrome.
Genedrive’s test is designed for use in emergency care settings, where rapid prescribing decisions can be critical. The company said its platform can identify genetic variants quickly, helping clinicians choose the most effective treatment at the point of care.
The kit has already been backed by the National Institute for Health and Care Excellence (NICE), which recommended it for use in the National Health Service.
NICE found that Genedrive’s system offered better coverage and faster results than traditional laboratory-based tests, along with stronger economic justification.
The company described the CE-marking as a key step in making the test available more widely.
"These patient outcomes, financial and productivity gains are substantial and I am excited about the future impact of our solution to patients and healthcare systems both in the UK and internationally," said CEO, Dr Gino Miel.