A ward-based genetic test developed by Manchester-based diagnostics company Genedrive, in collaboration with clinical and academic teams from The University of Manchester and Manchester University NHS Foundation Trust, has been awarded the UK Conformity Assessed (UKCA) product mark. The certification, which is the UK equivalent of the European CE mark, clears the path for wider evaluation and adoption of the test within the National Health Service.
The test is designed to determine whether stroke patients carry genetic variations in the CYP2C19 gene that affect their ability to metabolise clopidogrel, the standard first-line treatment prescribed to prevent secondary strokes. Approximately one in four to one in three patients carry such variations, and in some ethnic groups the proportion can be significantly higher. Patients with these genetic profiles face an increased risk of recurrent stroke when treated with clopidogrel alone.
From Laboratory to Bedside
Until recently, genetic testing for CYP2C19 variants could only be performed using specialised laboratory equipment, with results typically taking days or even weeks to return. This delay makes laboratory-based genetic testing impractical for guiding treatment decisions in the acute phase following a stroke, when the risk of recurrence is at its highest.
The newly certified system addresses this problem by miniaturising the gene-reading technology into a portable device roughly the size of a shoebox. Using a simple cheek swab taken at the patient's bedside, the system can deliver a clinically actionable result in approximately one hour. The test requires minimal training to operate and does not depend on laboratory infrastructure, making it suitable for deployment in stroke units and other acute care settings.
Clinical Significance and the Case for Rapid Testing
The clinical case for rapid CYP2C19 testing is supported by growing international consensus. Guidance from multiple professional bodies has recommended that patients presenting with ischaemic stroke or transient ischaemic attack should be offered genetic testing to guide antiplatelet therapy selection. The rationale is straightforward: by identifying patients who are unlikely to respond to clopidogrel within minutes of presentation, clinicians can prescribe alternative treatments without delay.
Health economic modelling suggests that widespread adoption of bedside CYP2C19 testing could prevent thousands of additional strokes annually across the United Kingdom, with corresponding reductions in long-term disability, healthcare costs, and the burden on rehabilitation services. The potential savings for the NHS are substantial, given that each prevented stroke eliminates the need for emergency care, hospital admission, and often years of ongoing support.
Next Steps for Clinical Evaluation
With regulatory certification now secured, the test is entering a phase of real-world clinical evaluation across hospital sites in Greater Manchester. This evaluation, conducted under the DEVOTE Programme framework, will assess the technology's performance in routine clinical settings, including its integration into existing stroke care pathways and the practical experience of clinical staff using the device at the bedside.
The achievement of the UKCA mark represents a significant milestone not only for the test itself but for the broader ambition of making pharmacogenetic testing a standard component of acute care in the NHS. As the evidence base continues to grow, attention will turn to scaling the technology beyond Greater Manchester and into stroke units and clinical settings across the country.