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Genedrive’s CYP2C19-ID Test Receives NICE Recommendation for Stroke Management

NextEdge Admin

04 Apr 2024

3 min 12 sec

Genedrive announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended the Genedrive® CYP2C19-ID test as the preferred point-of-care (POC) test before administering clopidogrel to patients with Ischemic Stroke (IS) or Transient Ischaemic Attack (TIA). Clopidogrel, an antiplatelet drug, is metabolized by the CYP2C19 enzyme encoded by the CYP2C19 gene. However, variations in this gene can reduce the enzyme’s function, leading to suboptimal responses to clopidogrel in some individuals.

The Genedrive® CYP2C19-ID test requires a simple cheek swab sample and rapidly identifies six key genetic variants of the CYP2C19 gene, facilitating prompt administration of optimized treatment plans. With over 77 million global IS cases and an estimated 100,000 strokes in the UK annually, suboptimal responses to antiplatelet treatment are common, particularly among certain ethnic groups.

NICE’s draft guidance, subject to public consultation until April 26, 2024, emphasizes the importance of genetic testing before antiplatelet treatment, considering both clinical and economic impacts. The committee concluded that individuals with loss-of-function CYP2C19 alleles benefit from alternative antiplatelet therapies, and genetic testing is cost-effective compared to not testing.

The recommendation of Genedrive® as the POC platform of choice for CYP2C19 genotyping in the NHS reflects its superior features, including broader coverage of genetic variants, eliminating the need for cold-chain storage, and seamless integration with electronic healthcare systems.

Genedrive’s partnership with clinical genetics collaborators in Manchester, through the DEVOTE program, strengthens its clinical performance data and supports UKCA certification and anticipated CE-IVD certification by early 2025. Pending the final NICE recommendation in July 2024, the company aims to pursue commercialization in the UK.

James Cheek, CEO of Genedrive plc, expressed delight at NICE’s recommendation, emphasizing the test’s role in enhancing stroke management and patient outcomes. Professor Bill Newman from Manchester University NHS Foundation Trust praised the DEVOTE program’s collaboration in developing rapid genomic diagnostics for safer and more effective medicine prescriptions, highlighting the test’s potential in reducing stroke risks for patients.