The UK's National Institute for Health and Care Excellence (NICE) has issued final guidance recommending the use of Genedrive's CYP2C19 genotyping test to guide clopidogrel treatment in patients who have suffered an Ischaemic Stroke (IS) or Transient Ischaemic Attack (TIA).
NICE specifically recommends the Genedrive® CYP2C19-ID test as the preferred point-of-care testing solution for this patient group. The test, which utilises a non-invasive cheek swab, quickly identifies six genetic variants of the CYP2C19 gene. This information empowers clinicians to optimise treatment plans for stroke patients by tailoring their care based on their individual genetic makeup.
The NICE committee's decision was based on a thorough systematic review of the clinical and economic impacts of CYP2C19 genetic testing. Their findings concluded that testing is not only beneficial for patients with specific genetic variants but also cost-effective compared to not testing.
This recommendation, alongside the existing UKCA certification, paves the way for Genedrive plc to commercialise its product in the UK and select Middle Eastern countries.
"We are delighted with this final guidance from NICE recommending implementation of CYP2C19 genotype-guided use of Clopidogrel in IS and TIA patients in the NHS to reduce the risk of recurrent strokes, and recommendation of our CYP2C19 ID-kit as the point-of-care interventional platform of choice," said James Cheek, CEO of Genedrive plc.
"This represents a key milestone in our commercialisation plans for the product, and further solidifies our business strategy of leading provision of cost-effective solutions for pharmacogenetics in time-critical emergency healthcare situations. We are proud to be at the forefront of the emergence of near-patient genetic testing in emergency healthcare to facilitate optimal personalised therapeutic choices and ultimately improve patient outcomes."
The NICE recommendation for Genedrive's CYP2C19 test signifies a significant step forward in the field of personalised medicine. This advancement has the potential to revolutionise stroke treatment, empowering healthcare professionals to deliver tailored care based on each patient's individual genetic profile. This could lead to a reduction in the risk of recurrent strokes and improved long-term outcomes for patients.
