Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

Short extension to NICE publication date on CYP2C19 test

genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company, acknowledges, as announced on 3 April 2024, that the UK's National Institute for Health and Care Excellence ("NICE") has recommended in draft guidance that CYP2C19 genotyping should be used to guide clopidogrel use after Ischaemic Stroke ("IS") or Transient Ischaemic Attack ("TIA"), and that the Genedrive® CYP2C19-ID test should be used as the test of choice for point-of-care strategies. 

The final publication was expected by NICE on 10 July 2024, but the Company notes from the NICE website that this has recently been extended to 31 July 2024. Further details can be found at:  https://www.nice.org.uk/guidance/indevelopment/gid-dg10054/documents.

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About genedrive plc (http://www.genedriveplc.com). genedrive plc is a pharmacogenetic testing company developing and commercialising a low cost, rapid, versatile and simple to use point of need pharmacogenetic platform for the diagnosis of genetic variants. This helps clinicians to quickly access key genetic information that will aid them make the right choices over the right medicine or dosage to use for an effective treatment, particularly important in time-critical emergency care healthcare paradigms. Based in the UK, the Company is at the forefront of point-of-care pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on how your individual genetics impact a medicines ability to work for you. Therefore, by using pharmacogenetics, medicine choices can be personalised, made safer and more effective. The Company has launched its two flagship products, the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit, both developed and validated in collaboration with NHS partners and deployed on its point-of-care thermocycler platform. Both tests are single-use disposable cartridges which are ambient temperature stable, circumventing the requirement for cold chain logistics. The Directors believe the Genedrive® MT-RNR1 ID Kit is a worlds-first and allows clinicians to make a decision on antibiotic use in neonatal intensive care units within 26 minutes, ensuring vital care is delivered, avoiding adverse effects potentially otherwise encountered and with no negative impact on the patient care pathway. Its CYP2C19 ID Kit which has no comparably positioned competitor currently allows clinicians to make a decision on the use of Clopidogrel in stroke patients in 70 minutes, ensuring that patients who are unlikely to benefit from or suffer adverse effects from Clopidogrel receive an alternative antiplatelet therapeutic in a timely manner, ultimately improving outcomes. Both tests have undergone review by the National Institute for Health and Care Clinical Excellence ("NICE") and have been recommended for use in the UK NHS. The Company has a clear commercial strategy focused on accelerating growth through maximising in-market sales, geographic and portfolio expansion and strategic M&A, and operates out of its facilities in Manchester.

The Company has a clear commercial strategy focused on accelerating growth through maximising in-market sales, geographic and portfolio expansion and strategic M&A, and operates out of its facilities in Manchester.