Genedrive Regulatory News (GDR)

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED IN ARTICLE 7 OF REGULATION (EU) NO 596/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 16 APRIL 2014 ON MARKET ABUSE (MARKET ABUSE REGULATION) AS RETAINED AS PART OF UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 AS AMENDED.

genedrive plc

("genedrive" or the "Company")

Directorate change

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, announces that its Chief Executive Officer ("CEO"), James Cheek, has left the Company with immediate effect by mutual agreement.

James has been succeeded as CEO by Dr. Gino Miele PhD, currently Chief Scientific Officer ("CSO") who has been with the Company since 2011, serving as R&D Director and since September 2023 as CSO and an Executive Board Director. Prior to joining the Company Gino served as an Associate Director for clinical translational genomics at Wyeth and Pfizer.

Gino has been a key driver in the development of the genedrive instrumentation and products, positioning the Company at the forefront of pharmacogenomic testing in emergency healthcare settings and with the wider team has facilitated regulatory approval processes for the products throughout the UK, Europe and the Middle East. Gino was instrumental in the NICE approval processes for both the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit, securing the Group's clinical trial agreement in the U.S., the recent FDA breakthrough device designation, and together with the genedrive commercial team is actively involved in generating a growing list of revenue opportunities in the UK and more widely. 

Dr. Ian Gilham, Chairman of genedrive plc, said: "Gino has an unparallelled knowledge and understanding of the Company, products and commercial strategies. I have every confidence that the leadership team, headed by Gino and strongly supported by our Chief Financial Officer, Russ Shaw, will lead genedrive to a successful future. I would like to thank James for his contributions at genedrive and, on behalf of the board, wish him well for the future."

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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.