Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

Genedrive awarded additional grant funding under the DEVOTE programme

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, announces the extension of the highly successful multi-partner grant award from Innovate UK and the UK Government's Innovation Accelerator programme.

The Development and Validation of Technology for Time Critical Genomic Testing ("DEVOTE") grant, saw the Company benefit from approximately £1.2m through a combination of direct grant income, in-kind partner contributions, and other aligned funding. The DEVOTE programme provided the Company with acute care patient access and supporting infrastructure to assess the real-world clinical performance of time-critical clinical tests in NHS settings. The programme's lead partner, the University of Manchester ("UoM"), has supported the evaluation, validation, and implementation of the Genedrive® CYP2C19 ID Kit.

During the DEVOTE programme the Company completed validation and UKCA certification of the Genedrive® CYP2C19-ID Kit, which was subsequently published in the Journal of Molecular Diagnostics in December 2024 and recommended in final guidance from the UK's National Institute for Health and Care Excellence ("NICE") as the rapid genetics platform of choice for use in the NHS for Clopidogrel genotyping after Ischaemic or Transient Ischaemic Attack.

The significant success of the DEVOTE programme has led to follow-on Innovate UK Innovation Accelerator funding to further progress the DEVOTE project, of which the Company will receive £0.2m directly over the next six months for continuation of implementation of user-led product enhancements which are expected to further improve user experiences in rapid genetic testing environments.

Gino Miele, Chief Executive Officer of genedrive plc, said: "The DEVOTE programme has been an incredible success and follow-on funding provides a further opportunity for us to partner once again with the University of Manchester in continuing development of time-critical genetic test solutions. The additional non-dilutive grant funding facilitates the mitigation of development costs that would otherwise have been absorbed by the Company."

For further details please contact:

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.

About DEVOTE

The Development and Validation of Technology for Time Critical Genomic Testing (DEVOTE) Programme is a collaboration between academics, clinicians, and industry partners. It aims to accelerate the adoption of genomic technology into clinical practice by supporting companies through each aspect of the translational pathway.

Programme information is available at:

https://gmbusinessboard.com/news/innovation-accelerator-programme-extended-to-boost-growth-across-the-uk