CYP2C19 Agreement with Thermo Fisher Scientific

CYP2C19 Product Development Collaboration agreement with Thermo Fisher Scientific Inc.

genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company, is pleased to announce a collaboration agreement with Thermo Fisher Scientific Inc. enabling genedrive to develop a CYP2C19 pharmacogenetic in vitro diagnostic ("IVD") test for deployment on Thermo Fisher Scientific's QuantStudio™ 5 Dx real-time PCR laboratory platform (the Genedrive® CYP2C19 HT Kit).

The Genedrive® CYP2C19 HT Kit is designed for centralised, high-throughput laboratory testing, addressing a different market segment to the Company's rapid Genedrive® CYP2C19 ID Kit, which targets near-patient settings. Together, the two products position genedrive to serve both decentralised and laboratory-based CYP2C19 pharmacogenetic testing pathways. The Genedrive® CYP2C19 HT Kit is on track for UKCA certification around the end of the 2026 calendar year, initially targeting the UK NHS genomic laboratory market.

The Genedrive® CYP2C19 HT kit targets the same clinically relevant allele panel (*2, *3, *4, *8, *17 and *35) to maximise ethnic inclusivity and is configured as a multiplexed PCR reaction, enabling high sample throughput per run. It is supplied in a lyophilised, ambient temperature-stable format and operates directly from blood without nucleic acid extraction, reducing workflow complexity, hands-on time, and consumable use in high-throughput laboratory environments, maximising sample throughput and minimising hands-on time, processing steps, and consumable use.

There are approximately 100,000 new stroke patients annually in the UK, with approximately 94 million people living with the effects of stroke globally, at a cost of $890 billion per year. In the US each year, there are approximately 690,000 ischaemic strokes, 240,000 TIAs, and 550,000 percutaneous coronary interventions ("PCI") in coronary artery disease.

CYP2C19 pharmacogenetic testing is recommended by the UK National Institute for Health and Care Excellence ("NICE") (https://www.nice.org.uk/guidance/htg724) to guide the use of the antiplatelet drug clopidogrel following ischaemic stroke ("IS") or transient ischaemic attack ("TIA"). NICE recommends laboratory-based CYP2C19 genotype testing and the use of the Genedrive® CYP2C19 ID Kit for rapid point-of-care testing when laboratory-based testing is not available. The American Heart Association supports CYP2C19 genotyping to guide antiplatelet therapies in coronary artery disease, peripheral artery disease, and stroke, and CYP2C19 genotyping.

Dr Gino Miele, CEO of genedrive plc, said: "This collaboration expands our CYP2C19 offering into the high-throughput laboratory diagnostics market, complementing our established point-of-care solution. In addition to access to industry standard chemistries, this collaboration with Thermo Fisher Scientific will enable us to leverage a large global installed base of laboratory diagnostic PCR platforms, accelerating access to a significant new market segment while strengthening our existing pharmacogenetic testing portfolio."

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About genedrive plc (http://www.genedrive.com).

The QuantStudio 5 Dx is For In Vitro Diagnostic Use.

The Genedrive® CYP2C19 HT Kit is For performance evaluation only.