genedrive plc (AIM: GDR) has entered into a product development collaboration with Thermo Fisher Scientific to develop a high-throughput CYP2C19 pharmacogenetic test for deployment on Thermo Fisher’s QuantStudio™ 5 Dx real-time PCR platform.
The collaboration will enable genedrive to broaden its pharmacogenetic testing portfolio beyond point-of-care settings by introducing the Genedrive® CYP2C19 HT Kit, a laboratory-based in vitro diagnostic designed for high-volume testing.
The new assay complements the company’s existing Genedrive® CYP2C19 ID Kit, which provides rapid bedside testing, allowing genedrive to address both decentralised and central laboratory markets. The company is targeting UKCA certification by the end of 2026, with an initial focus on NHS genomic laboratories.
The Genedrive® CYP2C19 HT Kit detects six clinically important CYP2C19 variants (*2, *3, *4, *8, *17 and *35), providing broad ethnic coverage while using a multiplex PCR format to maximise laboratory throughput. The assay is supplied in a lyophilised, room temperature-stable format and can operate directly from whole blood without requiring nucleic acid extraction, reducing processing time, consumable costs and laboratory workflow complexity.
The collaboration gives genedrive access to Thermo Fisher’s widely installed QuantStudio diagnostic platform, significantly expanding the commercial opportunity for its pharmacogenetic testing technology.
CYP2C19 testing is increasingly being adopted to personalise treatment with the antiplatelet drug clopidogrel following ischaemic stroke and transient ischaemic attack. In the UK, the National Institute for Health and Care Excellence (NICE) recommends CYP2C19 genotype testing to guide treatment decisions, with laboratory testing supported alongside rapid point-of-care testing where appropriate.
The commercial opportunity is substantial, with around 100,000 new stroke patients each year in the UK, while globally an estimated 94 million people live with the effects of stroke. In the United States, approximately 690,000 ischaemic strokes, 240,000 transient ischaemic attacks, and 550,000 coronary interventions are performed annually, all representing potential markets for pharmacogenetic testing.
Chief executive Dr Gino Miele said the agreement extends genedrive’s reach into the high-throughput diagnostics market while complementing its established point-of-care offering. He added that access to Thermo Fisher’s installed base of laboratory PCR platforms should accelerate market adoption and strengthen the company’s growing pharmacogenetics portfolio.
