Pharmacogenetic testing company genedrive plc (AIM: GDR) disclosed on Monday that it has entered a collaboration agreement with Thermo Fisher Scientific Inc (NYSE: TMO) to develop the Genedrive CYP2C19 HT Kit, a high-throughput in vitro diagnostic test for deployment on Thermo Fisher Scientific's QuantStudio 5 Dx real-time PCR platform.
The laboratory-based Genedrive CYP2C19 HT Kit complements the company's rapid Genedrive CYP2C19 ID Kit for near-patient testing, enabling genedrive to address both decentralised and centralised pharmacogenetic testing markets. The product is on track to receive UKCA certification by the end of 2026, initially targeting the UK National Health Service genomic laboratory market.
This multiplex PCR test detects six clinically relevant CYP2C19 alleles and is designed for high-throughput workflows. It operates directly from blood without nucleic acid extraction and is supplied in a lyophilised, ambient temperature-stable format to simplify laboratory processing and improve efficiency.
CYP2C19 pharmacogenetic testing is recommended by the National Institute for Health and Care Excellence to guide clopidogrel treatment following ischaemic stroke or transient ischaemic attack. NICE recommends laboratory-based testing and the Genedrive CYP2C19 ID Kit for rapid point-of-care use when laboratory testing is unavailable.
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