Genedrive (AIM:GDR), the AIM-listed point-of-care pharmacogenetic testing company, has signed a product development collaboration agreement with Thermo Fisher Scientific to develop a high-throughput CYP2C19 in vitro diagnostic test for centralised laboratory settings.
The new Genedrive CYP2C19 HT Kit is designed to run on Thermo Fisher's QuantStudio 5 Dx real-time PCR platform and targets a different market segment from genedrive's existing rapid CYP2C19 ID Kit, which is built for near-patient use. Together, the two products are intended to cover both decentralised and laboratory-based CYP2C19 testing pathways. The HT Kit operates directly from blood without nucleic acid extraction, reducing workflow complexity and consumable use in high-volume laboratory environments, and targets the same six-allele panel as the point-of-care product to maximise ethnic inclusivity.
UKCA certification for the HT Kit is on track for around the end of 2026, with the UK NHS genomic laboratory market as the initial target. CYP2C19 testing is recommended by NICE to guide antiplatelet therapy following ischaemic stroke or transient ischaemic attack, a population of approximately 100,000 new stroke patients annually in the UK.
"This collaboration expands our CYP2C19 offering into the high-throughput laboratory diagnostics market," said CEO Gino Miele, adding that access to Thermo Fisher's global installed base of PCR platforms would accelerate entry into a significant new market segment.
