Genedrive hopeful of product adoption and regulatory clearances
Genedrive PLC on Monday said it is ‘well positioned’ to build on the progress achieved during 2025.
The Manchester, England-based point-of-care pharmacogenetic testing company said its pretax loss widened to £2.6 million in the six months to December from £2.5 million the year prior.
Revenue and other income increased to £570,000 from £350,000, but diagnostics costs grew to £2.3 million from £2.1 million.
Basic and diluted losses per share were 0.3 pence compared to 0.4p a year ago.
Cash was £400,000 at December 31, down from £1.2 million as at June 30.
Chief Executive Gino Miele said the company is ‘well positioned’ to build on the progress achieved during the period.
Miele said the firm remains focused on executing the commercialisation of Genedrive CYP2C19 and MT-RNR1 across the UK, Europe, and Middle East, advancing regulatory milestones including the US Food & Drug Administration pathways, and continuing to generate ‘real-world evidence’ to support broader commercial adoption in the UK.
The Genedrive MT-RNR1 ID kit currently in use across 14 hospitals in the UK, while the CYP2C19 ID kit is currently in use at Salford Hyper Acute Stroke Unit, the largest in England, initially as part of a national pilot programme.
In the US, Genedrive has received FDA breakthrough device designation for its MT-RNR1 ID kit and is pursuing a de novo pathway for US market approval.
Genedrive said it will continue to engage with National Health Service stakeholders, Integrated Care Boards, senior NHS and government stakeholders and international partners to drive adoption and implementation of its technologies.
‘Whilst market conditions and local NHS funding constraints have been challenging, the board anticipates an improvement in the new NHS financial year (commencing in April) in a phased process that could take up to 12 months,’ the firm added.
Shares in Genedrive were up 1.5% at 0.99 pence each in London on Monday.
Copyright 2026 Alliance News Ltd. All Rights Reserved.