Image source: © 2025 Krish Capital Pty. Ltd.

Highlights:

  • GDR expects FY25 income to double to around GBP 1 million.
  • The company has secured early FY26 revenue visibility of approximately GBP 0.6 million.
  • GDR progressing with U.S. FDA regulatory submissions for key products.

Genedrive plc (AIM:GDR), a UK-based point-of-care pharmacogenetic testing company, has issued its unaudited trading update for the financial year ended 30 June 2025 (FY25), reporting an anticipated doubling of total income to approximately GBP 1 million compared to GBP 0.5 million in FY24 and GBP 0.06 million in FY23. The increase in annual income was largely driven by sales momentum in the second half of FY25, which generated GBP 0.65 million, compared to GBP 0.35 million in the first half. Overheads for FY25 were maintained at similar levels to the prior year, reflecting a strategic shift towards targeted commercial activities.

For the current financial year (FY26), the company has reported early visibility of around GBP 0.6 million in income within the first two months, supported by several developments:

  • Completion and submission of the National Institute for Health and Care Excellence (NICE) Early Value Assessment (EVA) evidence generation, intended to facilitate broader UK adoption of its products.
  • The phased national rollout in Scotland of the Genedrive® MT-RNR1 ID Kit, alongside a CYP2C19 point-of-care pilot programme comparing its system against laboratory testing pathways, both scheduled to begin in or around October 2025.
  • The commencement of a 12-month Acute Coronary Syndrome and CYP2C19 rapid genotyping programme at Manchester University NHS Foundation Trust.

Internationally, Genedrive anticipates further revenue growth as commercial activities expand in Europe and the Middle East. Early product sales have already been recorded in target markets including Italy, the Netherlands, UAE, Bahrain, Kuwait, Saudi Arabia, and Qatar. In the U.S., the company is progressing regulatory pathways for its two main products. The Genedrive® MT-RNR1 ID Kit is under the FDA Breakthrough Device programme, while a 510(k) submission for the Genedrive® CYP2C19 ID Kit is planned for early 2026, followed by an expected 3–4 month review period.

As of the latest update, cash balances stand at approximately GBP 700,000. The board and its advisers are evaluating a range of financing options to boost working capital and support ongoing operations.

The company notes that the UK healthcare policy environment is undergoing significant change. The Government’s 10-Year Health Plan for England aims to expand NICE’s technology appraisal process to include medical devices, diagnostics, and digital products, with mandated NHS funding for high-impact innovations. These reforms are expected to be in place by April 2026 and could influence the adoption of Genedrive’s diagnostic tools across NHS organisations.

Looking ahead, the company intends to balance its domestic growth opportunities with international expansion, while continuing to pursue regulatory approvals and commercial partnerships in priority markets.

GDR is trading 11.11% lower at GBX 1.00 per share as of 11 August 2025.