GENinCode Secures Funding to Accelerate Commercial Push

GENinCode raises £4.7M to fund US marketing and EU/UK expansion, following key NY state approval for its CARDIO test and NHS adoption of its ovarian cancer test.

GENinCode has bolstered its balance sheet with a capital raise, securing gross proceeds of approximately £4.7 million. The funds are earmarked to accelerate the expansion of its genetic diagnostics business, shifting focus toward large-scale commercialization following key regulatory approvals.

Strategic Financing for Market Growth

The capital increase, finalized in early February, involved the issuance of more than 466 million new ordinary shares. Management has indicated the primary use of proceeds will be to fund marketing initiatives in the United States and to support the expansion of commercial operations within the European Union and the United Kingdom. Notably, participation in the placement by members of the company's own board of directors is viewed as a strong signal of internal confidence in the strategic roadmap.

Regulatory and Commercial Milestones

A major operational focus remains the U.S. market. A significant step was taken in December when the company's CARDIO inCode-Score® test received approval in the state of New York. This clearance paves the way for reimbursement through the state's Centers for Medicare and Medicaid Services (CMS). Looking ahead, GENinCode is preparing to submit additional data to the U.S. Food and Drug Administration (FDA) in the first quarter of 2026, with the goal of obtaining a national De Novo authorization.

Concurrently, the company is making headway in oncology within the UK's National Health Service. Since September, the University College London Hospitals NHS Trust has been offering the ROCA® test for ovarian cancer monitoring. This adoption follows a recommendation from the UK's National Institute for Health and Care Excellence (NICE), which classified the procedure as the preferred method for high-risk patients.

With its liquidity now reinforced, the company is positioned to execute its next phase of growth. Immediate priorities include the delivery of data to the FDA, announced for March, and the planned rollout of the ROCA® test to additional NHS hospital groups across the UK.