UK Manufacturing Capability for Lateral Flow Diagnostic Tests

The UK Health Security Agency (UKHSA) is seeking suppliers to participate in a pre-market engagement exercise to develop and manufacture lateral flow devices (LFDs) in the UK. This pilot activity aims to strengthen the UK's ability to rapidly develop, produce, and deploy diagnostic tests for future health threats, supporting the 100 Days Mission for pandemic response. The programme focuses on building resilient, UK-based manufacturing capability that reduces reliance on international supply chains and improves national biosecurity, while addressing lessons learned from COVID-19 regarding test quality, production scalability, supply chain resilience, and product shelf-life. Suppliers must demonstrate the ability to undertake core stages of assay development, device manufacture, and final assembly within the UK, with a transparent and scalable supply chain that can sustain production during outbreaks. The pilot will involve developing prototype antigen-based LFDs for priority pathogens, evaluating performance against defined specifications, and conducting a comprehensive review of supply chain gaps, manufacturing capacity, and barriers to market entry. This activity serves as a 'stress test' of the UK diagnostics ecosystem and will be completed by 31 March 2027. Following this pilot, UKHSA intends to launch a separate procurement process to establish longer-term sustainable UK manufacturing capability and strategic stockpiling for future pandemics. This is an exploratory engagement to gather market feedback on specifications, procurement approaches, and evaluation methodology; it does not represent a commitment to procure.