Lateral Flow Device Pilot and Development Activity

Description

The UK Health Security Agency (UKHSA) is inviting suppliers to participate in this pre-market engagement exercise for the Lateral Flow Device (LFD) pilot and development activity. This work supports UKHSA’s broader strategy to strengthen the UK’s ability to understand, prevent, and respond to health threats, as set out in the UKHSA Strategy 2026–2029. It also aligns with the UK’s commitment to the 100 Days Mission, which aims to enable the rapid development and deployment of diagnostics, therapeutics, and vaccines within 100 days of identifying a new pandemic threat. A key objective of this programme is to develop resilient, scalable UK-based manufacturing capability for LFDs, reducing reliance on international supply chains and improving national biosecurity. For the purposes of this exercise, UK-based manufacturing refers to the ability to undertake core stages of assay development, device manufacture, and final assembly within the UK, supported by a robust and scalable supply chain. Suppliers are not required to have a fully domestic supply chain but must demonstrate transparency, resilience, and the ability to sustain production at scale during an outbreak. LFDs, particularly antigen-based LFDs, were a key component of large-scale population testing during the COVID-19 response and are expected to play a similarly critical role in future pandemic testing strategies. However, lessons learned from COVID-19 highlighted challenges relating to test quality and performance, the ability to scale production rapidly to meet demand, supply chain resilience, and product shelf-life. This programme seeks to address these challenges by assessing the UK’s capability to develop, manufacture, and supply LFDs at pace and scale, ensuring a resilient and sustainable diagnostic testing capability for future outbreaks. The pilot activity will focus on testing the feasibility of onshore development of antigen LFDs. This will involve working with UK-based manufacturers to develop prototype diagnostics for priority pathogens and evaluating their performance against defined target product profiles within required timelines. The pilot will act as a “stress test” of the UK diagnostics ecosystem, covering the full development lifecycle, alongside an assessment of the risks and barriers to bringing products to market through a desktop review of supply chains and production capacity. The pilot will generate insights to identify supply chain gaps, validate capability, and refine processes for rapid deployment during public health emergencies. It is expected to be delivered by 31 March 2027. In parallel, UKHSA intends to explore options for longer-term provision beyond FY 26/27 through a separate procurement process, which will be developed alongside this pilot. UKHSA is currently considering the use of a Competitive Flexible Procedure under the Procurement Act 2023; however, this may be subject to change following further information gathered as the pilot progresses. The requirement beyond this initial pilot activity will focus on establishing sustainable UK manufacturing capability, scalability, and resilient supply chains, to support UKHSA’s strategic stockpiling and response to future pandemics. This engagement aims to share UKHSA’s current thinking and gather feedback from the market regarding the proposed specification, procurement approach, contract, and tender evaluation methodology to inform final approvals for the procurement strategy. This engagement is exploratory and does not represent a commitment to procure at this stage.

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