Lateral Flow Device Pilot and Development Activity

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...