Cost-effective multi-cancer early detection by measuring patient plasma amino acid cross sections with the Enlighten test

Aim To generate evidence on the performance characteristics of Enlighten and to design an NHS programme for use of the test to provide acceptable, effective, equitable and cost-effective screening, to be evaluated in a subsequent Randomised Controlled Trial (RCT). Background SME Proteotype is developing a new type of MCED test called "Enlighten" with a signal that scales with the host protein (immune) response to tumour development, which provides a stronger signal for early-stage tumours. This breakthrough technology has already shown detection of 86% of cancers with 0% false positive rate in a clinical study involving n=132 patients. The portability (distributed diagnostics) and rapid turnaround capability (8 hr) of Enlighten revolutionises how cancer screening can be deployed at scale across UK communities, including those with traditionally low levels of engagement. Enlighten validation in the NHS context is a two-stage process. The first stage is to clinically validate the Proteotype Enlighten MCED assay. The second stage will be to demonstrate how the unique characteristics of the Enlighten MCED assay can disrupt how cancer screening is done at scale, in the community setting with particular emphasis on improving early detection and screening rates in the most deprived populations. The project accomplishes the first stage and plans/illustrates the second stage. Objectives Determine how samples will be processed in an Enlighten distributed diagnostics model Deliver manufactured Enlighten assay kits for the MODERNISED study (not costed) Recruit 1350 participants from a patient population experiencing significant deprivation Calculate sensitivity and specificity of Enlighten for detecting 10 solid tumour cancers with deprivation-associated adverse outcomes Work with the network of place-based partnerships in the lowest deprivation quintile within the recruitment region to develop an understanding of factors limiting uptake of cancer screening within their communities and test non-medical screening methods via a Delphi panel Develop a health economic model to estimate the impact of the Enlighten screening programme compared with current NHS practice on health outcomes and cost-effectiveness, stratified by socioeconomic deprivation Secure Enlighten UKCA/CE marking, FDA Breakthrough Device Status, and NSC interest in In-Service Evaluation Methods The project's pivotal clinical validation study is called MODERNISED. MODERNISED is a pre-specified observational study examining solid tumour cancers where early-stage detection significantly improves outcomes but with notable deprivation gradients. MODERNISED includes 1350 participants, comprising 1000 cancer cases and 350 controls. We have compared and contrasted methodologies, and with our project statistician and health economist decided to include an equal proportion of each cancer stage and target 40% recruitment in the lowest quintile. We recruit from Southampton, which is in the top 17% most deprived local authorities in the UK, and wider region. MODERNISED is sponsored by University Hospital Southampton (UHS) and managed by Southampton Clinical Trials Unit (SCTU). Timelines for delivery This is a 24-month project. Notably SME Proteotype and the Project's Southampton Team already collaborate via an Innovate-funded grant developing another Proteotype product that uses the same laboratory assay. Anticipated impacts Enlighten portability and rapid turnaround can revolutionise how cancer screening is done in deprived communities, closing the stage-at-diagnosis gap.