Multi-Cancer Early Detection tests (MCEDs) hold promise to change how we screen for cancers. The gold standard for evaluating cancer screening tests are expensive and lengthy randomized clinical trials with a cancer mortality endpoint. A major randomized trial of a leading MCED assay will deliver results on reductions in late-stage incidence in 2026. We suggest assembling relevant data to allow population implementation of these tests, including data from case-control data on test characteristics, real-world implementation studies, modeling studies, post market studies, and the collection of non-mortality endpoints of primary importance to patients.

The NHS Galleri trial is an unprecedented cancer screening trial that is ongoing in the UK. It will evaluate the effect of annual screening new multicancer screening test—the Galleri test—on the incidence of late-stage disease among the targeted cancers over a follow-up interval of only 3 years. We predict the outcome of the Galleri trial using a model of cancer natural history that projects late-stage reduction using a test with a specified sensitivity for each targeted cancer. We present a range of uncertainty over the predicted results and examine how the predictions might change under different trial durations and timeliness of treatment for screen-detected disease.

Detecting cancer at an early stage requires regular screening. Establishing trajectories of biomarkers over time as part of multi-cancer early detection blood tests improves performance compared to a single threshold tests. Evidence to this effect will be presented.

Our team conducted a survey amongst healthcare providers (HCPs), payers, and patients within the U.S. health system to understand the current utilization of cancer screening tests and the anticipated barriers to widespread adoption of blood-based MCED tests. The results indicated significant enthusiasm for MCED adoption, but also highlighted a number of barriers that still exist before the value proposition of MCEDs can be truly realized.

Even once they have FDA approval, blood-based screening tests face multiple policy barriers that can impact their adoption as a cancer screening tool. This session will discuss the regulatory and reimbursement challenges that influence patient access to and provider adoption of innovative screening tests and explore potential solutions.