Framework to Select Multi-Cancer Detection Assays in the National Cancer Institute’s Vanguard Study
Elyse LeeVan, Amanda L. Skarlupka, Christos Patriotis, Wendy S. Rubinstein, Paul F. Pinsky, Wade E. Bolton, Anthony Dickherber, David B. Edelman, Lyndsay N. Harris, Hormuzd A. Katki, Erin Lavik, A. Martin, Mary Jane Ong, Philip C. Prorok, David F. Ransohoff, Sarah M. Temkin, Lori M. Minasian
Abstract
BACKGROUND: The Cancer Screening Research Network is a new clinical trials network funded by the NCI. The first Cancer Screening Research Network study, the Vanguard Study (VS), will assess the feasibility of using multi-cancer detection (MCD) tests in future randomized controlled trials. METHODS: This article describes the framework NCI developed to engage MCD assay developers, evaluate emerging technologies using biobank reference sets, and select fit-for-purpose MCD assays for inclusion in the VS. RESULTS: NCI evaluated 23 technologically diverse MCD assays, all utilizing machine learning and artificial intelligence components. Nine assays underwent blinded performance evaluations using specimens from three biobanks. Assay developers were provided with independent assessments of their assays, which enabled them to make further assay refinements to enhance performance. The assay selection process resulted in participation by two assay companies in the VS. CONCLUSIONS: NCI created a fair and transparent process to streamline the evaluation of assay performance and to select promising assays for clinical research and public health initiatives. IMPACT: Significant resources are required for large-scale cancer screening trials; therefore, promising technologies must be prioritized for inclusion in a definitive trial. NCI's assay selection framework can be used and repurposed by other networks and institutions.