Health equity challenges facing testing, evaluation, and implementation of multi-cancer early detection tests.

Abstract

e15051 Background: The development of Multi Cancer Early Detection markers may herald a new approach to screening and detection of multiple cancers simultaneously via various biological assays. At each stage of development and evaluation of these tests, and especially at implementation, challenges to ensuring equitable access to advancements in cancer prevention, screening, diagnosis, and treatment arise. Diverse research study populations and methods are key when investigating the efficacy of screening tools in practice. Health equity encompasses all parts of research study and design, particularly increasing diversity in research study populations and methods to reflect intended populations of study and document how MCEDs may impact demographic groups differently. Methods: The MCED Consortium is a not-for-profit group of volunteers, advisors, and companies from the US and the UK spanning a wide range of expertise in biomarker evaluation and implementation, with a special focus on clinical practice, health equity, and communication ( https://www.mced.info/ ). We are developing recommendations for the evaluation of test utility, appropriate prioritized populations for screening or early detection, downstream actions in health systems, achieving health equity, and addressing the communication challenges related to this new, potentially revolutionary generation of tests. Results: The MCED consortium has made recommendations in the domains of investigator, participant level, and study design features. The Consortium also has identified key questions for MCED researchers and users regarding equitable access, acceptance, and follow-up. An emerging challenge relates to the release of these tests to selected populations via the laboratory-developed test pathway; which will almost certainly disproportionately increase access to insured and higher socioeconomic status populations. Conclusions: In this MCED Consortium presentation, we will discuss the barriers to ensuring adequate clinical trial diversity and evaluation of MCEDs and how to optimize equity during their current and near-term distribution.