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Review
. 2024 Jul 24;14(8):925.
doi: 10.3390/life14080925.

Shifting the Cancer Screening Paradigm: Developing a Multi-Biomarker Class Approach to Multi-Cancer Early Detection Testing

John B Kisiel  1 , Jon O Ebbert  1 , William R Taylor  1 , Catherine R Marinac  2 , Omair A Choudhry  3 , Seema P Rego  3 , Tomasz M Beer  3 , Michelle A Beidelschies  3
Affiliations
Review

Shifting the Cancer Screening Paradigm: Developing a Multi-Biomarker Class Approach to Multi-Cancer Early Detection Testing

John B Kisiel et al. Life (Basel). .

Abstract

Guideline-recommended screening programs exist for only a few cancer types. Although all these programs are understood to lead to reductions in cancer-related mortality, standard-of-care screening tests vary in accuracy, adherence and effectiveness. Recent advances in high-throughput technologies and machine learning have facilitated the development of blood-based multi-cancer cancer early detection (MCED) tests. MCED tests are positioned to be complementary to standard-of-care screening and they may broaden screening availability, especially for individuals who are not adherent with current screening programs and for individuals who may harbor cancers with no available screening options. In this article, we outline some key features that should be considered for study design and MCED test development, provide an example of the developmental pathway undertaken for an emerging multi-biomarker class MCED test and propose a clinical algorithm for an imaging-based diagnostic resolution strategy following MCED testing.

Keywords: DNA methylation; DNA mutational analysis; biomarkers; cell-free nucleic acids; early detection of cancer; liquid biopsy; tumor.

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Conflict of interest statement

John Kisiel receives support from a sponsored research agreement between Exact Sciences Corporation and Mayo Clinic. John Kisiel and William Taylor are inventors of Mayo Clinic intellectual property in the field of early cancer detection, licensed to Exact Sciences. Jon Ebbert and Catherine Marinac serve on the Exact Sciences Corporation Advisory Board and receive honoraria and travel support from Exact Sciences Corporation. Catherine Marinac serves on the Steering Committee for Natera, Inc. Authors Omair Choudhry, Seema Rego, Tomasz Beer, and Michelle Beidelschies are employed by Exact Sciences Corporation and have stock ownership.

Figures

Figure 1
Figure 1
Average 5-year survival rate by stage at diagnosis based on SEER data.
Figure 2
Figure 2
Proposed clinical algorithm for diagnostic resolution through imaging following an MCED test. * Abbreviations: CT: Computed Tomography; FDG: Flourine-18 Fluorodeoxyglucose; MCED: Multi-Cancer Early Detection; PET: Positron Emission Tomography; USPSTF: United States Preventive Services Task Force. * This clinical algorithm is not meant to replace clinical standard of care. Suggested pathways are intended to encourage clinicians to ask questions and consider important factors as they define the ideal diagnostic strategy for their patients.
See this image and copyright information in PMC

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