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. 2025 Feb;42(2):18758592241297849.
doi: 10.1177/18758592241297849. Epub 2025 Apr 2.

Multi-cancer early detection tests: Attributes for clinical implementation

Jon O Ebbert  1 , Ernest T Hawk  2 , Christopher V Chambers  3 , Margaret A Tempero  4 , Elliot K Fishman  5 , Jospeh E Ravenell  6 , Tomasz M Beer  7 , Seema P Rego  7
Affiliations
Free article

Multi-cancer early detection tests: Attributes for clinical implementation

Jon O Ebbert et al. Cancer Biomark. 2025 Feb.
Free article

Abstract

Guideline-recommended screening programs exist for only a few single-cancer types, and these cancers represent less than one-half of all new cancer cases diagnosed each year in the U.S. In addition, these "single-cancer" standard of care (SoC) screening tests vary in accuracy, adherence, and effectiveness, though all are generally understood to lead to reductions in cancer-related mortality. Recent advances in high-throughput technologies and machine learning have facilitated the development of blood-based multi-cancer early detection (MCED) tests. The opportunity for early detection of multiple cancers with a single blood test holds promise in addressing the current unmet need in cancer screening. By complementing existing SoC screening, MCED tests have the potential to detect a wide range of cancers at earlier stages when patients are asymptomatic, enabling more effective treatment options and improved cancer outcomes. MCED tests are positioned to be utilized as a complementary screening tool to improve screening adherence at the population level, to broaden screening availability for individuals who are not adherent with SoC screening programs, as well as for those who may harbor cancers that do not have SoC testing available. Published work to date has primarily focused on test performance relating to sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). MCED tests will require approval through the pre-market approval pathway from the United States Food and Drug Administration. Additional studies will be needed to demonstrate clinical utility (i.e., improvements in health outcomes) and establish optimal implementation strategies, (i.e., testing intervals), follow-up and logistics of shared decision making. Here, we propose core attributes of MCED testing for which clinical data are needed to ideally position MCED testing for widespread use in clinical practice.

Keywords: accuracy; adherence; clinical implementation; effectiveness; multi-cancer early detection.

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Conflict of interest statement

Declaration of conflicting interestsJ.O. Ebbert reports honoraria from Exact Sciences Corporation and MedIn Cell, a consulting/advisory role at Exact Sciences Corporation and Applied Aerosol Technologies, patients/royalties/other intellectual property interests from Applied Aerosol Technologies and Lin Health. Open payments link https://openpaymentsdata.cms.gov/physician/1016828E.T. Hawk reports employment at MD Anderson Cancer Center; a leadership role at AACR (Cancer Prevention Research senior editor); an uncompensated consulting/advisory role at Guardant Health; CATCH Global Foundation - Board of Directors (uncompensated); grant funding from NCI and Exact Sciences Corporation and the Cancer Prevention & Research Institute of Texas; honoraria and/or payment for travel, accommodations, expenses related to advisory or ad hoc review activities for Mayo Clinic Comprehensive Cancer Center Kimmel Comp. Cancer Center at Johns Hopkins, Cancer Institute of New Jersey/Rutgers, Roswell Park Cancer Institute, O'Neal Comp. Cancer Center at University of Alabama, Birmingham, Hollings Cancer Center at Med University of South Carolina, Lurie Comp. Cancer Center at Northwestern University (ad hoc), Fred and Pamela Buffet Cancer Center at the University of Nebraska, University of Kansas Comp. Cancer Center, Simmons Comp. Cancer Center at UT Southwestern, Huntsman Cancer Institute at the University of Utah, Knight Cancer Institute at Oregon Health Sciences University, and Helmholtz Foundation (Germany for DKFZ).C.V. Chambers reports employment at Agenus (family member); stock ownership at Amgen and Novartis (family member); research funding from Exact Sciences Corporation and Clinetic.M.A. Tempero reports honoraria from Exact Sciences Corporation; a consulting/advisory role at Astellas Pharma Global Development Inc., AstraZeneca, BeiGene, Bristol Myers Squibb, ElmediX, Geron Corporation, Global Bio Access fund, Guardant Health, Immodulon Therapeutics Ltd, IPSEN Biopharma, Inc., Merus, Mirati Therapeutics Inc., PEPTOMYC, S.L., Regeneron, and RenovoRx.E.K. Fishman reports a consulting role at Exact Sciences Corporation and grant funding from General Electric and Siemens. He is also the founder of HipGraphics and a consultant to Imaging Endpoints.J.E. Ravenell reports a consulting/ advisory role at Exact Sciences Corporation.T. M. Beer reports employment and stock ownership at Exact Sciences Corporation; stock ownership at Salarius Pharmaceutical, Osteologic, and Osheru; and consulting/advisory roles at Arvinas and AstraZeneca.S.P. Rego reports former employment at Exact Sciences Corporation; employment at Adela, Incorporated; and stock ownership at Exact Sciences Corporation and Adela, Inc.

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