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. 2025 Jun 13;31(12):2267-2270.
doi: 10.1158/1078-0432.CCR-24-4269.

Navigating Complexity: Perspectives on Risk Assessment in the Era of New Blood-Based Tests for Early Cancer Detection

Christina A Clarke #  1 , Breeana L Mitchell #  2 , Emma Alme  3 , Jonathan P Beer  4 , Tomasz M Beer  5 , Michelle A Beidelschies  5 , Jody Hoyos  6 , Eric A Klein  1 , Peter Kuhn  7 , Nancy Krunic  8 , Kathryn Lang  9 , Jerry S H Lee  7 , Dorys Lopez Ramos  10 , David Morgenstern  11 , Girish Putcha  12 , Elissa Quinn  13 , Victoria M Raymond  3 , Wendy S Rubinstein  14 , Stephanie A Sanchez  2 , Ryan W Serra  15 , Mark D Stewart  16 , Lauren C Leiman  10
Affiliations

Navigating Complexity: Perspectives on Risk Assessment in the Era of New Blood-Based Tests for Early Cancer Detection

Christina A Clarke et al. Clin Cancer Res. .

Abstract

In recent years, there has been a surge in the development of new, blood-based, single- and multi-cancer detection tests (SCD and MCD), which can detect cancer signals prior to the onset of symptoms or clinical diagnosis of cancer. Recognizing the need for consensus definitions and standardized evidence development frameworks for these new types of blood tests, the Early Detection and Screening Working Group of the Blood Profiling Atlas in Cancer Consortium, a collaborative initiative dedicated to advancing standards and best practices, developed and published a lexicon for liquid biopsy-based SCD and MCD tests. During the preparation of the lexicon, the group recognized challenges with regard to the definitions of key terms and concepts describing absolute and RR assessment of intended use populations for cancer screening tests. This article captures the working group's discussions on (i) risk assessment including considerations for adapting historical SCD risk terminology like "average risk" and "elevated risk" to MCD tests, (ii) the implications of this terminology for describing intended use populations, and (iii) the existing gaps in evidence for determination of absolute risks.

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Conflict of interest statement

C.A. Clarke reports other support from GRAIL during the conduct of the study. B.L. Mitchell reports personal fees from Natera outside the submitted work. J.P. Beer reports ownership of Bristol Myers Squibb, Novartis, and Vertex shares and other support from Exact Sciences during the conduct of the study as well as other support from Exact Sciences outside the submitted work. M.A. Beidelschies reports personal fees from Exact Sciences outside the submitted work. E.A. Klein reports other support from GRAIL during the conduct of the study. N. Krunic reports other support from Novartis during the conduct of the study as well as other support from Novartis outside the submitted work. K. Lang reports employment with device manufacturers in early cancer detection space. J.S.H. Lee reports other support from miRoncol outside the submitted work. D. Morgenstern reports personal fees and other support from DELFI Diagnostics outside the submitted work. G. Putcha reports personal fees from Natera and Optum Genomics outside the submitted work. E. Quinn reports personal fees from AstraZeneca outside the submitted work. V.M. Raymond reports personal fees from Guardant Health during the conduct of the study. S.A. Sanchez reports other support from Natera and Roche outside the submitted work. R.W. Serra reports other support from Quest Diagnostics, Illumina, and Exact Sciences outside the submitted work. No disclosures were reported by the other authors.

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