Navigating Complexity: Perspectives on Risk Assessment in the Era of New Blood-Based Tests for Early Cancer Detection
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.
Authors
- Peter Kühn (ORCID: https://orcid.org/0000-0003-2629-4505)
- Stephanie A. Sanchez (ORCID: https://orcid.org/0000-0003-2946-0281)
- Christina A. Clarke (ORCID: https://orcid.org/0000-0002-7515-2549)
- Michelle Beidelschies (ORCID: https://orcid.org/0000-0002-6344-0674)
- Jody M. Hoyos (ORCID: https://orcid.org/0009-0001-7295-3412)
- Emma B. Alme
- Nancy Krunic
- Ryan W. Serra (ORCID: https://orcid.org/0000-0001-8037-0666)
- Mark Stewart (ORCID: https://orcid.org/0000-0002-4847-0736)
- Tomasz M. Beer (ORCID: https://orcid.org/0000-0001-5600-9993)
- David Morgenstern (ORCID: https://orcid.org/0000-0003-0554-3947)
- Wendy S. Rubinstein (ORCID: https://orcid.org/0000-0002-8790-9959)
- Girish Putcha (ORCID: https://orcid.org/0000-0002-6559-620X)
- Jonathan P. Beer
- Lauren C. Leiman
- Dorys Lopez Ramos (ORCID: https://orcid.org/0009-0008-1415-3135)
- Breeana L. Mitchell
- Victoria M. Raymond (ORCID: https://orcid.org/0000-0001-5223-0981)
- Jerry Lee (ORCID: https://orcid.org/0000-0003-1515-0952)
- Elissa Quinn (ORCID: https://orcid.org/0000-0001-7952-2562)
- Kathryn Lang
- Eric A. Klein
Institutions
- University of Southern California (US)
- National Institutes of Health (US)
- Prevent Cancer Foundation (US)
- Mechanical Solutions (United States) (US)
- Bristol-Myers Squibb (United States) (US)
- CCC Diagnostics (United States) (US)
- Menlo School (US)
- Guardant (United States) (US)
- American University for Humanities (US)
- Exact Sciences (United States) (US)
- Meta (United States) (US)
- Precision for Medicine (United States) (US)
- Novartis (United States) (US)
- Building Blocks Learning Academy (US)
- Natera (United States) (US)
- Freenome (United States) (US)
- Bristol-Myers Squibb (Sweden) (SE)
- ATUM (United States) (US)
- Grail (United States) (US)
- National Cancer Institute (US)
- CS Diagnostics (DE)
- AstraZeneca (United States) (US)
- Quest Diagnostics (United States) (US)
- Friends of Cancer Research (US)
- Seminary of the Southwest (US)
Publication Details
- Journal
- Clinical Cancer Research
- Published
- 2025-04-08
- DOI
- https://doi.org/10.1158/1078-0432.ccr-24-4269
- Citations
- 1
- Primary Topic
- BRCA gene mutations in cancer
- Type
- article
- Field-Weighted Citation Impact
- 1.82