Navigating Complexity: Perspectives on Risk Assessment in the Era of New Blood-Based Tests for Early Cancer Detection
Christina A Clarke1, Breeana L Mitchell2, Emma Alme3
1GRAIL, Inc., Menlo Park, California.
Summary
New blood tests for early cancer detection require standardized definitions. This work addresses challenges in defining risk categories for single- and multi-cancer detection tests to improve population assessment.
Area of Science:
- Oncology
- Biomarkers
- Medical Diagnostics
Background:
- Advancements in blood-based single- and multi-cancer detection tests (SCD and MCD) enable early cancer signal identification.
- Existing consensus definitions and evidence frameworks are insufficient for these novel liquid biopsy tests.
- The Blood Profiling Atlas in Cancer Consortium established a working group to address these standardization needs.
Purpose of the Study:
- To discuss challenges in defining key terms for risk assessment in cancer screening tests.
- To adapt terminology for risk stratification (e.g., 'average risk,' 'elevated risk') for multi-cancer detection tests.
- To clarify implications of risk terminology for defining intended use populations and identify evidence gaps.
Main Methods:
- Review and discussion by the Early Detection and Screening Working Group of the Blood Profiling Atlas in Cancer Consortium.
- Analysis of challenges in defining absolute and relative risk (RR) assessment for intended use populations.
- Examination of existing evidence gaps for absolute risk determination in cancer screening.
Main Results:
- Identified challenges in applying historical single-cancer detection risk terminology to multi-cancer detection tests.
- Highlighted the need for clear definitions of intended use populations based on risk stratification.
- Recognized significant gaps in evidence for determining absolute risks for screening populations.
Conclusions:
- Standardized definitions and risk assessment frameworks are crucial for the accurate implementation of blood-based cancer detection tests.
- Further research is needed to establish robust evidence for absolute risk determination and refine terminology for multi-cancer screening.
- Consistent language is essential for describing populations and ensuring appropriate use of these emerging diagnostic tools.
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