Predictive Performance of Cell-Free Nucleic Acid-Based Multi-Cancer Early Detection Tests: A Systematic Review.
1Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, United States.
Clinical Chemistry
|October 4, 2023
Summary
Multi-cancer early detection (MCED) blood tests show promise for identifying various cancers. While specificity is high, sensitivity varies by cancer type and stage, requiring further validation in asymptomatic individuals.
Area of Science:
- Oncology
- Genomics
- Molecular Diagnostics
Background:
- Multi-cancer early detection (MCED) tests aim to reduce cancer morbidity and mortality by detecting multiple cancer types from a single blood test.
- Most MCED assays utilize cell-free tumor DNA (CF-DNA) analysis, offering potential screening for high-mortality cancer sites.
- The clinical utility of MCED tests is not yet established, necessitating demonstration of their clinical validity.
Approach:
- A systematic review was conducted on cell-free nucleic acid-based MCED tests.
- Literature search of PubMed from January 2017 to February 2023 using relevant MeSH terms.
- 20 publications were included after assessing 1811 initial records.
Key Points:
- Most reviewed studies assessed cancer cases at the time of diagnosis.
- MCED tests demonstrated high specificity (≥95%) with a median overall sensitivity of 73%.
- Sensitivity varied by cancer type and stage, generally increasing with disease progression.
Conclusions:
- Few studies have evaluated the clinical validity of MCED tests to date.
- Current evidence shows high specificity but variable sensitivity, dependent on cancer type and stage.
- Future research should focus on testing MCEDs in the intended population of asymptomatic individuals.
