Multi-cancer early detection test sensitivity for cancers with and without current population-level screening options.
Level 4 - case-series / case-control
Post-hoc subgroup analysis of an observational diagnostic study
PubMed 36316952 · doi:10.1177/03008916221133136
What was done
This was a post-hoc analysis of cancer participants from the third Circulating Cell-free Genome Atlas (CCGA) substudy (NCT02889978). The authors evaluated the diagnostic sensitivity of a blood-based multi-cancer early detection (MCED) test across three groups: solid screened tumors (breast, cervical, colorectal, prostate), solid unscreened tumors, and hematologic malignancies. Test sensitivity was evaluated across all stages, specifically across clinical stages I–III, overall, and in participants aged ≥50 years.
What was found
Across all cancer stages, aggregate test sensitivity was 34% for solid screened tumors, 66% for solid unscreened tumors, and 55% for hematologic malignancies (with similar values in participants aged ≥50 years). When restricted to stages I to III, aggregate sensitivity was 27% in solid screened tumors, 53% in solid unscreened tumors, and 60% in hematologic malignancies. Among 18 solid unscreened cancer types, sensitivity exceeded 50% in 13 of 18 cancers (72%) and exceeded 75% in 8 of 18 cancers (44%).
Why it matters
The findings show that circulating cell-free DNA testing achieves higher sensitivity in cancers that currently lack standard population screening methods than in routinely screened solid cancers, indicating a potential role in supplementing established screening regimens.
Limits
The abstract lacks total sample size numbers and confidence intervals. As a post-hoc analysis in a pre-diagnosed cancer cohort, it does not assess real-world screening performance, specificity, positive predictive value, stage shifts, overdiagnosis, or mortality benefit. Sensitivity for stage I alone is not reported separately from stages II and III.
Cited by
- context The Galleri liquid biopsy test from GRAIL has an overall sensitivity of roughly 20% for stage 1 and stage 2 breast cancers, but reaches 75% to 80% sensitivity for stage 1 and 2 ER/PR-negative breast cancers.