Summary Assessment
| Dimension | Cancerguard | Galleri |
|---|---|---|
| Biomarker classes | Multi (ctDNA mutations + methylation + proteins) | Single (cfDNA methylation) |
| Cancer types | 50+ | 50+ |
| Overall sensitivity (best published) | ~64–68% (dev studies) | ~51–66% (validation studies) |
| Specificity | 97.4% | 99.6% |
| CSO accuracy | Not yet prospectively validated at scale | 92% (PATHFINDER 2) |
| Regulatory stage | LDT only; Breakthrough designation | LDT + PMA submitted Jan 2026 |
| Key pivotal trial | ASCEND-2 (~11K) + DETECT-A | PATHFINDER 2 (~35K) + NHS-Galleri (140K RCT) |
| Price | $689 | $949 |
| Access | Quest Diagnostics network | Direct order/clinician |
Bottom line: Galleri has an enormously stronger evidence base, a near-complete FDA PMA submission, and a higher specificity. Cancerguard’s multi-analyte architecture is scientifically interesting and its headline sensitivity numbers (from development studies) look favorable, but those numbers have not yet been stress-tested in a large-scale prospective interventional trial. Speculatively, if Exact Sciences can replicate their development-study performance in real-world populations, the multi-biomarker approach could ultimately outperform single-analyte methylation — but that remains unproven, and the specificity gap (97.4% vs. 99.6%) will need to be addressed to be competitive for guideline inclusion.