Cell-free DNA methylation — multi-cancer early detection (MCED) — research (ESCAT III)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | BIO-CFDNA-METHYLATION-MCED |
|---|---|
| Type | Biomarker |
| Aliases | GRAIL GalleriGalleriMCEDcfDNA methylation MCEDmethylation-based MCEDmulti-cancer early detectionМетилювання позаклітинної ДНК — мульти-онкологічне раннє виявлення (MCED) — дослідницький рівень (ESCAT III) |
| Status | reviewed 2026-05-18 | pending_clinical_signoff |
| Diseases | DIS-CRC |
| Sources | SRC-CIVIC |
Biomarker Facts
| Biomarker type | composite_score |
|---|---|
| Measurement | MethodPlasma cfDNA targeted methylation sequencing (commercial: GRAIL Galleri ~100,000 methylation regions); classifier returns binary cancer-signal-detected + cancer-signal-of-origin (CSO) tissue prediction Unitscategorical (signal-detected | signal-not-detected) + predicted tissue-of-origin (single or paired prediction) |
| Related biomarkers | None declared |
Notes
Multi-cancer early-detection (MCED) class — plasma cfDNA methylation patterns classify cancer signal + predict tissue-of-origin across 50+ cancer types in a single blood draw. Largest published evidence: GRAIL PATHFINDER prospective study (Schrag et al., Lancet 2023): in 6,621 adults ≥50, MCED signal-detection rate ~1.4%, true-positive cancer detection ~38% of signal-positives; CSO accuracy ~88% for the primary site. Klein 2021 (CCGA Substudy 3) at 99.5% specificity: sensitivity 51.5% across 50 cancers, 67.6% in stages I-III for pre-specified 12 cancer types. ESCAT III evidence tier (clinical trial / large prospective cohort, not yet level-1 outcome data). Galleri available in US as a laboratory-developed test (LDT) — not FDA-approved (May 2026). NHS-Galleri trial (140,000 participants, UK) ongoing — primary endpoint stage-shift in detected cancers (results expected 2026-2028). USPSTF has NOT issued an MCED recommendation. Critical limitations: (1) negative result does NOT rule out cancer (sensitivity gaps especially for early-stage); (2) high false-positive rate at population scale → downstream imaging cascade burden; (3) lead-time bias not yet quantified; (4) CSO ambiguity in ~1...
Used By
Actionability
BMA-CFDNA-MCED-MULTI-CANCER-SCREENING- Plasma cell-free DNA methylation classifiers (Galleri-style multi-cancer early detection...
Biomarker
BIO-CTDNA-MRD-POST-TREATMENT- ctDNA-based minimal residual disease (MRD) — post-treatment monitoring