Plasmazellfreie DNA-Methylierungs-Klassifikatoren (Galleri-Stil Multi-Krebs-Früherkennung...
Deterministische Ansicht der Quelle YAML Entität. Klinische Autorität bleibt mit den zitierten Quell-IDs und Rezensenten Sign-off Zustand.
| ID | BMA-CFDNA-MCED-MULTI-CANCER-SCREENING |
|---|---|
| Art | Therapeutische Relevanz |
| Status | reviewed 2026-05-18 | actionability review required |
| Erkrankungen | DIS-CRC |
| Quellen | SRC-CIVIC |
Fakten zur Handlungsfähigkeit
| Biomarker | BIO-CFDNA-METHYLATION-MCED |
|---|---|
| Variante | Zellfreies DNA-Methylierungssignatur — Multi-Krebs-Signal |
| Erkrankung | DIS-CRC |
| ESCAT-Stufe | IIIA |
| Zusammenfassung der Beweise | Plasma cell-free DNA methylation classifiers (Galleri-style multi-cancer early detection / MCED) detect a cancer signal across 50+ tumour types with tissue-of-origin prediction. PATHFINDER (Schrag 2023) prospectively demonstrated feasibility (specificity ~99.5%, PPV ~38%) but MCED is NOT yet endorsed by USPSTF, NCCN, or ESMO as screening. SYMPLIFY (NHS, 2023) evaluated symptomatic-patient triage. DIS-CRC anchor reflects the best-characterized signal class; the assay is intentionally multi-cancer and not disease-specific. Research-level evidence (ESCAT IIIA / CIViC C); cannot replace established screening (FIT, colonoscopy, mammography, LDCT) per current guidance. |
Anmerkungen
STUB pending two-Co-Lead signoff. MCED (Grail Galleri, Exact Sciences Cancerguard, others) is positioned as an ADJUNCT to USPSTF-endorsed screening, NOT a replacement. Outside CHARTER §2 non-commercial scope to recommend any specific brand; render layer must surface "investigational / research-only" framing. No surveillance/screening Indication entity exists yet that ingests an MCED-positive signal — pending a future IND-MCED-POSITIVE-WORKUP entity scoped to coordinate tissue-of-origin workup (PET/CT, site-directed endoscopy/imaging) after a positive MCED call. Until that exists, indications: [] is intentional. Anchor disease set to DIS-CRC because GRAIL CCGA sub-study reported strong signal in CRC and CRC is the most clinically-tractable post-MCED workup target; the underlying assay is multi-cancer and a future multi-tumor index entity may be appropriate.
Verwendet von
Keine Rückverweise im YAML-Korpus gefunden.