Plasma cell-free DNA methylation classifiers (Galleri-style multi-cancer early detection...

Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.

ID	`BMA-CFDNA-MCED-MULTI-CANCER-SCREENING`
Тип	Клінічна застосовність
Статус	переглянуто 2026-05-18 \| потрібне рев’ю клінічної застосовності
Хвороби	`DIS-CRC`
Джерела	`SRC-CIVIC`

Дані про клінічну застосовність

Біомаркер	`BIO-CFDNA-METHYLATION-MCED`
Варіант	Cell-free DNA methylation signature — multi-cancer signal
Хвороба	`DIS-CRC`
Рівень ESCAT	IIIA
Підсумок доказів	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.

Нотатки

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.

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