OnCo
drugsProductPhase 3

Galleri

A blood test screening for more than 50 cancers at once, before the FDA in September 2026.

Galleri is GRAIL's methylation-based MCED. Available as an LDT since 2021 (~$949). PATHFINDER 2 (25,000+ participants) and NHS-Galleri (140,000 randomised) underpin the PMA submitted January 2026; FDA advisory committee 23 September 2026. Cancer signal detected in ~1% of screened adults with PPV ~40-60% in PATHFINDER 2; sensitivity for stage I disease is low.

Schematic of the modality · Multi-cancer early detection blood test · not a molecule; see the Multi-cancer early detection (MCED) page
Mechanism, step by step
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1.Blood is drawn and cell-free DNA extracted

Modality
Multi-cancer early detection blood test
Mechanism
Targeted cfDNA methylation sequencing with machine-learned cancer signal and tissue-of-origin classifier.
Where it is approved
USunder reviewEUnot filedUKunder reviewJPCNAUcompare regions →

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Regulatory

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  1. May 2018DesignationUS

    FDA Breakthrough Device designation source

  2. Jun 2021Filing / dealUS

    Launched as a laboratory-developed test source

  3. 29 Jan 2026Filing / dealUS

    Final PMA module submitted source

  4. 23 Sept 2026Advisory committeeUS

    FDA Molecular and Clinical Genetics Panel meeting source

Cost & access

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Cost & access
CountryReimbursement
United StatesNot covered by Medicare (pending FDA decision and the MCED Screening Coverage Act); some employer and Medicare Advantage programmes cover
United KingdomNot available on the NHS; trial access via NHS-Galleri

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Galleri
intervention: Galleri
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Key papers

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Latest papers

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Literature trend19 papers in the last 12 months+19% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Galleri" OR ABSTRACT:"Galleri") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Galleri, not a curated reading list.

Connected

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