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Exact Sciences' multi-cancer blood test, sold since 2025 as a lab test that has not been through FDA approval; it says whether a cancer signal is present but not where, so a positive result leads to scans.
Cancerguard launched on 10 September 2025 as a prescription-only laboratory-developed test for adults aged 50 to 84 without a cancer diagnosis in the previous three years, at a launch price of $689 stated by Exact Sciences. Exact describes it as reading ctDNA methylation and proteins as biomarker classes and says it can help detect over 50 cancer types and subtypes; its site states that it is not FDA cleared or approved. It does not predict where a cancer is, so a positive result is followed by an imaging-guided work-up. Exact Sciences has been wholly owned by Abbott since March 2026.
The evidence. Exact's own development figures (company statements, not peer-reviewed for the launched test) are 68% sensitivity across six deadly cancers, 64% excluding breast and prostate, at 97.4% specificity. The only peer-reviewed stage-by-stage figures (Gainullin et al., Cancer Epidemiology, Biomarkers & Prevention 2026) are for the development methylation and protein classifier in 6,352 case-control samples: 50.9% overall sensitivity at 98.5% specificity, with 15.4% at stage I, 38.0% at stage II, 67.8% at stage III and 85.5% at stage IV. The approach descends from CancerSEEK and the DETECT-A study with Johns Hopkins and Geisinger, the first prospective interventional study of a multi-cancer blood test. The Falcon Registry (NCT06589310) is following up to 25,000 people tested in practice. No randomised trial has yet shown that a multi-cancer blood test reduces deaths.
Plasma assay combining cell-free DNA methylation and protein biomarkers across multiple classes, reporting a cancer signal without a tissue-of-origin call, followed by imaging work-up.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | - | US$689 (launch price stated by Exact Sciences, September 2025) | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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It is the only peer-reviewed stage-by-stage figure for the Cancerguard approach, and it describes a development classifier at 98.5% specificity, not the launched test, which Exact Sciences says runs at 97.4% specificity.
A blood test can find early, treatable cancers in people who feel well, including cancers for which no screening exists. It is not a replacement for mammography or colonoscopy but a possible addition. Larger randomised trials are needed to show benefit outweighs harm.
The proof of principle for multi-cancer blood tests that include pancreas; the sensitivity figures come from known cancers, not from screening.
Query for this drug: (TITLE:"Cancerguard" OR ABSTRACT:"Cancerguard") 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 Cancerguard, not a curated reading list.
Shares Shield, Positive predictive value (PPV), Galleri, Screening and the tag mced.
Shares CancerSEEK, Detection and localization of surgically resectable cancers with a multi-analyte blood test, DETECT-A: a blood test plus PET-CT found treatable cancers in 10,000 women with no symptoms, Multi-cancer early detection (MCED) and the tag mced.
Shares Proteomics & phosphoproteomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tag mced.
Shares Proteomics & phosphoproteomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tag mced.
Shares Proteomics & phosphoproteomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tag mced.
Shares Proteomics & phosphoproteomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tag mced.
Shares DNA methylation profiling, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tag mced.
Shares Proteomics & phosphoproteomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tag mced.
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