# Cancerguard

Source: https://onco.cc/drugs/cancerguard/  
OnCo record `cancerguard` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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 Exact's own development figures (company statements, not peer-reviewed for the launched test) are 68% sensitivity across six deadly cancers, 64% excluding breast and prostate, at 97.4% specificity.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.

## Fields

- Kind: Test
- Status: emerging
- Last checked: 2026-10-29
- Tags: mced; evidence:insufficient
- Brand: Cancerguard
- Modality: Multi-cancer early detection blood test (laboratory-developed)
- Mechanism: 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.

## Notes

- Evidence grade insufficient for the claim that it reduces late-stage diagnosis or cancer deaths: no randomised trial of it has reported either outcome; published performance is case-control, and the one randomised trial of any multi-cancer test, NHS-Galleri, did not show fewer stage III or IV cancers.
- What a result means: a positive signal starts a diagnostic work-up with scans; most people with a positive result will not turn out to have cancer, and a negative result does not replace mammograms, colonoscopy or other proven screening.
- The 15.4% stage I figure is from the development classifier at 98.5% specificity, not the launched test's 97.4% specificity setting.

## Sources

- Exact Sciences: Cancerguard launch (10 September 2025): https://www.exactsciences.com/newsroom/press-releases/exact-sciences-launches-cancerguard-first-of-its-kind-multi-cancer-early-detection-blood-test
- Gainullin et al., CEBP 2026: https://doi.org/10.1158/1055-9965.EPI-26-0541
- ClinicalTrials.gov NCT06589310 (Falcon Registry): https://clinicaltrials.gov/study/NCT06589310
- Exact Sciences: Cancerguard: https://www.exactsciences.com/

## Connected records

- drugs: [CancerSEEK](https://onco.cc/drugs/cancerseek/), [Galleri](https://onco.cc/drugs/galleri/), [Shield](https://onco.cc/drugs/shield/)
- technologies: [DNA methylation profiling](https://onco.cc/technologies/methylation-profiling/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Multi-cancer early detection (MCED)](https://onco.cc/technologies/mced/), [Proteomics & phosphoproteomics](https://onco.cc/technologies/proteomics/)
- companies: [Exact Sciences (Abbott)](https://onco.cc/companies/exact-sciences/)
- terms: [FDA laboratory-developed test (LDT) rule](https://onco.cc/terms/fda-ldt-rule/), [Positive predictive value (PPV)](https://onco.cc/terms/ppv/), [Screening](https://onco.cc/terms/screening/)
- trials: [ASCEND (CancerSEEK case-control collection)](https://onco.cc/trials/ascend-cancerseek/), [Falcon Registry (Exact Sciences multi-cancer test real-world evidence)](https://onco.cc/trials/falcon-registry/)
- key papers: [DETECT-A: a blood test plus PET-CT found treatable cancers in 10,000 women with no symptoms](https://onco.cc/key-papers/paper-detect-a-science-2020/), [Detection and localization of surgically resectable cancers with a multi-analyte blood test](https://onco.cc/key-papers/paper-cohen-cancerseek-multi-analyte-blood-test-science-2018/), [Performance of a multi-biomarker class, multi-cancer early detection (MCED) blood test in a prospectively collected cohort](https://onco.cc/key-papers/paper-cancerguard-mp-classifier-cebp-2026/)

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