# Performance of a multi-biomarker class, multi-cancer early detection (MCED) blood test in a prospectively collected cohort

Source: https://onco.cc/key-papers/paper-cancerguard-mp-classifier-cebp-2026/  
OnCo record `paper-cancerguard-mp-classifier-cebp-2026` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Exact Sciences' development study of the methylation and protein classifier behind Cancerguard: it found about half of cancers overall but about one in seven stage I cancers.

## Summary

Gainullin and colleagues assessed a methylation and protein (MP) classifier in a prospectively collected multi-centre case-control set of 6,352 samples (1,438 cancer, 4,914 non-cancer) across 21 tumour organ types, split between training and test sets. At 98.5% specificity, overall sensitivity was 50.9%, with 15.4% at stage I, 26.1% at stages I and II combined, 38.0% at stage II, 67.8% at stage III and 85.5% at stage IV. Excluding breast and prostate cancers, overall sensitivity was 56.8% and stage I sensitivity 17.2%. A somatic mutation reflex for borderline samples was explored.

## Fields

- Kind: Key paper
- Last checked: 2026-10-29
- Journal: Cancer Epidemiology, Biomarkers & Prevention
- Year: 2026
- DOI: 10.1158/1055-9965.EPI-26-0541
- Authors: Gainullin VG, Manesse M, Zhuang F, et al.
- Findings: Overall sensitivity 50.9% at 98.5% specificity.; Stage I 15.4%, stage II 38.0%, stage III 67.8%, stage IV 85.5%.; Without breast and prostate: overall 56.8%, stage I 17.2%.
- What it means: 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.
- Caveats: Case-control; no positive predictive value in a screening population.; Development classifier, not the commercial product's threshold.; Authors employed by Exact Sciences.

## Sources

- CEBP 2026: methylation and protein classifier: https://doi.org/10.1158/1055-9965.EPI-26-0541
- PubMed: https://pubmed.ncbi.nlm.nih.gov/42826075/

## Connected records

- fronts: [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [Cell-free DNA methylation tests](https://onco.cc/technologies/cfdna-methylation-testing/), [Multi-cancer early detection (MCED)](https://onco.cc/technologies/mced/), [Proteomics & phosphoproteomics](https://onco.cc/technologies/proteomics/)
- drugs: [Cancerguard](https://onco.cc/drugs/cancerguard/)
- companies: [Exact Sciences (Abbott)](https://onco.cc/companies/exact-sciences/)
- journals: [Cancer Epidemiology, Biomarkers & Prevention](https://onco.cc/journals/cancer-epidemiology-biomarkers-prevention/)

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