# Cancerguard

Source: https://onco.cc/drugs/cancerguard/  
OnCo record `cancerguard` (Treatment). 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.

## Summary

Cancerguard launched in September 2025 as a laboratory-developed test priced for self-pay, built on the multi-biomarker approach validated in the Falcon Registry and DETECT-A studies (the latter, with Johns Hopkins, was the first prospective interventional study of a multi-cancer blood test). Unlike Galleri it does not predict where a cancer is, so a positive result triggers whole-body imaging. As an LDT it is regulated through CLIA rather than the FDA, a status confirmed when the FDA's 2024 LDT rule was vacated in 2025. No randomised trial has yet shown that a multi-cancer blood test reduces deaths.

## Fields

- Kind: Treatment
- Status: emerging
- Last checked: 2026-09-10
- Tags: test
- 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

- 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.

## Sources

- Exact Sciences: Cancerguard: https://www.exactsciences.com/

## Connected records

- drugs: [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/)
- 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/)

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JSON: https://onco.cc/api/v1/entities/cancerguard.json