# Shield MCD (Shield Multi-Cancer Detection)

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

## TL;DR

Guardant Health's blood test for ten cancers, offered in the United States as an add-on report to its bowel cancer blood test and chosen by the US National Cancer Institute for its first randomised study of such tests.

## Summary

Shield MCD extends Guardant Health's Shield blood test from colorectal cancer to multiple cancers by reading cell-free DNA methylation, and reports a cancer signal origin. Guardant lists ten cancers (bladder, colorectal, breast, prostate, oesophageal, gastric, liver, lung, ovarian and pancreatic) in its March 2026 Asia launch release; the FDA Breakthrough Device designation of 3 June 2025 covers eight (bladder, colorectal, oesophageal, gastric, liver, lung, ovarian and pancreatic).

Performance, Guardant's own conference data (case-control, no peer-reviewed paper found): at AACR 2025, 778 samples, 98.5% specificity, 60% overall sensitivity and 89% cancer signal origin accuracy, with 21% sensitivity for prostate and 45% for breast cancer; at ASCO 2025, 98.6% specificity and 75% sensitivity with 92% accuracy for a primary or secondary signal origin. No stage I figure or positive predictive value in a screening population has been published.

Regulation and availability: in the US the MCD report is added to a Shield colorectal blood draw when the physician opts in, nationally from October 2025; Guardant's FAQ states it is not part of the FDA-approved Shield device and has not been cleared or approved by the FDA. From April 2026 Guardant offers it as a laboratory-developed test to Manulife customers in Hong Kong, Singapore and the Philippines. No US list price for the MCD report was found. The NCI selected it, with ClearNote Health's Avantect, for the randomised Vanguard feasibility study (NCT06995898).

## Fields

- Kind: Treatment
- Status: emerging
- Last checked: 2026-10-29
- Also known as: Shield Multi-Cancer Detection; Shield multi-cancer
- Tags: test; mced; evidence:insufficient
- Brand: Shield MCD
- Modality: Multi-cancer early detection blood test (cell-free DNA methylation)
- Mechanism: A methylation-based reading of cell-free DNA from the same blood draw as Guardant's Shield colorectal test, reporting a cancer signal and a predicted cancer signal origin.

## Notes

- Evidence grade insufficient for the claim that taking this test reduces late-stage diagnosis or cancer deaths: no randomised trial of it has reported either outcome, and its published performance comes from case-control or single-arm studies. The only randomised result for any multi-cancer test, NHS-Galleri, did not show fewer stage III or IV cancers.
- What a result means: a positive result is a reason for further tests, not a diagnosis; a negative result does not rule cancer out and does not replace the screening tests that have been shown to work (bowel, breast, cervical and, where eligible, lung screening).
- Guardant's two conference figures (60% and 75% sensitivity) come from different sample sets and should not be read as a trend.

## Sources

- Guardant: Breakthrough Device designation (3 June 2025): https://investors.guardanthealth.com/press-releases/press-releases/2025/FDA-Grants-Breakthrough-Device-Designation-to-Guardant-Healths-Shield-Multi-Cancer-Detection-MCD-Test/
- Guardant: Shield MCD launch in Asia with Manulife (16 March 2026): https://investors.guardanthealth.com/press-releases/press-releases/2026/Guardant-Health-Launches-Shield-Multi-Cancer-Detection-MCD-Test-in-Multiple-Markets-in-Asia-with-Manulife-Partnership/default.aspx
- NCI selects two assays for the Vanguard Study: https://prevention.cancer.gov/news-and-events/news/nci-selects-two-assays-vanguard-study-multi-cancer-detection-tests

## Connected records

- drugs: [Avantect Multi-Cancer Detection Test](https://onco.cc/drugs/avantect-mcd/), [Galleri](https://onco.cc/drugs/galleri/), [Shield](https://onco.cc/drugs/shield/)
- technologies: [Cell-free DNA methylation tests](https://onco.cc/technologies/cfdna-methylation-testing/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Multi-cancer early detection (MCED)](https://onco.cc/technologies/mced/)
- companies: [Guardant Health](https://onco.cc/companies/guardant-health/)
- terms: [Positive predictive value (PPV)](https://onco.cc/terms/ppv/), [Screening](https://onco.cc/terms/screening/)
- trials: [Vanguard Study (NCI Cancer Screening Research Network)](https://onco.cc/trials/vanguard-study/)

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