On April 29, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported data today from a study showing that its methylation-based Shield multi-cancer detection (MCD) test demonstrated high specificity and clinically meaningful sensitivity across ten tumor types,* while also providing information to guide clinical diagnostic evaluation (Press release, Guardant Health, APR 29, 2025, View Source [SID1234652335]). The study was presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. Results of the study served as the basis for the selection of the blood-based Shield MCD test by the National Cancer Institute (NCI) for inclusion in its upcoming Vanguard Study evaluating emerging MCD technology.
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Data presented in the oral session titled "Evaluation of a plasma cell-free DNA methylation-based multi-cancer detection test" showed that the Shield MCD test demonstrated 98.5% specificity and 60% overall sensitivity, with 74% sensitivity across the six most aggressive cancers (defined as those with the shortest survival rates), including esophageal-gastric, hepatocellular, lung, ovarian and pancreas. The test also demonstrated 89% accuracy for primary or secondary cancer signal of origin (CSO) prediction.
"There are still many types of cancer that are difficult to detect with existing technologies until the late stages. This strong data reinforces the potential of the Shield test to detect multiple cancers earlier through a simple blood draw," said AmirAli Talasaz, Guardant Health co-founder and co-CEO. "This study was a critical step in evaluating this innovative technology as a new screening option we can bring to patients to help reduce cancer deaths."
The blinded case-control study evaluated samples from 778 individuals with either a known diagnosis of cancer or who were cancer free (by self-report). Age range of participants was 40-78 years (median age 62); 55% were female and 79% were white. Across the ten cancer types, overall sensitivity per type ranged from 96% (esophageal-gastric (stomach)) to 21% (prostate) at 98.5% specificity (Table 1).
Table 1: Overall and per cancer Sensitivity and CSO Accuracy Results at 98.5% Specificity (n=403)
Sensitivity, %
Primary or Secondary CSO
Accuracy, %
Overall, 375
60%
89%
Bladder, 13
62%
75%
Breast, 86
45%
92%
Colorectal, 41
83%
94%
Esophageal-Gastric (Stomach) 25
96%
92%
Hepatocellular, 16
94%
73%
Lung, 57
67%
97%
Ovarian, 20
70%
93%
Pancreas, 59
68%
80%
Prostate, 59
21%
83%
"Impressively, this initial cohort analysis of the Shield MCD test met overall performance expectations, with particularly strong sensitivity in the six most aggressive cancers for which early detection is key," said William Greenleaf, Ph.D., study co-author, consultant for Guardant Health and professor of genetics at Stanford University School of Medicine. "These results show this blood-based MCD test holds promise for detection of multiple cancer types, and thus for detection in asymptomatic adults when treatment is more effective."
The full data abstract and a list of all abstracts being presented at the meeting can be found on the AACR (Free AACR Whitepaper) website. For more information on the NCI Vanguard Study, please visit the study website.