• Blood-based Shield Multi-Cancer Detection (MCD) test exhibits high specificity, clinically meaningful sensitivity and strong cancer signal of origin accuracy
• Results informed National Cancer Institute's selection of Shield MCD test for highly anticipated Vanguard Study

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, presented 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. The study was presented at the 2025 American Association for Cancer Research (AACR) 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.

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).

“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 website. For more information on the NCI Vanguard Study, please visit the study website.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

* Esophageal and Gastric cancers are combined in Table 1.

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"This strong data reinforces the potential of the Shield test to detect multiple cancers earlier through a simple blood draw."