• Combining pretreatment genomic profiling and postoperative molecular residual disease (MRD) testing identified patient groups with estimated two-year recurrence-free survival ranging from 78% to 9%

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that ESMO Open has published results from PRECISION, a prospective multicenter observational study in Japan that enrolled 130 patients and evaluated complementary blood-based approaches for assessing recurrence risk in patients undergoing curative-intent surgery for colorectal cancer metastases.

The study paired pretreatment comprehensive genomic profiling (CGP) using Guardant360^® Liquid with postoperative MRD detection using Guardant Reveal^® approximately four weeks after surgery. The paired assessment identified three groups with markedly different outcomes, showing that information about tumor mutations before treatment and residual circulating tumor DNA (ctDNA) detection after surgery together provide improved prognostic stratification.

“The application of ctDNA analysis has evolved dramatically in this decade. However, the clinical utility of preoperative CGP and postoperative MRD testing for guiding perioperative treatment decisions for resectable colorectal oligometastases (CRM) has been unclear,” said Shin Kobayashi, MD., PhD., Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan, a principal investigator of the PRECISION study. “PRECISION suggests that combining pretreatment tumor genomic profiling with postoperative MRD assessment may provide complementary prognostic information. This could help patients and their care teams better understand the post-surgery risk of recurrence and inform the future development of more personalized treatment strategies, although these findings should be prospectively verified in an interventional study.”

Key findings included:

• Pretreatment blood-based profiling was feasible in nearly all eligible patients. Guardant360 Liquid detected genomic alterations in 97% of patients, 64% of whom had genomic profiles that were associated with greater than 4-fold higher hazard of recurrence or death.
• Postoperative blood-based MRD detection was evaluable in 99% of patients who underwent surgery. MRD was detected in 31% of patients and also significantly associated with worse outcomes (4.7-fold increase in hazard of recurrence or death).
• Combining pretreatment genomic profiling with postoperative MRD testing identified three distinct risk groups, with estimated two-year recurrence-free survival of 78% among patients with neither adverse feature, 40% among those with one, and 9% among those with both.

Establishing the feasibility of preoperative liquid-based CGP paired with postoperative liquid-based MRD testing is especially meaningful, as tissue-based testing is often infeasible due to limited biopsy accessibility pretreatment and longer turnaround times post-surgery.

“These findings illustrate how Guardant’s liquid biopsy tests can provide a comprehensive view of cancer—informing meaningful outcomes that can benefit clinical practice,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “The study also affirms our commitment to supporting patients throughout the care continuum.”

Globally, colorectal cancer (CRC) is the third most common type of cancer and the second leading cause of cancer-related mortality. These findings indicate the potential of a dual approach to ctDNA analysis to identify reliable biomarkers and inform the development of personalized perioperative chemotherapy for the advanced stages of CRC.

About Guardant360^® Liquid

Guardant360 Liquid is a blood-based test that analyzes tumor DNA fragments circulating in the blood (cfDNA) to identify genetic mutations in advanced solid tumors, helping oncologists find targeted therapies. It offers an alternative to tissue biopsies, providing CGP to guide personalized treatment for a wide range of solid cancers including lung, breast, colorectal, and prostate cancer. Guardant360 Liquid is guideline-complete across all advanced solid tumors, and has been clinically validated in more than 1,500 publications and research abstracts.

About Guardant Reveal^®

Guardant Reveal is a tissue-free liquid biopsy test that detects MRD and monitors recurrence in early-stage colorectal, breast, and lung cancers, helping oncologists guide treatment decisions. In addition to MRD detection, Reveal can be used for late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights.

The first clinical-validation study of pan-cancer chemotherapy monitoring published in The Journal of Liquid Biopsy showed that Guardant Reveal predicts long-term patient benefit up to 18 months earlier than standard clinical measures.

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.

Guardant Health 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, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. 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.

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