GOZILA Study Published in Nature Medicine Shows Patients With Advanced Cancer Who Receive Liquid Biopsy-Guided Treatment Using Guardant360 CDx Survive Twice as Long

• In study of more than 4,000 patients with advanced gastrointestinal tumors, 24% were able to receive targeted treatment based on genomic profiling results from blood test
• Study findings are expected to advance liquid biopsy-guided cancer treatment to help improve outcomes for more patients

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the peer-reviewed journal Nature Medicine published results from the SCRUM-Japan GOZILA study confirming that selecting targeted therapy on the basis of Guardant360^® CDx liquid biopsy results may significantly extend survival for patients with advanced cancer.

The study, led by a research group out of National Cancer Center Hospital East in Kashiwa, Japan, investigated the effects of personalized treatment based on results of the Guardant360 CDx test in 4,037 patients with advanced cancer. The results showed that 24% of participants were able to receive targeted treatment tailored to them based on comprehensive genomic profiling results from the test, which analyzes 74 cancer-related genes. The patients who received targeted treatment guided by liquid biopsy results lived approximately twice as long as those who did not.

"Compared to conventional tissue biopsies, liquid biopsies have several advantages: they are less invasive for patients, allow for repeated testing, and can simultaneously examine cancer characteristics from various parts of the body. However, until now, it was unclear whether treatment selection using liquid biopsies actually helped improve patient outcomes,” said Yoshiaki Nakamura, M.D., Ph.D., chief, International Research Promotion Office, Department of Gastroenterology and Gastrointestinal Oncology at National Cancer Center Hospital East in Kashiwa, Japan, and a co-lead author of the study. “The GOZILA study is the first to demonstrate the survival-extending effect of liquid biopsy-based personalized cancer treatment on a large scale across various cancers. The results of this study have the potential to bring about a paradigm shift in cancer treatment."

Selecting therapies for patients based on the liquid biopsy results enabled study investigators to identify targeted treatment options they could not discern using traditional methods. The researchers then followed the progress of treated patients and analyzed their treatment response and survival time. Patients who received targeted therapy had a median survival of 18.6 months compared to 9.9 months for those who did not.

“The GOZILA study adds significantly to the body of evidence supporting the clinical utility of the Guardant360 CDx liquid biopsy to guide therapy selection in advanced cancer,” said Craig Eagle, M.D., Guardant Health chief medical officer. “These study results confirm, across a large study population and multiple tumor types, that personalized therapy guided by liquid biopsy has the potential to significantly extend patient survival.”

About Guardant360 CDx

The first FDA-approved comprehensive liquid biopsy for all advanced solid tumors, Guardant360 CDx provides oncologists with genomic profiling results from a simple blood draw in less than seven days to pair patients with targeted therapies. The test detects guideline-recommended actionable biomarkers across all four major alteration classes, with a panel that assesses 74 genes.¹ Guardant360 CDx is FDA-approved as a companion diagnostic (CDx) for multiple targeted therapies in non-small cell lung cancer (NSCLC) and is the only FDA-approved CDx to identify patients eligible for breast cancer therapy targeting ESR1 mutations.

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.² 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, 2023, and any current and periodic 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.

Footnotes

1. As a professional service, Guardant360 CDx reports 74 genes. This report has not been reviewed or approved by the U.S. FDA.
2. The complete portfolio of Guardant Health products may not be available in all regions.

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