Guardant Health Announces Collaboration With AstraZeneca to Develop Companion Diagnostic to Identify Patients With ESR1-mutated Metastatic Breast Cancer

Collaboration employing Guardant360 CDx assay is first to use ctDNA comprehensive genomic profiling blood test for early detection of resistance due to ESR1 mutation prior to first-line therapy progression

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today it has entered into a collaboration with AstraZeneca to pursue the development, regulatory approval and commercialization of the Guardant360® CDx blood test as a companion diagnostic to identify patients with ESR1-mutated metastatic breast cancer. The initiative is part of a larger strategic collaboration investigating the use of liquid biopsy as a tool to inform early therapy intervention.

The collaboration is one of the first to explore the potential of a comprehensive genomic profiling ctDNA (circulating tumor DNA) assay to identify mutation-driven resistance to a prior line of therapy in metastatic breast cancer. The Guardant360 CDx liquid biopsy test is being used to identify patients with detectable ESR1 mutations in the SERENA-6 phase III clinical trial, which is evaluating camizestrant, a next-generation oral selective estrogen receptor degrader (ngSERD) being developed by AstraZeneca, in combination with CDK4/6 inhibitors versus aromatase inhibitors in combination with CDK4/6 inhibitors in patients with HR-positive, HER2-negative metastatic breast cancer.

“We’re pleased to collaborate with AstraZeneca on this important study for breast cancer patients,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “We look forward to exploring the potential benefit of early comprehensive genomic profiling using a simple blood draw, which can provide faster results than a tissue biopsy and enable clinicians to consider earlier intervention with the goal of achieving improved patient outcomes.”

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield^TM test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter.

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, 2021 and in its other reports filed with 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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