• With new coverage from Anthem Blue Cross and Blue Shield, Aetna and Humana, Guardant360 CDx/Guardant360 liquid biopsy test now covered by all major commercial health insurers
• Only blood test approved by FDA as companion diagnostic for ORSERDU™ (elacestrant), Guardant360 CDx gains coverage by Aetna and Humana to identify eligible patients with advanced breast cancer prior to initiation of treatment

PALO ALTO, Calif. / May 17, 2023 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that it has received new commercial health plan coverage for the Guardant360 liquid biopsy test from Anthem Blue Cross and Blue Shield, Aetna and Humana. With this additional coverage, Guardant360 CDx/Guardant360 is now covered for comprehensive genomic profiling by all major U.S. commercial health insurers.

The Guardant360 CDx/Guardant360 test analyzes circulating tumor DNA (ctDNA) to provide comprehensive genomic profiling, or tumor mutation profiling, for all solid tumors. It is used by healthcare professionals to detect actionable cancer biomarkers in a patient’s blood that may help inform their therapy selection.

“We are pleased that these major health insurers have taken this step to improve access to comprehensive genomic profiling for their patients with advanced cancers,” said Helmy Eltoukhy, Guardant Health co-CEO. “The Guardant360 blood test can help oncologists quickly identify the specific mutations driving cancer in order to select the most appropriate therapy. We believe this recognition of the clinical value of our test will result in improved outcomes for more patients with cancer.”

In February, Guardant Health announced that it had received coverage from UnitedHealthcare for Guardant360 CDx as companion diagnostic in advanced lung and breast cancer. Over the past few weeks, the Guardant360 test has received commercial policy coverage from three additional major U.S. health insurers.

The Guardant360 test received coverage under Anthem Blue Cross and Blue Shield commercial health insurance policies for complete genomic profiling of any solid tumor to identify actionable biomarkers to inform therapy selection. Anthem operates in 14 states and provides 32 million individuals with access to more than 1.7 million doctors and hospitals nationwide through Anthem brands and the greater Blue Cross Blue Shield network.

In addition, Aetna confirmed commercial coverage of the Guardant360 CDx test as a companion diagnostic to identify estrogen receptor 1 (ESR1) gene mutations in persons with advanced breast cancer being considered for treatment with ORSERDU (elacestrant).

The Guardant360 CDx test also received commercial medical policy coverage from Humana for use as a companion diagnostic to identify individuals diagnosed with advanced or metastatic, ER-positive, HER2-negative breast cancer whose disease progressed following at least one line of endocrine therapy and are eligible for treatment with ORSERDU (elacestrant).

Since it was introduced in 2014, Guardant360 CDx/Guardant360 has become widely accepted for blood-based comprehensive genomic profiling, with more than 350 peer-reviewed publications. It has been trusted by more than 12,000 oncologists, with more than 300,000 tests ordered to date.

In December 2019, Guardant360 became the first liquid biopsy to be broadly covered by Medicare and many private payers for use across the vast majority of advanced solid tumors. With the additional coverage by Anthem Blue Cross and Blue Shield, Aetna and Humana, total health insurer coverage for the Guardant360 test now represents over 300 million lives.

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 GuardantINFINITY™ tests for advanced-stage cancer, and Guardant Reveal™ for early-stage cancer. The Guardant Health screening portfolio, including the commercially launched Shield™ 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, 2022, 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.