Guardant Health receives coverage from UnitedHealthcare for Guardant360® CDx blood test as companion diagnostic in advanced lung and breast cancer

• Guardant360 CDx test is now covered under UHC commercial policies for all FDA-approved biomarker confirmation indications in patients with advanced or metastatic breast or non-small cell lung cancer
• Nation’s largest health insurer now covers Guardant360 CDx liquid biopsy for comprehensive genomic profiling for all enrolled patients

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that UnitedHealthcare (UHC) now covers the Guardant360® CDx liquid biopsy test for patients enrolled in its commercial policies for all FDA-approved companion diagnostic indications. The test is used by oncologists as a companion diagnostic to assess if patients are eligible for a targeted therapy for advanced or metastatic breast or non-small cell lung cancer (NSCLC).

The Guardant360 CDx test was the first blood test approved by the FDA for comprehensive genomic profiling for all solid tumors, and it is now FDA-approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer. In December 2019, Guardant360 became the first liquid biopsy to be broadly covered by Medicare for use across the vast majority of advanced solid tumors. The new policy coverage by UnitedHealthcare is in addition to existing coverage of the Guardant360 CDx test under UHC Medicare Advantage policies for comprehensive genomic profiling of all solid tumors.

“We are pleased that UnitedHealthcare has taken this important step to make comprehensive genomic profiling more accessible to patients with advanced lung and breast cancer,” said Helmy Eltoukhy, Guardant Health co-CEO. “The biomarker identification available through the Guardant360 CDx blood test can enable oncologists to quickly identify patients who may benefit from a therapy targeted to their specific type of mutation to help improve their outcomes. We believe this important decision will help expand patient access to genomic profiling across additional tumor types and healthcare plans in the coming years.”

This year, an estimated 236,740 adults in the U.S. will be diagnosed with lung cancer, which is the leading cause of cancer death worldwide.¹ Non-small cell lung cancer, the most common type in the U.S., represents about 82% of all lung cancer.² Worldwide, female breast cancer has now surpassed lung cancer as the most commonly diagnosed cancer and is the fifth leading cause of death. This year, an estimated 287,850 women in the United States will be diagnosed with invasive breast cancer, and 51,400 women will be diagnosed with non-invasive (in situ) breast cancer.³ Due to the expanded coverage decision, the Guardant360 CDx test will now be covered for comprehensive genomic profiling for all lives covered by UnitedHealthcare, the largest U.S. national health insurer in commercial and Medicare Advantage markets.

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.

About Guardant360 CDx

For oncologists, the FDA-approved Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

The first FDA-approved blood test for complete genomic testing, Guardant360 CDx is approved as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO^® (osimertinib), RYBREVANT^® (amivantamab-vmjw), ENHERTU^® (fam-trastuzumab deruxtecan-nxki) or LUMAKRAS™ (sotorasib). It is also FDA approved to identify advanced breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU™ (elacestrant). For more information, visit guardant360cdx.com.

Since being introduced, the Guardant360 test 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 250,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 230 million lives.

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 any current and periodic reports filed with 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.

References

1. www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics#. Accessed February 6, 2023.
2. www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics#. Accessed February 6, 2023.
3. www.cancer.net/cancer-types/breast-cancer/statistics. Accessed February 6, 2023.

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