• Upgraded gene panel on tissue genomic profiling test covers 498 biomarkers, including guideline-recommended genes
• Operational improvements streamline workflow and shorten time to results
• Upgraded test covered by Medicare for comprehensive genomic profiling of all advanced solid tumors

PALO ALTO, Calif. / Jun 04, 2024 / Business Wire / Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the launch of a new version of its Guardant360 TissueNext test that expands the number of genes it identifies in a tumor tissue sample to 498. These genes, or cancer biomarkers, enable oncologists to identify the targeted therapies or treatment strategies that are most effective for patients with advanced cancer. In addition to the panel expansion, Guardant has improved the test’s operational workflow for a faster turnaround time.

The new Guardant360 TissueNext test will be covered for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service, based on coverage conveyed by Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX®), under the existing local coverage determination.

“The launch of the new Guardant360 TissueNext test is another step forward in our mission to conquer cancer with data,” said Helmy Eltouky, Guardant Health chairman and co-CEO. “In addition to identifying guideline-recommended biomarkers, the upgraded test now provides more comprehensive gene coverage, so oncologists can make better informed decisions about the optimal treatment strategy for their patients with advanced cancer and help improve their outcomes.”

Guardant360 TissueNext identifies clinically relevant actionable biomarkers in tumor tissue to help oncologists select patients with advanced cancer who may benefit from biomarker-informed treatment. Results are provided in less than two weeks.

The test, which first received Medicare coverage in March 2022, is part of Guardant’s comprehensive portfolio of blood- and tissue-based genomic profiling tests, including Guardant360 CDx, the first liquid biopsy test approved by the FDA for comprehensive genomic profiling of all solid tumors. The Guardant360 TissueNext test can be ordered alone or in combination with Guardant360 CDx to support guideline-recommended complementary liquid and tissue genomic profiling testing for advanced breast and lung cancer.

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 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 helping doctors select the best treatment for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Forward-Looking Statements

This news 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 news 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 in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this news 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.