• Running on Guardant Infinity™ smart liquid biopsy platform, new Guardant360 test covers over 10 times more genes, including all guideline-recommended genomic biomarkers across advanced solid tumors, and quantifies tumor burden with 10 times higher sensitivity
• Upgraded test covered by Medicare and major private payers for comprehensive genomic profiling of all advanced solid tumors

PALO ALTO, Calif. / Jul 23, 2024 / Business Wire / Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the launch of a major upgrade to its market-leading Guardant360 liquid biopsy test. The new enhanced test evaluates biomarkers in 739 genes in total, which is 10 times more cancer biomarkers than the previous version of Guardant360 evaluated. The test can also identify an extensive array of emerging biomarkers to precisely characterize cancer and can quantify disease burden at much higher sensitivity. The biomarkers, or gene alterations, detected by the test enable oncologists to identify the targeted treatment strategies that are most effective for patients with advanced cancer.

The expanded number of biomarkers identified by the upgraded Guardant360 test includes all guideline-recommended genomic biomarkers across advanced solid tumors and emerging biomarkers that may impact treatment planning in the future. The test runs on the Guardant Infinity smart liquid biopsy platform, which uses a novel genomic and epigenomic sequencing technology that provides exceptional sensitivity and accurately quantifies disease burden tumor fraction at 10 times lower levels than the previous version of Guardant360. Results are provided in 7 to 10 days.

“Guardant360 is the leading liquid biopsy test for patients with advanced cancer, and this major upgrade through our Guardant Infinity smart liquid biopsy platform enables us to give oncologists a much more complete view of cancer,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “Our updated test provides much broader gene panel coverage and analyzes both currently actionable and emerging biomarkers not available on any other liquid biopsy test. This upgrade will mark the beginning of a new chapter of tumor profiling that will be as profound as the original introduction of comprehensive profiling, informing cancer care teams about the optimal treatment strategy for their patients by giving them many more precision treatment options that can help improve their outcomes.”

The updated Guardant360 test is 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 test is also covered by all major insurers, representing over 300 million covered lives.

Guardant360 tests have been used by more than 15,000 oncologists and are widely accepted for blood-based comprehensive genomic profiling, with more than 500 peer-reviewed publications and over 500,000 tests performed to date.

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. 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.