Guardant Health Shield Platform Selected for Inclusion in National Cancer Institute’s Vanguard Study to Evaluate Emerging Technologies for Multi-Cancer Detection

• Guardant Health Shield multi-cancer detection test selected on basis of strong performance in predicting presence of cancers and cancer tissue of origin
• Pilot study by National Cancer Institute’s Cancer Screening Research Network will inform design of future research evaluating use of multi-cancer detection blood tests to screen for cancer

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the National Cancer Institute (NCI) has selected the company’s Shield™ multi-cancer detection (MCD) test for use in its Vanguard study, which will address the feasibility of using MCD tests in future clinical trials related to cancer screening. MCD tests are blood tests that can screen for several types of cancers simultaneously.

In February 2024, the National Institutes of Health (NIH) launched the Cancer Screening Research Network (CSRN), which is funded by the NCI, part of NIH, to evaluate emerging cancer screening technologies, including MCD tests. The network will support research to investigate how to identify and diagnose cancers earlier, when they may be easier to treat.

As an initial effort, CSRN is launching the Vanguard Study, a four-year pilot study that will enroll up to 24,000 people to inform the design of a much larger randomized controlled trial evaluating the use of MCD tests for cancer screening. In its studies, the network aims to reach diverse populations, including underserved populations, that are receiving routine care in a variety of health care settings.

“Despite recent advances in screening technology, there are still many types of cancer that are difficult to detect with existing technologies until the late stages, when they become much more challenging to treat,” said AmirAli Talasaz, Guardant Health co-CEO. “We are excited about the potential for early detection of multiple cancers through a simple blood draw with our Shield MCD test. The Vanguard study is an important step in demonstrating the value of our technology.”

Of the many companies whose tests were evaluated by NCI to be considered for inclusion in the Vanguard study, Guardant Health was selected to be one of two participants, based on the overall performance of its Shield platform. The NCI provided a blinded reference set to verify the platform’s performance in detecting 10 cancer types, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver and gastric. Results from the NCI verification study are expected to be published in early 2025.

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 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, 2023, 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.