Prospective registrational study expected to enroll nearly 10,000 patients in 36 months

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today the enrollment of the first patient in the SHIELD (Screening for HIgh-frEquency maLignant Disease) LUNG study, a nearly 10,000-patient prospective, registrational study to evaluate the performance of its next-generation Guardant SHIELD blood test in detecting lung cancer in high-risk individuals ages 50-80. The study is anticipated to run in approximately 100 centers in the United States and Europe.

Lung cancer is the leading cause of death among both men and women in the U.S. It is also the leading cause of cancer death among men, and the second leading cause of cancer death among women worldwide.¹ The U.S. Preventive Services Task Force recommends yearly lung cancer screening using a low-dose computed tomography (CT) scan for people ages 50 to 80 years old who are at high risk for lung cancer because of their smoking history, but who don’t have signs or symptoms.² Despite these recommendations, only 14% of people eligible for a low-dose CT scan are up to date with screening recommendations.³

“Symptoms of lung cancer don’t appear until the disease is already at an advanced stage. That’s why it’s so important to find lung cancer early, before symptoms start,” said Craig Eagle, MD, Guardant Health chief medical officer. “Unfortunately, many people do not follow recommended screening guidelines for lung cancer. We believe a simple blood test could help improve screening rates and detect lung cancer early, when it can most easily be treated.”

Eligible participants for the SHIELD LUNG study will include people between the ages of 50 and 80 who are current or former smokers and undergo standard lung cancer screenings using low-dose CT scanning. Enrollment is expected to be complete within 36 months, and if the study is successful, the data will support a pre-market approval (PMA) submission to the U.S. Food and Drug Administration (FDA). Additional information about the SHIELD LUNG study is available on clinicaltrials.gov (NCT05117840).

“The SHIELD LUNG study is the second large-scale screening study initiated by Guardant Health in just over two years to evaluate the performance of our blood tests for early cancer detection. Our unique combination of medical, clinical and operational expertise, in partnership with our clinical investigators and study sites, allows us to move forward rapidly with enrollment for this very important study,” said AmirAli Talasaz, Guardant Health co-CEO. “Lung cancer screening is known to save lives. This study will add to the growing body of evidence that supports the use of our blood tests to screen for cancer early. It also reinforces our deep commitment to providing patients with a simple blood test that is accurate and easier than the current standard of care, to catch lung cancer at the earliest stages where there can be better patient outcomes.”

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 GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. These tests fuel development of the company’s screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

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, 2020 and in its other reports filed with the Securities and Exchange Commission. 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. Torre LA, Siegel RL, Jemal A. Lung Cancer Statistics. Advances in Experimental Medicine and Biology. 2016; 893:1-19. 10.1007/978-3-319-24223-1_1
2. U.S. Preventative Services Task Force. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening. Accessed online December 17, 2021.
3. Zahnd WE, Eberth JM. Lung cancer screening utilization: a behavioral risk factor surveillance system analysis. Am J Prev Med. 2019;57(2):250-255. doi:10.1016/j.amepre.2019.03.015

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