- Study addressing feasibility of using multi-cancer detection tests in future trials aims to enroll up to 24,000 participants
- Shield MCD reviewed by FDA as part of NCI's investigational device exemption (IDE)
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that patient enrollment has begun in the National Cancer Institute (NCI)'s Vanguard Study to evaluate emerging multi-cancer detection (MCD) technology. Guardant's Shield MCD test was selected for use in the four-year study, which aims to enroll up to 24,000 patients and evaluate the use of MCD tests-blood tests that can screen for several types of cancer simultaneously-in future randomized controlled trials.
Guardant's Shield MCD test was chosen for the study based on the overall performance of its Shield platform in detecting 10 cancer types, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver and gastric. The data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The Vanguard study was initiated following review and approval by the U.S. Food and Drug Administration (FDA) as part of the NCI's submission for an investigational device exemption (IDE).
"New screening technology like the Shield MCD test has the potential to detect multiple cancers earlier through a simple blood draw," said Craig Eagle, MD, Guardant Health Global Chief Medical Officer. "The earlier we can screen and diagnose cancers, the more options we can bring to patients and ultimately the more lives we can save. The Vanguard Study is a critical step in research to evaluate the role of this breakthrough technology in helping reduce cancer deaths."
The Vanguard Study, conducted by the Cancer Screening Research, a new NCI-sponsored clinical trials network, is enrolling individuals ages 45-75 who do not currently have cancer and who have not received a cancer diagnosis in the past five years. All participants will be offered standard cancer screenings as part of their care. Results from the study will inform the design of a much larger randomized controlled trial to evaluate the use of MCD tests for cancer screening.
"Initiation of the Vanguard Study is an exciting milestone, as we look to evaluate a new way to screen for cancer," said Scott Ramsey, M.D., Ph.D., director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch Cancer Center and principal investigator for the Vanguard Study. "The study will help us learn more about multi-cancer detection tests and assess whether they can help people from all backgrounds find cancer early, when it may be easier to treat."
The Shield MCD test recently received Breakthrough Device Designation from the FDA for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA's Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review.
For more information, please visit the Fred Hutch Cancer Center Vanguard Study website.
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, 2024, and in its other 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.
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Investor Contact:
Zarak Khurshid
investors@guardanthealth.com
Media Contact:
Meaghan Smith
press@guardanthealth.com
