Guardant Health Receives ADLT Status From CMS for Shield Blood Test

Approval demonstrates unique value of Shield test for CRC screening and improves Medicare pricing

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the Shield™ blood test for colorectal cancer (CRC) screening. The U.S. Food and Drug Administration (FDA) approved Shield in July 2024 as the first blood test for primary CRC screening. Medicare already covers the test.

The CMS determination confirms that the Shield test meets the criteria for ADLT status, which is reserved for innovative products that provide novel clinical information that cannot be obtained by any other method, and for FDA-approved tests. Obtaining ADLT status initiates a specific, market-based approach to pricing the test for Medicare patients. The Shield test will be reimbursed at the amount of $1,495 for Medicare patients during the initial nine-month ADLT period beginning April 1, 2025.

During the initial ADLT period, Guardant Health will collect, assess and submit private-payer payment rate data for the test, the median of which will be used by CMS to determine the Medicare pricing, beginning January 1, 2026. This rate will be the payment amount for Shield from January 1, 2026, to December 31, 2027.

“Obtaining ADLT status reinforces the value that our Shield blood test for colorectal cancer screening brings to patients, offering a more pleasant and convenient option that can help increase the overall screening rate and improve outcomes,” said AmirAli Talasaz, Guardant Health co-CEO. “We’ve already seen strong adoption by providers with Medicare-covered patient populations. This designation from CMS and a more favorable Medicare rate will help us bring the innovation of Shield to more patients coast-to-coast by accelerating our investments in building our commercial infrastructure.”

The Shield blood test is FDA approved for primary non-invasive screening for colorectal cancer in average-risk individuals age 45 and older. For more information, visit www.ShieldCancerScreen.com.

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.

Guardant Health 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.

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