Guardant Health’s FDA-approved Shield™ Blood Test Now Commercially Available in U.S. as a Primary Screening Option for Colorectal Cancer

• FDA approval announced earlier this week makes Shield first blood test that is approved for primary screening of colorectal cancer and meets coverage requirements for Medicare reimbursement
• Commercial launch of Shield and CMS coverage make blood-based screening option more accessible to millions of individuals at average risk for the disease

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield^™ blood test, recently approved by the U.S. Food and Drug Administration (FDA), is now covered by Medicare and is commercially available in the U.S. as the first FDA-approved blood test for primary colorectal cancer (CRC) screening.

The Centers for Medicare & Medicaid Services (CMS) now covers the Shield test based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests (NCD 210.3). The test is covered once every three years for eligible Medicare beneficiaries.

“The commercial launch of the Shield test and Medicare coverage make it possible for millions of eligible individuals to access a convenient, more pleasant way to stay up to date with colorectal cancer screening and detect the disease early, when it is more easily treated,” said AmirAli Talasaz, Guardant Health co-CEO. “From day one, Shield will be covered for more than 45 million Medicare beneficiaries, including many who are non-compliant with colonoscopy. This represents both a major step forward in the fight against colorectal cancer and a significant opportunity for Guardant Health. We also look forward to the process of getting Shield included in clinical guidelines to support private payer coverage, which will enable even broader and more equitable access.”

Commercial insurance coverage for patients eligible for CRC screening will continue to expand pending future review and inclusion in guidelines by the American Cancer Society and the U.S. Preventive Services Task Force (USPSTF).

The Shield test received FDA approval as a primary non-invasive option for CRC screening in average-risk adults age 45 and older. The FDA approval was based on results of ECLIPSE, a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study, published in The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.^1,2

Screening for CRC is only effective if the test is completed. Over the last two years, among more than 20,000 Shield tests ordered by providers, there was greater than 90% adherence by patients to their provider’s order for CRC screening, a much higher rate than the 28-71% adherence to colonoscopy and stool-based testing.^2,3 Further, a randomized study from Kaiser Permanente demonstrated that when Shield blood testing was offered as an additional choice to standard screening options of stool testing and colonoscopy, 3 times more people were screened.⁴

In addition, a health outcome model (CAN-SCREEN) evaluating 1000 individuals age 45 - 75 years and at average risk of colorectal cancer demonstrates how combining test performance and high patient adherence through blood-based screening can optimize CRC-related health outcomes. Shield outperforms two guideline-recommended stool-based tests, fecal immunochemical test (FIT) and the multi-target stool DNA (mtsDNA) test when considering life years gained (214 vs. 157 and 199) and CRC cases averted (27 vs. 16 and 22). Shield also prevents more deaths from CRC (13 vs. 7 and 11).⁵

“The idea of introducing a blood test that can screen for colorectal cancer has been a dream of mine for decades,” said Andrew Spiegel, Chief Executive Officer of the Global Colon Cancer Association. “And that’s because I’ve seen the toll that colorectal cancer takes on the lives of those it impacts – especially when caught late. Having a test now in our toolbox that is so simple and straightforward to do will hopefully eliminate any and all excuses for skipping screening and help us finally bring our country’s screening rates to where they need to be.”

Healthcare providers can have patients complete a Shield test with a simple blood draw during a routine office visit, with test results available approximately two weeks after the sample is received at the Guardant Health lab. For complete product information about the Shield blood test for CRC screening, including full safety information, visit ShieldCancerScreen.com.

About Shield

Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

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.

References

1. Chung DC, Gray DM, Singh H et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. Mar 2024.
2. Guardant Health MCGP May 23, 2024. Sponsor Executive Summary available at fda.gov
3. Raymond et al. Am J Gastro. Oct 2023.
4. Coronado, et al. Gut. Jan 2024.
5. Forbes et al. Journal of Medical Economics. 2024.

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