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Guardant Health Announces Clinical Result Update for Shield Blood-Based Colorectal Cancer Screening Test

via Business Wire
  • Latest algorithm (Shield V2) has sensitivity of 84% for colorectal cancer with specificity of 90%, with stage I sensitivity of 62%
  • Performance of the Shield algorithm was validated in expanded clinical cohort derived from landmark ECLIPSE study

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a positive clinical readout update assessing the performance of the latest colorectal cancer (CRC) screening algorithm (V2) for its Shield™ blood test. The study met all primary endpoints and the sensitivity of this new screening algorithm for detecting CRC was 84% with 90% specificity. Sensitivity for detection of stage I CRC was 62%.

“We are pleased with the performance of the new algorithm in detecting stage I CRCs. Today’s update shows yet again that Shield delivers best-in-class performance,” said AmirAli Talasaz, Guardant Health co-CEO. “We will continue to leverage our first mover advantage, rapidly growing database and innovation engine to push Shield to higher levels of performance over time.”

The clinical validation of the algorithm was conducted on an expanded cohort of subjects enrolled in the landmark ECLIPSE study. ECLIPSE is a 20,000+ person registrational study evaluating the performance of Shield for detecting CRC in average-risk adults that was published in The New England Journal of Medicine. Sensitivity for early-stage CRC was 62% for stage I and 100% for stage II. Sensitivity was 96% for stage III and 100% for stage IV. Sensitivity in detecting advanced adenomas was 13%.

The National Comprehensive Cancer Network (NCCN) recently updated its CRC Screening Guidelines to add Shield as the first blood test that is FDA approved for primary screening of CRC. Shield has also received numerous awards recognizing its innovation and power to change lives, including Fast Company’s World Changing Ideas, TIME’s list of the Best Inventions of 2024 and was selected as a Grand Award Winner in Popular Science’s Best of What’s New 2024.

Beyond CRC screening, Guardant Health has a pipeline of activities around the Shield platform, including the Shield multi-cancer detection (MCD) test which was recently granted Breakthrough Device Designation by the FDA and included in the National Cancer Institute’s Vanguard study.

Shield is the first and only blood test that has received full FDA approval as a primary screening option for CRC in average-risk adults aged 45 and older and can be ordered by any prescribing healthcare provider. 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.

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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