Guardant Health to present real-world data supporting performance of Shield™ blood test for colorectal cancer screening at 2024 Digestive Disease Week
Guardant Health (Nasdaq: GH) will present real-world data supporting the performance of its Shield™ blood test for colorectal cancer (CRC) screening at the 2024 Digestive Disease Week (DDW) in Washington, DC. The Shield test aims to increase CRC screening rates by offering a more convenient and less unpleasant method compared to traditional options. Presentations will include data showing improved screening rates and early detection of CRC. Initial results from the ECLIPSE study, validating Shield’s performance, were unveiled at the 2023 DDW, leading to a premarket approval (PMA) application to the FDA. An FDA Advisory Panel is set to review this application on May 23, 2024.
- Real-world data supports the performance of the Shield™ test for CRC screening.
- The Shield test offers a more convenient and less unpleasant screening method.
- Presentations at DDW will highlight improved CRC screening rates and early detection.
- Initial ECLIPSE study results validated the Shield test's performance.
- PMA application for Shield submitted to the FDA based on ECLIPSE study data.
- Full study results published in the March 2024 issue of The New England Journal of Medicine.
- FDA Advisory Panel review scheduled for May 23, 2024.
- No concrete financial data or immediate revenue impact presented.
- FDA approval is still pending, creating uncertainty.
- Potential delays or negative outcomes from the upcoming FDA Advisory Panel review could impact stock performance.
- Reliance on the success of the Shield test could pose risks if the test does not perform as expected in broader applications.
“One in three eligible American adults have not been screened for CRC, in part because the currently available methods are unpleasant or inconvenient,” said AmirAli Talasaz, co-CEO of Guardant Health. “The data we will share at DDW underscores the important role that our Shield blood test can have in both improving screening rates and in detecting more colorectal cancer at an early stage, when it is most treatable. We look forward to sharing this important data at DDW.”
Guardant Health 2024 DDW Poster Presentations
Abstract |
Session |
Title |
May 20, 2024, 12:30 – 1:30 p.m. ET |
||
# Mo1026 |
Poster Session: 8000 |
Integration of a blood-based colorectal cancer screening test into routine radiology imaging visits improves overall screening rates |
# Mo1196 |
Poster Session: 8055 |
New screening tests, same challenge: an early look at colonoscopic follow-up after abnormal blood-based colorectal cancer screening results in a real world setting |
Guardant Health unveiled initial results from the ECLIPSE study validating the performance of the Shield test at the 2023 DDW meeting. The data served as the basis for Guardant Health’s submission of a premarket approval (PMA) application to the FDA, and the full study results have since been published in the March 2024 issue of The New England Journal of Medicine. An FDA Advisory Panel is scheduled to review the PMA application on May 23.
The full abstracts for Guardant Health and a list of all abstracts being presented at the meeting will be available at the DDW website.
For information and updates from the meeting, follow Guardant Health on LinkedIn, X (Twitter) and Facebook.
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 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 helping doctors select the best treatment 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240516838593/en/
Investor Contact:
Zarak Khurshid
investors@guardanthealth.com
Media Contact:
Mike Weist
press@guardanthealth.com
+1 650-647-3643
Source: Guardant Health, Inc.
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