FDA Advisory Panel Review of Guardant Health’s Shield™ Blood Test to Screen for Colorectal Cancer to Be Held on May 23

Rhea-AI Summary

Guardant Health, Inc. (Nasdaq: GH) is set to have the FDA Advisory Panel review its Shield™ blood test for colorectal cancer screening on May 23, 2024. The company aims to present clinical data from its ECLIPSE study, highlighting the potential of the Shield test to provide a more convenient and effective screening option for early detection of colorectal cancer, increasing treatment opportunities.

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration Medical Devices Advisory Committee is scheduled to review the premarket approval (PMA) application for the company’s Shield™ blood test for colorectal cancer (CRC) screening on Thursday, May 23, 2024.

“We look forward to discussing with the FDA Advisory Committee and its panel of experts the clinical data from our ECLIPSE study and the potential for the Shield blood test to overcome the barriers of current screening methods and offer a new, more convenient screening option that will detect colorectal cancer in the early stages, when it is most treatable,” said AmirAli Talasaz, co-CEO of Guardant Health.

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240421042636/en/

Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Michael Weist

press@guardanthealth.com

+1 317 371 0035

Source: Guardant Health, Inc.

FAQ

When is the FDA Advisory Panel review of Guardant Health's Shield™ blood test for colorectal cancer screening scheduled?

The FDA Advisory Panel review is set to take place on May 23, 2024.

What is the purpose of the FDA Advisory Panel review for Guardant Health?

The review will evaluate the premarket approval (PMA) application for Guardant Health's Shield™ blood test for colorectal cancer screening.

What study data will Guardant Health present during the FDA Advisory Panel review?

Guardant Health will present clinical data from its ECLIPSE study during the review.

Who is the co-CEO of Guardant Health and what are their comments on the Shield™ blood test?

AmirAli Talasaz is the co-CEO of Guardant Health. He mentioned that the Shield blood test could offer a more convenient and effective screening option for early detection of colorectal cancer.