Guardant Health Stock Trading Temporarily Halted; FDA Panel to Assess Premarket Approval Application for Shield Blood Test for Colorectal Cancer Screening

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05/23/2024 - 07:05 AM

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Nasdaq has temporarily halted trading of the company's stock.

The Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee will meet today to review the premarket approval (PMA) application for Shield^TM, Guardant Health’s blood test to screen for colorectal cancer in average-risk adults.

The panel meeting is scheduled to begin at 9:30 a.m. ET.

FDA advisory committees provide independent expert advice and non-binding recommendations to the FDA on certain products to help the agency make sound decisions based on the available science.

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.