Guardant Health announces tentative date of FDA panel review of Shield test

Guardant Health announced that the U.S. Food and Drug Administration’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application for the company’s Shield blood test to screen for colorectal cancer on March 28, 2024. The date and details of the meeting are subject to confirmation by the FDA and publication in the Federal Register. Guardant Health submitted the final module of its PMA for Shield on March 10, 2023. The submission includes data from the company’s positive ECLIPSE study, an over 20,000-patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults. “We welcome the opportunity to engage in a discussion with key opinion leaders about our study results and the power of Shield in closing the screening gap once FDA approved,” said AmirAli Talasaz, co-CEO of Guardant Health. “The proposed timing of the meeting is in line with our expectation to complete the PMA process and launch Shield IVD in 2024.”