GH - Blood-Based Colorectal Cancer CRC Screening Market Likely to Benefit From FDA's Panel Surprise Advisory Possibility: Analyst | Benzinga
Tuesday, Guardant Health Inc (NASDAQ: GH) announced that the FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for its Shield blood test to screen for colorectal cancer on March 28, 2024.
Guardant Health submitted the final module of its PMA for Shield on March 10, 2023.
The submission includes data from the ECLIPSE study, an over 20,000-patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults.
William Blair suggests that the recent news will likely favor ...