Guardant Health Gets FDA Nod on Colorectal Cancer Blood Test

Core Insights - Guardant Health's Shield blood test is the first FDA-approved primary screening option for colorectal cancer, specifically for adults aged 45 and older with average risk [1][3]. - The Shield test demonstrated 83% sensitivity in detecting colorectal cancer and 90% specificity for advanced neoplasia in clinical studies [2]. - Following the FDA approval, Guardant Health's shares increased by 3% to $34.00, marking a 25% rise in the stock price for the year [4][5]. Company Impact - The FDA approval is viewed as a significant victory for patients and a milestone in Guardant Health's mission to enhance cancer detection through data [4]. - The Shield test is expected to improve colorectal cancer screening rates, facilitating earlier detection when treatment is more effective [4].