Guardant Health submits final module of Shield PMA application to FDA

Guardant Health announced that it has submitted to the FDA the final module of its premarket approval, or PMA, application for Shield, Guardant Health’s blood test to screen for colorectal cancer, or CRC. The submission is comprised of 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. Preliminary results from the study showed that the Shield test achieved 83% sensitivity for the detection of colorectal cancer with specificity of 90%.