GRAIL, a healthcare company headquartered in Sunnyvale, California, announced that it has reached a significant milestone toward commercializing its Galleri multi-cancer early detection test. The company received a favorable vote from an FDA advisory committee for the device’s premarket approval.
“The Galleri test was developed to improve the effectiveness and efficiency of our national cancer screening program by adding multi-cancer early detection to recommended screening — helping find more cancers safely, when they may be easier and less costly to treat, and it still may be possible for a patient to receive treatment with curative intent,” Dr. Josh Ofman, GRAIL’s CEO, said in a statement.
The Galleri test is designed to detect certain biochemical patterns shared by many types of cancer before symptoms appear. It’s designed to accurately predict the origins of cancer signals to help guide diagnostic evaluation during guideline-recommended screenings. Members of the Molecular and Clinical Genetics Devices Panel of the FDA’s Medical Devices Advisory Committee considered Galleri to be safe, effective and to have more benefits than risks when used to screen for early cancer detection in adults aged 50 years and older.
“Today’s vote reinforces the strength of Galleri’s clinical evidence. We believe the panel’s recommendations reaffirm a high evidence bar that GRAIL has set for a multi-cancer early detection test,” Ofman continued. “GRAIL is committed to working with the FDA as it completes its review of Galleri, the first PMA submission for a multi-cancer early detection test.”
