Sept 23 (Reuters) – A panel of outside experts advising the US FDA backed the safety of Grail’s blood-based cancer detection test, Galleri, on Wednesday, but was divided on the evidence supporting its effectiveness.
While all the 10 panel members unanimously backed Galleri’s safety, support for its effectiveness was narrower with a 6-4 vote in favor. Members also voted 7-2 that the test’s benefits outweigh its risks, with one abstention.
The US Food and Drug Administration is not bound by its panel’s votes but weighs them heavily when making final decisions. A final decision on whether Galleri can be sold nationwide is expected in the coming months.
Galleri is a blood test that looks for signs of cancer in a single blood draw. It is designed for adults aged 50 and older, and can screen for many types of cancer at once, something no other approved test currently does in the United States.
Grail tested the device in two large studies — one in the US and another in Britain. The US study found the test detected 35% of cancers within 12 months and rarely gave false alarms, with a specificity of 99.85%. The British trial also showed similar results.
(Reporting by Padmanabhan Ananthan and Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar)
