FDA advisers back Grail’s Galleri cancer blood test

The FDA’s molecular and clinical genetics advisory panel backed Grail’s Galleri blood test for detecting multiple cancers. Panel members said the test should not replace cancer screening recommended in current medical guidelines, including tests for breast, cervical, colorectal and lung cancer. Galleri uses a single blood draw to look for cancer signals and may detect cancers that have no existing screening methods.

Panel members also raised concerns about limited data on how reliably the test detects some cancer types. The test failed to meet the primary endpoint in the NHS-Galleri trial. Grail said its data showed a shift toward detection signals at earlier cancer stages, and said Galleri detected about four to seven times more cancers compared with standard of care alone.