SUNNYVALE, September 23 — An advisory panel of the U.S. Food and Drug Administration has voted in favour of approving GRAIL, Inc.’s Galleri multi-cancer early detection test, a recommendation that moves the blood-based screening tool one step closer to a final agency decision. The Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee cast three separate votes on Galleri’s safety, effectiveness and overall benefit-risk profile for screening for the early detection of multiple types of cancer in adults aged 50 years and older.
The panel voted seven to two, with one abstention, that the benefits of Galleri outweigh its risks. It voted unanimously in support of the test’s safety, and six to four in support of its effectiveness.
What the test is designed to do
Galleri is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening today. When a cancer signal is detected, the test is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. GRAIL is careful to stress that Galleri is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings.
That distinction matters for patients, who should continue with mammograms, colonoscopies and other established tests as advised by their physicians. The company, based in Sunnyvale, California, describes itself as a healthcare company whose mission is to detect cancer early when it can be cured.
The evidence behind the vote
Josh Ofman, MD, MSHS, chief executive officer at GRAIL, said the Galleri test was developed to improve the effectiveness and efficiency of the 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 when it still may be possible for a patient to receive treatment with curative intent.
Ofman said the vote reinforces the strength of Galleri’s clinical evidence, and that GRAIL believes the panel’s recommendations reaffirm a high evidence bar the company has set for a multi-cancer early detection test. He also said GRAIL was heartened by the more than 200 physicians, nurses, professional societies, patients, patient advocates and others who shared their support for Galleri through the written public docket and open comment period during the panel.
According to GRAIL, Galleri is the only MCED test supported by large interventional and randomized controlled studies in intended-use populations, including FDA-approved Investigational Device Exemption studies — PATHFINDER 2 in North America and the NHS-Galleri trial in England. The company said its clinical development program is one of the largest in cancer.
What happens next
The advisory committee vote is a recommendation only. The FDA makes the final decision on the Premarket Approval application, and GRAIL said it is committed to working with the agency as it completes its review. The company describes the submission as the first PMA application for a multi-cancer early detection test.
For now, the encouraging part is that a rigorous, evidence-based review process is doing exactly what it should — weighing benefits against risks before any test reaches the wider public. Patients considering cancer screening should talk to their doctor about what is appropriate for them. Consult your doctor for medical advice.
