A multi-cancer early detection test named Galleri from the health-care company GRAIL received a favorable vote from the Molecular and Clinical Genetics Devices Panel of the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee. The Committee voted for approval of the premarket approval application for the early detection test. The news was announced in a statement earlier this week.
In three separate votes, the 10 voting members of the Committee considered the test’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 Committee voted seven to two with one abstention that the benefits of the multi-cancer early detection test outweigh its risks, unanimously in support of the test's safety, and six to four in support of the test's effectiveness.
The qualitative, next-generation sequencing (NGS)-based in vitro diagnostic test is intended to detect cancer-specific methylation patterns in cell-free DNA isolated from peripheral whole blood. The test is prescription-only and intended for screening for the early detection of multiple types of cancer in adults aged 50 years or older. The test is also intended to predict where a detected cancer signal may have originated in the body and should be followed by a diagnostic workup by a qualified health-care professional.
The multi-cancer early detection test is supported by large interventional and randomized controlled studies in intended-use populations, including FDA-approved Investigational Device Exemption studies, namely PATHFINDER 2 in North America and the landmark NHS-Galleri trial in England. Results of both trials were published recently in Nature Medicine, with related papers published in The New England Journal of Medicine.
In clinical studies, the multi-cancer early detection test has detected approximately four to seven times more cancers compared to standard of care alone. Further, most test-detected cancers were found at earlier stages when treatment with curative intent may be possible, while maintaining a low false-positive rate and high cancer signal origin prediction accuracy.
The FDA designated Galleri as a Breakthrough Device in 2018.
The FDA convenes advisory committees to obtain independent expert advice. The agency is not bound by the Committee’s recommendations, although it takes them into consideration when making final regulatory decisions. The FDA is expected to make a final decision on the pre-market approval application in the coming months.
