A U.S. Food and Drug Administration advisory panel has recommended approval of Galleri, a multi-cancer early detection test developed by U.S. cancer diagnostics company Grail. The move brings the test a step closer to premarket approval (PMA) and is expected to benefit Samsung Electronics (005930) and Samsung C&T (028260), which together invested $110 million in the company.
According to the pharmaceutical and biotech industry on the 27th, the Molecular and Clinical Genetics Devices Panel under the FDA's Medical Devices Advisory Committee voted on the 23rd on Galleri's safety, effectiveness and benefit-risk profile. The panel voted unanimously in favor of safety, 6-4 in favor of effectiveness and 7-2 in favor of the benefit-risk profile, with one abstention.
Galleri analyzes DNA methylation patterns common across various cancers to detect signs of the disease before symptoms appear. DNA methylation refers to a unique chemical pattern that emerges when cancer cells develop, in which chemical switches attach to DNA molecules. The test is designed to narrow the scope of follow-up imaging and biopsies. It can also detect cancers that lack established routine screening protocols, including pancreatic, ovarian and esophageal cancer. Panel members concluded that while the test does not fully replace existing cancer screening, it offers significant benefits when used as an additional test.
The FDA typically follows its advisory panels' recommendations, even though the votes are not legally binding. Grail applied for PMA for Galleri in January, and the FDA is expected to decide on final approval within months. According to Grail, no multi-cancer early detection test currently has full FDA marketing authorization in the United States. Final FDA approval would establish Galleri as the first blood-based multi-cancer screening test in the country.
With the regulatory path clearing, Samsung Electronics and Samsung C&T are also expected to benefit. The two companies invested $110 million in Grail in October last year. Samsung Electronics plans to link Grail's technology and its accumulated genetic data on early cancer detection to the Galaxy device ecosystem, including Samsung Health users, to offer health management services. Samsung C&T has secured exclusive rights to distribute the Galleri test in South Korea and is reviewing plans to expand the business to Japan and Singapore.
Galleri is currently authorized as a laboratory developed test (LDT), limiting its use to laboratories. As a result, consumers who want the test must pay the full cost of $940 themselves. If PMA is granted, the test could become eligible for discussions on coverage by public insurers such as Medicare and by private insurers, as well as for inclusion in screening guidelines, potentially expanding the market significantly. Galleri generated $136.8 million in U.S. revenue last year.
