The equity financing will support the expansion of multi-cancer early detection testing into Asian markets and fund US regulatory efforts.
GRAIL Inc has closed a $110 million equity financing agreement with Samsung affiliates to accelerate US regulatory approval and reimbursement for its Galleri multi-cancer early detection test.
The funding will support the clinical test’s international expansion, with all initial specimen testing continuing to be performed at GRAIL’s CLIA-certified, and CAP-accredited clinical laboratory in Research Triangle Park, North Carolina.
The Galleri test is designed to screen for more than 50 cancer types through a single blood draw.
“This investment from the Samsung entities further strengthens our balance sheet and extends our cash runway as we advance key priorities, including securing regulatory approval and reimbursement for Galleri in the United States and expanding access to multi-cancer early detection internationally,” says Aaron Freidin, chief financial officer of GRAIL, in a release.
Expansion into Asian Markets
As part of the agreement, GRAIL and Samsung C&T Corporation intend to collaborate on the commercialization of the Galleri test in South Korea. The partnership may eventually expand to include other Asian markets, such as Japan and Singapore, subject to regulatory approvals and other conditions.
Despite the planned international expansion, the company confirmed that initial testing for these markets will continue to be performed at its clinical laboratory in Research Triangle Park, North Carolina. The laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 and accredited by the College of American Pathologists.
“GRAIL is at a pivotal moment in its mission to transform early cancer detection. This investment in GRAIL, together with the strategic business collaboration, represents a significant milestone in advancing Samsung C&T’s vision expanding access to cancer early detection,” says Jaywoo Kim, executive vice president of life science business at Samsung C&T, in a release.
Clinical Evidence and Regulatory Status
The Galleri test has not been cleared or approved by the Food and Drug Administration. It is currently offered as a laboratory-developed test in a clinical laboratory regulated under CLIA to perform high-complexity testing.
The test is backed by clinical studies involving more than 380,000 participants, including the NHS-Galleri trial. According to the company, the test can predict the cancer signal of origin with greater than 90% accuracy. It is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older, and is intended to be used in addition to routine cancer screening tests, such as mammography, colonoscopy, and lung cancer screening.
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