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A significant setback for early cancer detection has emerged as Grail, a U.S. Biotech company backed by Samsung, announced disappointing results from a large-scale clinical trial of its “Gallery” test in the United Kingdom. The trial, designed to assess the test’s ability to detect cancer at earlier stages, failed to meet its primary endpoint, sending the company’s stock price plummeting over 50% in a single day. The outcome casts a shadow over Grail’s plans to gain regulatory approval and widespread insurance coverage for the potentially groundbreaking blood test.
Grail’s Gallery test analyzes blood samples for minute traces of cancer DNA, aiming to detect over 50 different types of cancer in their early stages – even before symptoms appear. While the test has been commercially available in the United States since 2021, with nearly 500,000 tests administered to date, including 185,000 in the past year, it currently lacks approval from the U.S. Food and Drug Administration (FDA) and is rarely covered by insurance. The promise of broader access hinged on demonstrating the test’s clinical and economic value, a goal now complicated by the UK trial results.
The primary endpoint of the UK trial focused on assessing the test’s impact on the proportion of patients diagnosed with stage 3 or 4 cancer. Grail had hoped to demonstrate that early detection through Gallery would shift diagnoses towards earlier stages (1 and 2), reducing the prevalence of late-stage cancers. However, in a statement released after market close, the company acknowledged that this primary endpoint was “not observed.” Despite this, Grail representatives suggested during an investor call that the test may still have a modest effect on advancing the timing of cancer diagnoses, with some positive trends observed in secondary endpoints such as a potential reduction in stage 4 diagnoses and an increase in stage 3 diagnoses.
The trial involved 142,000 participants aged 50 to 77. The disappointing results come at a critical juncture for Grail, as the company had anticipated benefiting from a recent U.S. Federal spending package that includes a provision allowing Medicare, the public health insurance program for seniors and individuals with disabilities, to cover cancer diagnostic tests. This provision, signed into law by President Trump in February, raised hopes that Gallery could develop into a covered benefit. However, the UK trial failure has significantly dampened those expectations.
Samsung’s Investment and Future Implications
Grail’s stock price reflected the market’s reaction to the news, closing down 50.55% at $50.21 on February 20th, 2026, and continuing to fall in after-hours trading, dropping below the $50 mark. The company has significant ties to Samsung, with Samsung Electronics and Samsung C&T investing $110 million (approximately 159 billion Korean won) in Grail in October 2025. At the time, Samsung C&T secured exclusive rights to distribute Gallery in South Korea, with plans to expand collaboration into Singapore and Japan. Samsung Electronics also expressed interest in integrating Grail’s genomic data with its Samsung Health platform to offer innovative health management experiences to users. Source: Nate News
The failed trial raises questions about the future of multi-cancer early detection tests and the viability of Grail’s business model. While the company maintains that Gallery shows promise, the lack of a clear signal in the primary endpoint will likely require further research and refinement. The path to regulatory approval and widespread adoption now appears more challenging, and the impact on Samsung’s investment remains to be seen.
The development of effective early cancer detection methods remains a critical area of medical research. The potential to identify cancers at earlier, more treatable stages could significantly improve patient outcomes and reduce healthcare costs. However, as the Grail experience demonstrates, translating promising scientific concepts into clinically validated and commercially successful products is a complex and often unpredictable process.
Disclaimer: This article provides informational content about medical research and is not intended to be a substitute for professional medical advice. Always consult with a qualified healthcare provider for diagnosis and treatment of any medical condition.
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