Chatanaka Miyo K, Yousef George M, Diamandis Eleftherios P
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Laboratory Medicine Program, 7989 University Health Network , Toronto, ON, Canada.
Clin Chem Lab Med. 2024 Sep 23;63(3):499-506. doi: 10.1515/cclm-2024-1013. Print 2025 Feb 25.
The biotechnology company Grail developed a non-invasive blood test (Galleri test) which is claimed to detect 50 types of cancer at early and potentially curable stages. The initially promising results from prospective studies, and the anticipated financial success of Grail led the sequencing giant Illumina to purchase Grail for $8 billion (2021). Following this event, Grail collaborated with the UK National Health System to further clarify the test's capability, in a 3-year prospective trial, along with the standard of care. The UK-NHS announced that the trial will provide a clearer understanding of the efficacy of the Galleri test within the NHS framework. If the test does not perform as expected, valuable insights will still be gained to guide future research aimed at enhancing cancer screening. We previously expressed concerns about the sensitivity and specificity of the Galleri test. In this opinion paper, we revisit the hyped technology, and we provide new suggestions on the use of this test.
生物技术公司Grail开发了一种非侵入性血液检测(Galleri检测),据称该检测能够在癌症早期和潜在可治愈阶段检测出50种癌症。前瞻性研究最初取得的令人鼓舞的结果,以及Grail预期的财务成功,促使测序巨头Illumina在2021年以80亿美元收购了Grail。此次收购后,Grail与英国国家医疗服务体系合作,在一项为期3年的前瞻性试验中,结合标准治疗方法,进一步明确该检测的能力。英国国家医疗服务体系宣布,该试验将更清楚地了解Galleri检测在国家医疗服务体系框架内的疗效。如果检测结果不如预期,仍将获得宝贵的见解,以指导未来旨在加强癌症筛查的研究。我们此前曾对Galleri检测的敏感性和特异性表示担忧。在这篇观点文章中,我们重新审视这项被炒作的技术,并就该检测的使用提出新的建议。