The Unholy Grail of cancer screening: or is it just about the Benjamins?

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Clinical chemistry and laboratory medicine Pub Date : 2024-09-23 DOI:10.1515/cclm-2024-1013
Miyo K Chatanaka, George M Yousef, Eleftherios P Diamandis
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Abstract

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. At the end of the first year, UK-NHS announced that they will suspend the trial due to unsatisfactory clinical performance and until they analyze the data for the first year (which already enrolled 140,000 participants). Legal and financial issues between the interested parties are currently in flux. 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.

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癌症筛查的圣杯:还是仅仅为了本杰明?
生物技术公司 Grail 开发了一种无创血液检验(Galleri 检验),据称可以在早期和可能治愈的阶段检测出 50 种癌症。前瞻性研究的初步结果令人鼓舞,加上 Grail 预期的财务成功,测序巨头 Illumina 公司以 80 亿美元(2021 年)的价格收购了 Grail 公司。在此之后,Grail 与英国国家卫生系统合作,在为期 3 年的前瞻性试验中进一步明确了该测试的能力,以及标准治疗方法。在第一年结束时,英国国家卫生系统宣布,由于临床表现不尽如人意,他们将停止试验,直到对第一年的数据进行分析为止(第一年已经有 14 万人参与试验)。目前,相关各方之间的法律和财务问题仍在争议之中。圣杯事件让人联想到耗资数十亿美元的Theranos丑闻,该丑闻导致一些人锒铛入狱,公司也因此解散。我们曾对盖勒瑞检测的灵敏度和特异性表示过担忧。在本《视角》中,我们将重新审视这项被炒得沸沸扬扬的技术,并就如何使用这项检测提出新的建议。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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