The Galleri® test: The first clinically-validated MCED test
Galleri®测试：第一个经过临床验证的 MCED 测试
The Galleri test can detect a signal shared by over 50 types of cancer with 99.5% specificity and predict the cancer signal origin with high accuracy to help guide next steps. This means that in approximately 200 people tested, only 1 person would be expected to receive a false positive result. In study participants, when the Galleri test detected cancer the first or second Cancer Signal Origin prediction was correct 88% of the time when cancer was found after diagnostic evaluation.1
Galleri 测试可以检测到超过 50 种癌症共享的信号，具有 99.5%的特异性，并能高精度预测癌症信号的来源，以帮助指导下一步的措施。这意味着在大约 200 人接受测试时，只有 1 人有望得到错误的阳性结果。在研究参与者中，当 Galleri 测试在诊断评估后检测到癌症时，第一或第二次癌症信号来源的预测正确率为 88%。
Galleri 测试的性能得到了广泛的临床研究支持
The support and validation of GRAIL’s science is critical, that is why we have built what we believe to be the largest clinical trial program ever pursued in genomic medicine. We are collaborating with leading health systems, academic medical centers, and industry partners around the world to help make early detection accessible to as many people as possible.
GRAIL 的科学支持和验证至关重要，这就是为什么我们建立了我们认为是迄今为止在基因医学领域追求的最大临床试验计划。我们与全球领先的医疗系统、学术医疗中心和行业合作伙伴合作，帮助尽可能多的人获得早期检测。
Galleri 测试是常规筛查的补充
The Galleri test is intended to complement routine single cancer screenings for more comprehensive early cancer detection. Routine screenings are recommended for certain patients for breast, cervical, colorectal, lung and prostate cancers.2
Galleri 测试旨在为更全面的早期癌症检测补充常规单一癌症筛查。对于乳腺癌、宫颈癌、结直肠癌、肺癌和前列腺癌，建议对特定患者进行常规筛查。
Only screening for a single cancer does not effectively address the high prevalence of cancer given the probability of diagnosis for a specific cancer is uncertain, and the occurrence of individual cancers is relatively low. One in two men and one in three women are diagnosed with some form of cancer in America in their lifetime.
仅仅筛查一种癌症并不能有效应对癌症的高发病率，因为特定癌症的诊断概率是不确定的，而个体癌症的发生率相对较低。在美国，每两个男性中就有一个人在一生中被诊断出某种形式的癌症，而每三个女性中就有一个人被诊断出某种形式的癌症。
重要的安全信息
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Galleri 测试建议用于具有较高癌症风险的成年人，例如 50 岁或以上的人。Galleri 测试不能检测所有癌症，应与医疗保健提供者推荐的常规癌症筛查测试一起使用。Galleri 旨在检测癌症信号并预测癌症信号在身体的位置。不建议孕妇、21 岁以下的人或正在接受积极癌症治疗的人使用 Galleri。
Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer.
结果应该在医疗历史、临床体征和症状的背景下由医疗提供者进行解读。 "未检测到癌症信号" 的测试结果并不能排除癌症。 "检测到癌症信号" 的测试结果需要通过医学确认的程序（例如影像学）进行确诊。
If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.
如果进一步的测试未确认癌症，可能意味着没有癌症存在或者测试不足以检测到癌症，包括因为癌症位于身体的其他部位。假阳性（在没有癌症存在时检测到癌症信号）和假阴性（在有癌症存在时未检测到癌症信号）的测试结果确实会发生。仅限处方使用。
实验/测试信息
GRAIL 的临床实验室符合 1988 年临床实验室改进修正案（CLIA）的认证，并获得美国病理学家学院的认可。Galleri 测试是由 GRAIL 开发的，并确定了其性能特征。Galleri 测试尚未获得食品和药物管理局的批准或认可。GRAIL 的临床实验室受 CLIA 监管，可进行高复杂度测试。Galleri 测试旨在用于临床目的。
1. Schrag D, McDonnall CH, Naduld L, et al. PATHFINDER: A Prospective Study of a Multi- Cancer Early Detection Blood Test. Presentation at European Society of Medical Oncology (ESMO) Congress September 9-13, 2022; Paris, France
2022 年 9 月 9 日至 13 日，法国巴黎举行的欧洲医学肿瘤学会（ESMO）大会上，Schrag D、McDonnall CH、Naduld L 等人进行了一项名为 PATHFINDER 的多癌症早期检测血液测试的前瞻性研究的报告。
2. United States Preventive Services Task Force (USPSTF)
美国预防服务工作组（USPSTF）
