PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that results from the ECLIPSE study showing the effectiveness of its ShieldTM blood test for detecting colorectal cancer (CRC) in average-risk adults will be published in the March 14 issue of The New England Journal of Medicine..

加利福尼亚州帕洛阿尔托（商业新闻短讯）--领先的精准肿瘤学公司Guardant Health，Inc.（纳斯达克：GH）今天宣布，ECLIPSE研究的结果显示其ShieldTM血液检测在平均风险成年人中检测结直肠癌（CRC）的有效性将发表在3月14日的《新英格兰医学杂志》上。

“Over 50 million eligible Americans do not get recommended screenings for colorectal cancer, partly because current screening methods are inconvenient or unpleasant,” said AmirAli Talasaz, Guardant Health co-CEO. “We believe the publication of the ECLIPSE study in The New England Journal of Medicine, one of the world’s leading medical journals, is an endorsement of the quality of our clinical data and the potential value of the Shield test.

Guardant Health联合首席执行官阿米拉利·塔拉萨兹（AmiriTalasaz）表示：“超过5000万符合条件的美国人没有得到推荐的大肠癌筛查，部分原因是目前的筛查方法不方便或令人不快。”“我们认为，在世界领先的医学期刊之一《新英格兰医学杂志》上发表的ECLIPSE研究，是对我们临床数据质量和Shield测试潜在价值的认可。

We are confident that offering an accurate blood test has the potential to significantly reduce preventable colorectal cancer deaths.”.

我们相信，提供准确的血液检测有可能显着减少可预防的结直肠癌死亡。”

One of the largest studies of its kind, ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode) is a 20,000+-patient registrational study to evaluate the performance of Shield compared to a screening colonoscopy. The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA)..

同类研究中规模最大的研究之一，ECLIPSE（在平均患者筛查事件中评估ctDNA月球检测）是一项20000多名患者登记研究，旨在评估Shield与筛查结肠镜检查相比的性能。Shield测试从肿瘤脱落的DNA（称为循环肿瘤DNA（ctDNA））中检测血液中的结直肠癌信号。

Highlights of the study results to be published in The New England Journal of Medicine* show that Shield demonstrated:

将在《新英格兰医学杂志》上发表的研究结果摘要*表明，Shield证明了：

83% sensitivity in detecting individuals with CRC

检测CRC患者的敏感性为83%

88% sensitivity in detecting pathology-confirmed Stages I-III

88%的敏感性检测病理证实的I-III期

Sensitivity by stage of:

按阶段划分的灵敏度：

65% for pathology-confirmed Stage I; 55% for clinical Stage I

病理证实的I期为65%；临床I期55%

100% for Stage II

第二阶段100%

100% for Stage III

第三阶段100%

100% for Stage IV

第四阶段100%

These results are on par with the performance of other guideline-recommended non-invasive screening modalities, where overall sensitivity in detecting colorectal cancer ranges from 74% to 92%.1

这些结果与其他指南推荐的非侵入性筛查方式的表现相当，其中检测结直肠癌的总体敏感性在74%至92%之间

“More than 3 out of 4 Americans who die from colorectal cancer are not up to date with their recommended screening,2 highlighting the need for a more convenient and less invasive screening method that can overcome barriers associated with traditional options,” said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School.

麻省总医院胃肠病学家、哈佛医学院医学教授Daniel Chung博士说：“死于结直肠癌的美国人中，有四分之三以上的人没有达到他们推荐的筛查方法，2强调需要一种更方便、侵入性更小的筛查方法，以克服与传统选择相关的障碍。”

“The ECLIPSE study results published today support the use of a blood test as a screening option that could help overcome these barriers and improve CRC screening rates.'.

“今天公布的ECLIPSE研究结果支持使用血液检测作为筛查选择，可以帮助克服这些障碍并提高CRC筛查率。”

Publication of ECLIPSE follows Guardant Health’s submission of its premarket approval (PMA) application to the U. S. Food and Drug Administration (FDA) for Shield, which included key data points from the study. Since the launch of the lab-developed version of the Shield test in May 2022, it has been used by more than 20,000 people and more than 90% of patients who were prescribed the test in the real-world clinical setting completed it.

ECLIPSE发布之前，Guardant Health向美国食品和药物管理局（FDA）提交了上市前批准（PMA）申请，其中包括该研究的关键数据点。自2022年5月推出实验室开发的Shield测试版本以来，已有2万多人使用，超过90%的患者在现实世界的临床环境中完成了该测试。

One recent study showed that CRC screening rates tripled among adults who had declined prior CRC screening when they were offered Shield. The test’s sensitivity in detecting CRC, combined with this real-world adherence, suggests that Shield has the potential to detect more CRCs at a curable stage than traditional screening methods.3,4,5,6.

最近的一项研究表明，在接受过CRC筛查的成年人中，CRC筛查率增加了三倍。该测试在检测CRC方面的敏感性，加上这种现实世界的依从性，表明Shield有可能在可治愈阶段比传统筛查方法检测更多的CRC[3,4,5,6]。

“Colorectal cancer is highly treatable if caught in the early stages, yet more than 50 million people in the U.S. are still not completing their recommended screening with the methods available today,” said Chris Evans, president of the Colon Cancer Coalition. “This publication gets us one step closer to having an additional option to offer patients – one that is both convenient and accessible—and will help us close the screening gap.”.

结肠癌联盟主席克里斯·埃文斯（ChrisEvans）说：“如果在早期发现结直肠癌，那么结直肠癌是可以高度治疗的，但美国仍有5000多万人没有按照目前可用的方法完成推荐的筛查。”。“这份出版物使我们离为患者提供额外的选择又近了一步，这种选择既方便又容易获得，并将帮助我们缩小筛查差距。”

Colorectal cancer is the second-leading cause of cancer deaths in the U.S. The American Cancer Society estimates that more than 150,000 people will be diagnosed with CRC in 20247 and it is expected to become the leading cause of cancer-related deaths by 2030 in adults aged 20-49.8 More than 75% of people who die from CRC are not up to date with recommended screening,9 often due to the perception that current methods such as colonoscopy or stool-based tests are invasive, time-consuming and inconvenient.

结直肠癌是美国癌症死亡的第二大原因。美国癌症协会估计，到20247年，将有超过150000人被诊断出患有结直肠癌，预计到2030年，结直肠癌将成为20-49.8岁成年人癌症相关死亡的主要原因。超过75%的结直肠癌死亡者没有进行推荐的筛查，9通常是由于认为目前的方法，如结肠镜检查或粪便检查是侵入性的，耗时且不方便。

Early detection, however, is crucial. When colon cancer is found at an early stage before it has spread, the 5-year relative survival rate is 91%. If the cancer has spread to distant parts of the body, the 5-year survival rate is 13%..

然而，早期发现至关重要。当结肠癌在扩散之前的早期发现时，5年相对生存率为91%。如果癌症扩散到身体的远处，5年生存率为13%。

“The results of the study are a promising step toward developing more convenient tools to detect colorectal cancer early while it is more easily treated,” said corresponding author William M. Grady, MD, a gastroenterologist at Fred Hutchinson Cancer Center. “The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options.'.

通讯作者、弗雷德·哈钦森癌症中心胃肠病学家威廉·格雷迪医学博士说：“这项研究的结果是朝着开发更方便的早期检测结直肠癌的工具迈出的有希望的一步。”“这项检测结肠癌的准确率与用于早期发现癌症的粪便检测相似，可以为可能拒绝目前筛查选择的患者提供替代方案。”

About the ECLIPSE study

关于ECLIPSE研究

ECLIPSE is a prospective registrational study to evaluate the performance of Guardant Health’s blood test in detecting signs of CRC compared to a screening colonoscopy in average-risk adults between the ages of 45 and 84 from across the U.S. The ECLIPSE study included more than 200 clinical trial sites in rural and urban communities across 34 states.

ECLIPSE是一项前瞻性注册研究，旨在评估Guardant Health血液检测在检测CRC征象方面的表现，与美国45至84岁平均风险成年人的筛查结肠镜检查相比。ECLIPSE研究包括34个州农村和城市社区的200多个临床试验点。

Study data includes 12% Black, 13% Hispanic and 7% Asian American populations. Enrollment among Black Americans was above average for a clinical trial, which is important given the disproportionate impact of CRC on the Black community.10.

研究数据包括12%的黑人，13%的西班牙裔和7%的亚裔美国人。美国黑人的入学率高于临床试验的平均水平，鉴于CRC对黑人社区的不成比例的影响，这一点很重要。

About Shield

关于Shield

The Shield test for colorectal cancer screening is commercially available for eligible individuals by prescription only through healthcare professionals. This LDT (Laboratory Developed Test) is intended to be complementary to, and not a replacement for, current recommended CRC screening methods. A negative result does not rule out the presence of cancer.

只有通过医疗保健专业人员的处方，符合条件的个人才能通过Shield测试进行结肠直肠癌筛查。该LDT（实验室开发的测试）旨在补充而不是替代当前推荐的CRC筛查方法。阴性结果不排除癌症的存在。

Patients with an abnormal blood-based screening result should be referred for a diagnostic colonoscopic evaluation..

血液筛查结果异常的患者应转诊进行诊断性结肠镜检查。

about Guardant Health

关于Guardant Health

Guardant Health is a leading precision medicine company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics.

Guardant Health是一家领先的精准医学公司，专注于维护健康，让每个人有更多的时间远离癌症。Guardant成立于2012年，通过先进的血液和组织测试、真实世界数据和人工智能分析，提供对疾病驱动因素的重要见解，正在改变患者护理。

Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer.

Guardant测试有助于改善各个护理阶段的结果，包括早期筛查癌症，监测早期癌症的复发情况，以及帮助医生为晚期癌症患者选择最佳治疗方法。