PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced Clinical Cancer Research, a journal of the American Association for Cancer Research, will publish results today from the COSMOS study confirming the high sensitivity and specificity of the Guardant Reveal blood test in predicting recurrence of colorectal cancer (CRC)..

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，美国癌症研究协会的期刊《临床癌症研究》将于今天公布COSMOS研究结果，证实Guardant Reveal血液检测在预测结直肠癌（CRC）复发方面的高灵敏度和特异性。。

The COSMOS (COnquer Solid Malignancies by blOod Screening) study is the largest study to date evaluating minimal residual disease (MRD) detection using a tissue-free epigenomic approach with the Guardant Reveal test.1 The study assessed more than 1,900 longitudinal surveillance samples from 342 patients with clinical stage I-III resected CRC.2 The study results demonstrated that detection of MRD using the Guardant Reveal test was associated with statistically significant and clinically relevant recurrence prediction at each post-surgical timepoint evaluated for patients with stage II or higher CRC..

COSMOS（通过血液筛查征服实体恶性肿瘤）研究是迄今为止使用无组织表观基因组学方法和Guardant Reveal测试评估最小残留病（MRD）检测的最大研究。该研究评估了来自342名临床I-III期切除CRC患者的1900多个纵向监测样本。研究结果表明，使用Guardant Reveal测试检测MRD与评估II期或更高CRC患者的每个手术后时间点的统计学显着和临床相关复发预测相关。。

“In the COSMOS study, we observed sensitive and specific detection of minimal residual disease in resected colorectal cancer using the Guardant Reveal tissue-agnostic epigenomic-based ctDNA assay,” said Yoshiaki Nakamura, M.D., Ph.D., chief, International Research Promotion Office, Department of Gastroenterology and Gastrointestinal Oncology at National Cancer Hospital East in Chiba, Japan, and a co-lead author of the study.

“在COSMOS研究中，我们观察到使用Guardant Reveal tissue不可知的基于表观基因组的ctDNA测定法对切除的结直肠癌中的微小残留疾病进行了敏感和特异的检测，”医学博士Yoshiaki Nakamura说，他是日本千叶国立癌症医院东胃肠病学和胃肠肿瘤学系国际研究促进办公室主任，也是该研究的联合首席作者。

“The use of a tissue-free assay offers healthcare systems significant logistical advantages by reducing the burden of tissue handling, as well as a shorter initial turnaround time for the result during the adjuvant decision-making window, while maintaining overall longitudinal performance comparable to previously reported tissue-informed approaches.”.

“无组织检测的使用通过减轻组织处理的负担，以及在辅助决策窗口期间缩短结果的初始周转时间，同时保持与先前报道的组织相当的总体纵向性能，为医疗保健系统提供了显着的后勤优势。知情方法。”。

Key study findings include:

主要研究结果包括：

100% of patients were able to undergo evaluation without the need for tissue testing

100%的患者能够在不需要组织测试的情况下进行评估

98% specificity in samples from patients without recurrence

无复发患者样本的特异性为98%

81% longitudinal sensitivity for recurrence in stage II or higher colon cancer

II期或更高结肠癌复发的纵向敏感性为81%

5.3-month median lead time from ctDNA detection to recurrence

从ctDNA检测到复发的5.3个月中位前置时间

“Studies have established an association between the presence of residual disease after surgery and a higher probability of recurrence in early-stage colon cancer,” said Craig Eagle, M.D., Guardant Health chief medical officer. “The COSMOS study provides strong support for the use of the Guardant Reveal test to help inform adjuvant therapy decisions for patients with stage II or III colon cancer and, in post-treatment surveillance, to detect recurrence earlier than standard of care.”.

Guardant Health首席医疗官医学博士克雷格·伊格尔（CraigEagle）说：“研究已经证实，手术后残留疾病的存在与早期结肠癌复发的可能性之间存在关联。”。“COSMOS研究为使用Guardant Reveal测试提供了强有力的支持，以帮助为II期或III期结肠癌患者的辅助治疗决策提供信息，并在治疗后监测中，比标准治疗更早地发现复发。”。

The study will be published at 10:00 am EDT on August 7 in Clinical Cancer Research.

该研究将于美国东部夏令时8月7日上午10:00在《临床癌症研究》上发表。

About Guardant Reveal

关于Guardant Reveal

The first tissue-free test for minimal residual disease (MRD) detection in colorectal cancer, Guardant Reveal is also available for breast and lung cancers. Requiring only a simple blood draw, the test interrogates thousands of epigenomic signals to precisely quantify tumor fraction, offering sensitive and specific MRD results in under 10 days to inform timely clinical decisions in the post-surgery and surveillance settings in early-stage cancer.

Guardant Reveal是第一个用于结直肠癌最小残留病（MRD）检测的无组织检测方法，也可用于乳腺癌和肺癌。该测试只需要简单的抽血，就可以查询数千个表观基因组信号，以精确量化肿瘤分数，在不到10天的时间内提供敏感和特异的MRD结果，为早期癌症手术后和监测环境中的及时临床决策提供信息。

Guardant Reveal is a Laboratory Developed Test (LDT) with performance characteristics determined by the Guardant Health clinical laboratory in Redwood City, California, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing.

Guardant Reveal是一种实验室开发的测试（LDT），其性能特征由加利福尼亚州红木市的Guardant Health临床实验室确定，该实验室根据1988年临床实验室改进修正案（CLIA）认证为有资格进行高复杂度临床测试。

This test has not been reviewed or approved by the U.S. Food and Drug Administration (FDA)..

该测试尚未经美国食品和药物管理局（FDA）审查或批准。。

About Guardant Health

关于Guardant Health

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

Guardant Health是一家领先的精准肿瘤学公司，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、现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，正在改变患者护理并加速新的癌症治疗。

Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook..

Guardant测试有助于改善所有护理阶段的结果，包括筛查以早期发现癌症，监测早期癌症的复发以及晚期癌症患者的治疗选择。有关更多信息，请访问guardanthealth.com，并在LinkedIn、X（推特）和Facebook上关注该公司。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements.

本新闻稿包含联邦证券法意义下的前瞻性声明，包括关于Guardant Health液体活检测试或检测的潜在效用、价值、益处和优势的声明，这些声明涉及可能导致实际结果与这些前瞻性声明中表达的预期结果和期望存在重大差异的风险和不确定性。

These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2023, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter.

这些声明基于当前的预期、预测和假设，由于多种因素，实际结果和结果可能与这些声明存在重大差异。这些以及可能影响Guardant Health财务和经营成果并导致实际结果与本新闻稿中前瞻性声明所示结果产生重大差异的其他风险和不确定性包括“风险因素”和“管理层对财务状况和经营成果的讨论和分析”标题下的讨论以及截至2023年12月31日的10-K表年度报告中的其他内容，以及此后提交给证券交易委员会的任何当前和定期报告。

The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law.

本新闻稿中的前瞻性声明基于截至本新闻稿发布之日Guardant Health可获得的信息，Guardant Health不承担更新任何前瞻性声明的义务，以反映其预期的任何变化或任何此类声明所依据的事件、条件或情况的任何变化，除非法律要求。

These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release..

这些前瞻性声明不应被视为代表Guardant Health在本新闻稿发布日期之后的任何日期的观点。。

References

参考文献

1. Nakamura Y, Tsukada Y, Matsuhashi N, et al. Colorectal cancer recurrence prediction using a tissue-free epigenomic minimal residual disease assay. Clin Cancer Res 2024. doi: 10.1158/1078-0432.CCR-24-1651. In press.

1.Nakamura Y，Tsukada Y，Matsuhashi N等人。使用无组织表观基因组最小残留病测定法预测结直肠癌复发。临床癌症研究2024。doi:10.1158/1078-0432.CCR-24-1651。正在印刷中。

2. Samples were collected at day 28 and every 3 to 6 months post-operatively for up to five years or until clinical recurrence.

2.在术后第28天和每3至6个月收集样本，长达5年或直至临床复发。