NEW YORK – The latest update to the National Comprehensive Cancer Network guidelines for colorectal cancer (CRC) screening include Geneoscopy's ColoSense test, a stool-based multitarget RNA biomarker assay, and Guardant Health's Shield blood-based cell-free DNA test.

纽约——国家综合癌症网络结直肠癌（CRC）筛查指南的最新更新包括Geneoscopy的ColoSense测试，一种基于粪便的多靶点RNA生物标志物检测，以及Guardant Health的Shield血液无细胞DNA测试。

Inclusion of these assays in the guidelines supports their role as a screening alternative for individuals aged 45 years and older who are at average risk for CRC. The NCCN guidelines recommend testing with either of the assays every three years.

将这些检测方法纳入指南支持了它们作为45岁及以上平均风险CRC人群的筛查替代方法的作用。NCCN指南建议每三年使用其中任何一种检测方法进行测试。

ColoSense is designed to detect CRC and advanced adenomas from patient stool samples. It is the only screening test

ColoSense旨在从患者的粪便样本中检测结直肠癌（CRC）和进展期腺瘤。它是唯一的筛查测试。

approved by the US Food and Drug Administration

经美国食品和药物管理局批准

that uses stool RNA biomarkers, which are not subject to age-related methylation, Geneoscopy said.

Geneoscopy公司表示，该方法使用粪便RNA生物标志物，这些标志物不受与年龄相关的甲基化影响。

The assay, which is performed at Geneoscopy's laboratory, comprises the ColoSense collection kit, test kit, and software. It uses the Polymedco iFOBT Analyzer, BioMérieux's EMAG Nucleic Acid Extraction System, and Bio-Rad's QXDx Droplet Digital PCR System.

该检测在Geneoscopy实验室进行，包含ColoSense采集试剂盒、测试试剂盒和软件。它使用Polymedco iFOBT分析仪、BioMérieux的EMAG核酸提取系统以及Bio-Rad的QXDx微滴数字PCR系统。

The test's inclusion in the NCCN guidelines is based on data from the company's CRC-PREVENT study, results of which were

该测试被纳入NCCN指南是基于该公司CRC-PREVENT研究的数据，其结果是

published in 2023

2023年出版

in the

在

Journal of the American Medical Association

美国医学协会期刊

. Nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study showed that ColoSense could detect CRC with 94 percent sensitivity, identifying 100 percent of stage I CRC cases. Additionally, ColoSense detected 46 percent of advanced adenomas, when colorectal cancer is most preventable..

近三分之二的CRC-PREVENT参与者在入组时从未进行过结直肠癌筛查或安排结肠镜检查。研究表明，ColoSense检测结直肠癌的敏感性达94%，能够识别100%的I期结直肠癌病例。此外，ColoSense还检测出了46%的进展期腺瘤，而这一阶段正是结直肠癌最可预防的时期。

'The NCCN guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,' Geneoscopy Chief Commercial Officer Matt Sargent said in a statement. 'Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans.

“NCCN指南对筛查测试的临床应用和保险覆盖范围都有重大影响，”Geneoscopy首席商务官马特·萨金特在一份声明中表示。“作为一线检测手段实现这一里程碑，标志着我们在将ColoSense推向市场、为数百万美国人提供准确且可及的筛查解决方案的使命中迈出了关键一步。”

NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines.'.

纳入NCCN指南也使ColoSense有望未来被纳入其他主要指南。

Guardant's Shield, meanwhile, was

与此同时，Guardant的Shield武器

approved by the FDA

获得FDA批准

as a primary CRC screening option in July 2024.

作为2024年7月主要的结直肠癌筛查选项。

Shield is a test that analyzes blood samples for cfDNA and other biomarkers to identify signs of colorectal cancer or precancer. The next-generation sequencing test is performed using physician-collected blood samples that are shipped to Guardant's laboratories.

Shield是一项通过分析血液样本中的cfDNA和其他生物标志物来识别结直肠癌或癌前病变迹象的测试。这项下一代测序测试使用医生采集的血液样本，这些样本会被送往Guardant的实验室进行检测。

NCCN cited Guardant's ECLIPSE study evaluating the performance of Shield compared to a screening colonoscopy. One of the largest studies of its kind and

NCCN引用了Guardant的ECLIPSE研究，该研究评估了Shield与筛查性结肠镜检查的性能。这是同类研究中规模最大的研究之一，且

published in March 2024

2024年3月出版

in the

在

New England Journal of Medicine

新英格兰医学杂志

, ECLIPSE demonstrated that the Shield blood test had a sensitivity of 83 percent in detecting CRC.

，ECLIPSE 试验证明，Shield 血液检测在检测结直肠癌方面的敏感性为 83%。

'With a simple blood draw, Shield provides a more convenient and pleasant screening option for the millions of eligible Americans who are forgoing their recommended screening for colorectal cancer,' Guardant Health co-CEO AmirAli Talasaz said in a statement. 'This major guideline inclusion from the National Comprehensive Cancer Network is just the first for Shield, and we believe a pivotal step for more patients to benefit from this test.'.

“通过简单的抽血，Shield 为数百万符合条件但放弃接受推荐的结直肠癌筛查的美国人提供了一个更方便、更舒适的筛查选择，”Guardant Health 联席首席执行官 AmirAli Talasaz 在一份声明中表示。“这一来自美国国家综合癌症网络的重要指南纳入只是 Shield 的第一步，我们相信这将是让更多患者从这项测试中受益的关键一步。”