NEW YORK – Guardant Health and ClearNote Health announced this week that their liquid biopsy assays have passed an assessment by the National Cancer Institute to join its Vanguard study, led by investigators in NCI's Cancer Screening Research Network.

纽约——Guardant Health和ClearNote Health本周宣布，他们的液体活检检测已通过国家癌症研究所的评估，加入由NCI癌症筛查研究网络研究人员领导的先锋研究。

Vanguard, which was conceived more than two years ago, is intended to fill gaps in validation data for multi-cancer early detection (MCED) tests, especially regarding the effectiveness of different test technologies across cancer types and stages and the resulting impact on their potential utility or optimal applications..

Vanguard是两年多前构思的，旨在填补多癌症早期检测（MCED）测试验证数据的空白，特别是关于不同测试技术在癌症类型和阶段的有效性以及对其潜在效用或最佳应用的影响。。

Study investigators hope to measure the performance of different assays on a set of tens of thousands of clinical samples to better understand which tests perform best in which scenarios or risk settings.

研究人员希望在数万个临床样本上测量不同检测方法的性能，以更好地了解哪些检测在哪种情况或风险环境下表现最佳。

Lori Minasian, deputy director for the NCI's Division of Cancer Prevention, has argued that it is important to establish these boundaries and subtleties before clinicians can feel comfortable recommending these tests to patients. During a discussion last April at the American Association for Cancer Research annual meeting, Minasian said, 'I think it's hard to appreciate that, even if there are only two or three assays out there, that … they're not all looking at [this] quite the same way.

NCI癌症预防部副主任洛里·米纳西安（LoriMinasian）认为，在临床医生向患者推荐这些测试之前，确定这些界限和微妙之处很重要。在去年4月美国癌症研究协会年会的一次讨论中，米纳西安说，“我认为很难理解，即使只有两到三种检测方法……他们的观点并不完全相同。

The sensitivity for each individual cancer could be very different. And the sensitivity for early stage versus late stage could be even more different.'.

每种癌症的敏感性可能非常不同。早期与晚期的敏感性可能会更加不同。”。

Considering that MCED testing is already clinically available, these questions might be viewed as moot. But practically, the future landscape of regulatory approval and insurance coverage for these tests is still unknown.

考虑到MCED测试已经在临床上可用，这些问题可能被视为没有意义。但实际上，这些测试的监管批准和保险范围的未来前景仍然未知。

In December, the US Congress failed to pass a bipartisan healthcare package that included legislation mandating Medicare coverage for MCED testing, but sponsors are still hopeful that their bill can find its way.

12月，美国国会未能通过一项跨党派的医疗保健计划，其中包括立法要求医疗保险覆盖MCED测试，但赞助商仍然希望他们的法案能够找到出路。

Thus far, only one multi-cancer screening test has been launched commercially — Grail's Galleri. But others, like those from Guardant and ClearNote, have been expected to follow close behind.

到目前为止，只有一项多癌筛查测试已经商业化启动，即圣杯的Galleri。但其他测试，如Guardant和ClearNote的测试，预计将紧随其后。

Vanguard first invited test makers to volunteer for the study in 2022, later saying that at least 18 companies had expressed interest. Study researchers have not named those companies, nor have they yet made public any details on how many went on through the initial technical assessment. This means that companies not participating in the trial could have been assessed and rejected or could have chosen not to apply for inclusion in the first place..

Vanguard于2022年首次邀请测试制造商自愿参与这项研究，后来表示至少有18家公司表示了兴趣。研究人员还没有列出这些公司的名字，也没有公布有多少公司通过了初步技术评估的细节。这意味着，未参与试验的公司可能会被评估并拒绝，或者可能会选择不首先申请纳入。。

The collaborative has stated that it intends to publish a report on more of these early metrics sometime this year.

该协作组织表示，它打算在今年某个时候发布一份关于更多这些早期指标的报告。

ClearNote CEO David Mullarkey said this week that he and his colleagues view their passing of Vanguard's inclusion assessment as a point of pride.

ClearNote首席执行官大卫·穆拉基（DavidMullarkey）本周表示，他和他的同事们将通过Vanguard的包容性评估视为一种骄傲。

'This was a pretty exhaustive process that likely eliminated other companies from being able to participate. It was the most rigorous objective assessment of [MCED] technology providers that we're aware of in the world, and we wanted to see how we stood up to the other available technologies,' he said..

“这是一个相当详尽的过程，可能会使其他公司无法参与。他说，这是我们所知的对（MCED）技术提供商进行的最严格的客观评估，我们想看看我们是如何对抗其他可用技术的。。

The assessment included blinded testing of a set of reference samples, for which assays had to call each sample as either cancer or non-cancer, as well as identify a putative origin site in the body.

该评估包括对一组参考样品进行盲法测试，为此，分析必须将每个样品称为癌症或非癌症，并确定体内推定的起源位点。

ClearNote's technology combines genomic and epigenomic signals, including quantitative measurement of the 5-hydroxymethylcytosine (5hmC) biomarker, a key component of the DNA methylation pathway.

ClearNote的技术结合了基因组和表观基因组信号，包括定量测量5-羟甲基胞嘧啶（5hmC）生物标志物，这是DNA甲基化途径的关键组成部分。

The company has already commercialized two

cancer-specific assays

癌症特异性检测

, which it offers as laboratory-developed tests, one for pancreatic cancer and the other for ovarian cancer. But the firm has always had its sights set on a multi-cancer application. Mullarkey said that the assay being used in Vanguard targets eight tumor types, but the company isn't yet ready to disclose its design in detail..

，它作为实验室开发的测试提供，一种用于胰腺癌，另一种用于卵巢癌。但该公司一直将目光放在多癌症应用上。Mullarkey说，Vanguard使用的检测方法针对八种肿瘤类型，但该公司尚未准备好详细披露其设计。。

In Vanguard, ClearNote and Guardant will be tasked with applying their respective assays to samples from up to 24,000 individuals, including cancer patients and healthy controls.

在Vanguard，ClearNote和Guardant将负责对多达24000名个体（包括癌症患者和健康对照）的样本进行各自的检测。

As of last spring

截至去年春天

,

,

study investigators said

研究调查人员表示

they had already recruited about 1,000 controls and almost 500 cases.

他们已经招募了大约1000名对照和近500名病例。

Similar to ClearNote, Guardant Health has made an initial foray into the clinic targeting a single cancer type while continuing to work internally on expansion to multiple tumor types.

与ClearNote类似，Guardant Health已初步进军针对单一癌症类型的诊所，同时继续在内部致力于扩展到多种肿瘤类型。

Guardant's platform involves methylation sequencing to interrogate cancer-linked, genome-wide epigenomic signals.

Guardant的平台涉及甲基化测序，以询问与癌症相关的全基因组表观基因组信号。

The US Food and Drug Administration

美国食品和药物管理局

approved

已批准

its Guardant Shield assay as a primary colorectal cancer screening option last year, following an FDA

去年，继FDA之后，其Guardant Shield检测作为主要的结直肠癌筛查选择

advisory committee meeting

咨询委员会会议

that resulted in a majority recommendation.

。

In an email, Guardant co-CEO AmirAli Talasaz said that participating in the Vanguard study provides a 'unique opportunity' for the company to engage both the NCI and the FDA.

Guardant联合首席执行官阿米拉利·塔拉萨兹（AmiriTalasaz）在一封电子邮件中表示，参与Vanguard研究为该公司提供了一个“独特的机会”，可以让NCI和FDA都参与进来。

'A major outstanding question in cancer screening is the clinical utility of [MCED] testing. By working with the NCI and the FDA to define follow-up diagnostic pathways for patients post [MCED] testing, we can help ensure that these tests have the greatest benefit for healthcare providers and their patients,' he said..

“癌症筛查中的一个主要突出问题是[MCED]测试的临床实用性。他说：“通过与NCI和FDA合作，为患者（MCED）检测后确定后续诊断途径，我们可以帮助确保这些检测对医疗保健提供者及其患者产生最大的益处。”。。

Talasaz added that the locked Shield algorithm being used in Vanguard is designed to detect and discriminate amongst 10 cancer types — breast, bladder, colorectal, esophageal, gastric, liver, lung, ovarian, pancreas, and prostate cancers.

塔拉萨兹补充说，Vanguard使用的锁定屏蔽算法旨在检测和区分10种癌症类型-乳腺癌，膀胱癌，结直肠癌，食道癌，胃癌，肝癌，肺癌，卵巢癌，胰腺癌和前列腺癌。

Both companies are also pursuing large-scale clinical utility studies in their respective targeted screening applications.

两家公司还在各自的靶向筛查应用中进行大规模临床效用研究。

The NCI's eventual goal with Vanguard is to use the results to inform the same kind of prospective validation trial, hoping to prove not just the validity of multi-cancer screening but also its clinical utility and its ultimate impact on cancer mortality.

NCI与Vanguard的最终目标是利用结果为同类前瞻性验证试验提供信息，希望不仅证明多种癌症筛查的有效性，而且证明其临床实用性及其对癌症死亡率的最终影响。