NEW YORK – Caris Life Sciences, which last month

纽约——Caris Life Sciences，上个月

raised nearly $500 million

筹集了近5亿美元

in an initial public offering of stock, has been building a business for several years in comprehensive genomic profiling for cancer, and a new study published last week has showcased its platform's ability to not only inform therapeutic decision-making but also detect developing tumors and monitor lingering or reemerging disease in patient blood samples..

在首次公开募股股票发行中，已经建立了多年的业务，专注于癌症的综合基因组分析，上周发布的一项新研究展示了其平台不仅能够为治疗决策提供信息，还可以检测正在发展的肿瘤并监测患者血液样本中残留或重新出现的疾病。

These new areas, cancer early detection and minimal residual disease (MRD), have captured increasing attention from commercial cancer testing firms in recent years, but most companies have been in a position where they have had to develop unique, independent platforms for these different applications.

近年来，这些新领域——癌症早期检测和微小残留病（MRD）——已经引起了商业癌症检测公司的越来越多的关注，但大多数公司一直处于必须为这些不同的应用开发独特、独立平台的境地。

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Caris CEO David Spetzler said in an interview this week that because his firm's approach to cancer genotyping began with a comprehensive approach to both DNA and RNA sequencing, it believes it is in a unique position to be able to use the same platform in these new indications.

卡里斯首席执行官大卫·斯佩茨勒本周在一次采访中表示，由于他的公司在癌症基因分型方面的方法始于对DNA和RNA测序的全面综合处理，因此公司认为自己能够利用同一平台应用于这些新的适应症，具有独特的优势。

'Everyone else is making a separate assay for each niche, so MRD is different than early detection, is different than therapy selection, and we think that that's a less desirable approach because it doesn't take advantage of the fact that you can learn so much more If you standardize and unify the data that you get across every patient,' he said..

“其他所有人都是为每个细分领域分别进行检测，所以MRD与早期检测不同，与治疗选择也不同，我们认为这种方法不太可取，因为它没有利用到一个事实，即如果你能标准化并统一每位患者的数据，你能学到的会多得多，”他说道。

'More than focusing on a particular clinical application, this new paper is a platform paper, and the power comes from showing that you can have a single assay that does everything,' he added.

“与其说专注于某个特定的临床应用，这篇新论文是一篇平台论文，其强大之处在于展示了你可以拥有一个全能的单一检测方法，”他补充道。

Caris' clinical testing platform, called Caris Assure, is based on a backbone of whole exome and transcriptome sequencing, with machine learning for algorithmic assessment of features beyond simple gene alterations. The company offers both tissue and blood-based testing.

Caris的临床测试平台名为Caris Assure，基于全外显子组和转录组测序的核心技术，并利用机器学习对超出简单基因变异的特征进行算法评估。该公司提供组织和血液两种检测方式。

In the new study,

在新研究中，

published July 1

发表于7月1日

in the journal

在期刊中

Scientific Reports

科学报告

, researchers shared data from validation of the Caris Assure liquid biopsy system in over 376,000 whole-exome and whole-transcriptome tissue profiles and over 7,000 matched blood and tissue samples.

研究人员分享了Caris Assure液体活检系统在超过376,000个全外显子组和全转录组组织样本以及超过7,000个匹配的血液和组织样本中的验证数据。

The company trained three machine-learning models using subsets from this cohort — one for multi-cancer early detection, one for determining tumor location, and one for minimal residual disease detection and monitoring.

该公司使用该队列的子集训练了三个机器学习模型——一个用于多癌症早期检测，一个用于确定肿瘤位置，另一个用于微小残留病灶检测和监测。

The authors reported sensitivity for early cancer detection across a variety of tumor types of between 83 percent and 96 percent at nearly 100 percent specificity. They also demonstrated that the platform can guide diagnosis based on prediction of a tumor's location.

作者报告称，在几乎 100% 的特异性下，早期癌症检测在各种肿瘤类型中的敏感性介于 83% 至 96% 之间。他们还证明，该平台可以根据对肿瘤位置的预测来指导诊断。

Sensitivities for stage I to stage IV cancers were 83 percent, 86 percent, 84 percent, and 96 percent, respectively.

I期到IV期癌症的敏感性分别为83％、86％、84％和96％。

Additional data also showed that Assure can predict cancer recurrence based on detection of lingering tumor DNA in the blood and can provide a monitoring readout of tumor activity in response to treatment.

额外的数据还显示，Assure能够基于对血液中残留的肿瘤DNA的检测预测癌症复发，并且可以提供治疗过程中肿瘤活动的监测结果。

According to the authors, the disease-free survival of patients whose cancers were MRD-positive in the study was significantly shorter than that of those who didn't show signs of MRD.

根据作者的说法，研究中癌症为MRD阳性的患者的无病生存期显著短于那些没有显示MRD迹象的患者。

Spetzler said the study essentially lays the groundwork for expanding into early detection, MRD, and therapeutic monitoring, where the firm is currently pursuing reimbursement and regulatory pathways to support clinical launches in specific use cases. There are several of these in the MRD and monitoring sphere, he said, but for early detection, the company's first target will be breast cancer..

斯佩茨勒说，这项研究本质上为扩展到早期检测、微小残留病（MRD）和治疗监测奠定了基础。该公司目前正在寻求报销和监管途径，以支持在特定用例中的临床推广。他说，在微小残留病和监测领域有几个这样的用例，但对于早期检测，公司的第一个目标将是乳腺癌。

Most early-detection competitors already on the market have either targeted colorectal cancer or multi-cancer early strategies. Others in development are focused on lung and pancreatic cancers. Breast cancer, like CRC, Spetzler said, is a rational initial target for clinical commercialization because there is already a screening paradigm in place, namely mammography..

大多数已经上市的早期检测竞争者要么针对结直肠癌，要么采用多癌症早期策略。其他正在开发中的则专注于肺癌和胰腺癌。斯佩茨勒说，乳腺癌和结直肠癌一样，是临床商业化的合理初始目标，因为已经有了一种筛查模式，即乳腺X光摄影。

That means that there is a benchmark against which Caris can test its own technology — a bar set that it can show it can meet or surpass. 'It's much easier to assess early detection performance when a screen is already available,' said Spetzler.

这意味着存在一个基准，可以用来测试 Caris 自身的技术——一个它可以证明自己能够达到或超越的标准。斯佩茨勒表示：“当筛查方法已经可用时，评估早期检测性能会容易得多。”

In the company's current publication, sensitivity for breast cancer detection was at least equivalent to mammography, he said, and in newer data that that the firm hopes to publish soon, it expects to demonstrate even better results.

他说，在公司目前的出版物中，乳腺癌检测的敏感性至少与乳房X光检查相当，而在公司希望尽快发布的新数据中，预计将展示更好的结果。

The decision to take an approach that focuses on one tumor type at a time is a conscious one, Spetzler said.

斯佩茨勒说，选择一次专注于一种肿瘤类型的方法是有意识的决定。

'Launching in some of these indications, it's so, so hard to know what you're doing, and we don't want to make claims that we can't really thoroughly substantiate. We'd rather over-deliver than overpromise,' he said.

“在其中一些适应症上推出产品时，真的很难知道我们在做什么，我们不想做出无法完全证实的声明。我们宁愿做得比说得多。”他说。

That doesn't mean that if the company's platform yields other findings, it will ignore them, but it doesn't plan to market its test for indications where it doesn't have solid data. In recent debates about multi-cancer tests, including Grail's Galleri assay, which is already clinically available,

这并不意味着如果公司的平台产生其他发现，它会忽略它们，但公司不打算将其测试推广到没有确凿数据支持的领域。在最近关于多癌检测的讨论中，包括Grail已经临床可用的Galleri检测，

questions have been raised

问题已经被提出

about the right of patients to access these technologies, if they have the means to pay for them, even if clinical utility data is lacking.

关于患者获取这些技术的权利，如果他们有支付能力，即使缺乏临床效用数据。

Spetzler said he agrees that this is a valid concern, as long as companies marketing tests are clear about what a patient is getting and what they're not. 'In terms of the claims for multi-cancer early detection, the rates are pretty fine for late-stage disease, but that's already too late by then to intervene.

斯佩茨勒表示，他同意这是一个合理的担忧，只要营销测试的公司明确告知患者能得到什么以及不能得到什么。“就多癌症早期检测的主张而言，对于晚期疾病，检测率相当不错，但到那时再进行干预已经太晚了。”

… It's really got to be that stage I and stage II performance that matters,' he argued..

…他争辩说，真正重要的是一阶段和二阶段的表现。

The great thing, Spetzler said, about Caris' technology and approach to clinical testing, is that it is constantly amassing comprehensive sequencing data, as it provides narrower, validated clinical findings. This means the adaptation of its platform is ever evolving, and data to support additional indications, whether in early detection, MRD, or elsewhere, is just a matter of time..

斯佩茨勒说，Caris 技术和临床测试方法的最大特点在于，它在提供更精确、经过验证的临床结果的同时，不断积累全面的测序数据。这意味着其平台的适应性在不断发展，支持更多适应症的数据，无论是早期检测、微小残留病灶（MRD）还是其他领域，只是时间问题。

Another positive aspect of the firm's platform, according to Spetzler, is that it already incorporates both DNA sequencing and transcriptomics. He said emerging biological evidence is making it clearer and clearer that because different tumors operate differently, there is no one signal that can best capture them, especially in their early development..

据斯佩茨勒称，该公司平台的另一个积极方面是它已经结合了DNA测序和转录组学。他表示，新兴的生物学证据越来越清楚地表明，由于不同的肿瘤运作方式不同，没有一种信号能够最好地捕捉到它们，尤其是在它们的早期发展阶段。

For example, he said, DNA methylation works well in specific tumor types like colorectal cancer, which tends to be driven by those changes. But tests that can detect CRC at high sensitivity do poorly with other tumor types like breast and prostate cancer.

例如，他说，DNA甲基化在特定的肿瘤类型（如结直肠癌）中效果很好，这种癌症往往由这些变化驱动。但是，能够以高灵敏度检测结直肠癌的测试在其他肿瘤类型（如乳腺癌和前列腺癌）上表现较差。

'For us, it's clear that if we only look at copy number, it's not as good as when you add in expression, plus fusions, plus mutations, plus fragments, plus histone patterning, looking at transcription,' Spetzler said. 'Having the same test used across the entire continuum of care is the only way we're going to discover how to do things better.'.

“对我们来说，很明显，如果只看拷贝数，就不如再加上表达、融合、突变、片段和组蛋白模式以及转录情况那么好。”斯佩茨勒说，“在整个护理过程中使用相同的测试，是我们发现如何做得更好的唯一途径。”