NEW YORK – Precision oncology firm AccuraGen is eyeing the minimal residual disease (MRD) testing market with a whole-genome sequencing (WGS) liquid biopsy assay, which promises to deliver high sensitivity, specificity, and a fast turnaround time.

纽约–精准肿瘤学公司AccuraGen正在通过全基因组测序（WGS）液体活检检测来瞄准最小残留病（MRD）检测市场，该检测有望提供高灵敏度，特异性和快速周转时间。

The San Jose, California-based company recently published a peer-reviewed study demonstrating the feasibility and utility of its assay, which it developed in-house and hopes to offer as a clinical service in 2026.

这家总部位于加利福尼亚州圣何塞的公司最近发表了一项经过同行评审的研究，证明了其检测方法的可行性和实用性，该公司内部开发了该方法，并希望在2026年将其作为临床服务提供。

Dubbed AccuScan, AccuraGen's MRD test is a tumor-informed WGS assay that analyzes a patient's circulating tumor DNA but does not require bespoke reagents, said Li Weng, AccuraGen's senior VP of R&D.

AccuraGen的研发高级副总裁李翁（Li Weng）表示，AccuraGen的MRD测试被称为AccuScan，是一种基于肿瘤的WGS检测方法，可以分析患者的循环肿瘤DNA，但不需要定制试剂。

As part of the AccuScan workflow, cell-free DNA (cfDNA) is isolated from a patient's posttreatment plasma sample and is subsequently denatured and circularized through intramolecular ligation. After that, the circularized DNA molecules undergo rolling circle amplification, generating concatemers that contain tandem copies of the template molecules.

作为AccuScan工作流程的一部分，从患者的治疗后血浆样品中分离出无细胞DNA（cfDNA），随后通过分子内连接进行变性和环化。之后，环化的DNA分子进行滚环扩增，产生包含模板分子串联拷贝的连接体。

The concatemers are then sequenced and aligned to the human reference genome. .

。

Meanwhile, a patient's tumor tissue is also analyzed using WGS to inform patient-specific mutations. Together with the tumor sequences, the cfDNA mutational profile is processed by AccuScan's analysis pipeline to help determine a patient's MRD status.

。与肿瘤序列一起，cfDNA突变谱由AccuScan的分析管道处理，以帮助确定患者的MRD状态。

According to Weng, there are a few advantages to the AccuScan assay. For one, she said the workflow's intramolecular ligation step is 'very efficient,' allowing the assay to accommodate samples with a low DNA input. Additionally, unlike conventional PCR, AccuScan's rolling circle amplification step does not propagate errors, she said.

。首先，她说，该工作流程的分子内连接步骤“非常有效”，使该测定能够适应DNA输入量低的样品。此外，与传统的PCR不同，AccuScan的滚环扩增步骤不会传播错误，她说。

This allows the assay to achieve error suppression by only analyzing true mutations, which are present on all repeat elements of a concatemer. .

这使得该测定法仅通过分析存在于连接体的所有重复元件上的真实突变来实现错误抑制。

Moreover, Weng noted that rolling circle-amplified WGS libraries can also be harnessed for targeted sequencing, allowing users to revisit the samples for therapy target selection or drug resistance testing after a patient is deemed MRD-positive by AccuScan.

。

Last month, AccuraGen researchers and their collaborators from the US and China published a study in EMBO Molecular Medicine to demonstrate AccuScan's performance. In the study, they applied the assay to a total of 117 plasma samples from 57 cancer patients, including 32 with colorectal cancer (CRC), 17 with esophageal squamous cell carcinoma (ESCC), and eight with melanoma.

上个月，来自美国和中国的AccuraGen研究人员及其合作者在EMBO分子医学杂志上发表了一项研究，以证明AccuraGen的性能。在这项研究中，他们对57名癌症患者的117份血浆样本进行了检测，其中32份患有结直肠癌（CRC），17份患有食管鳞状细胞癌（ESCC），8份患有黑色素瘤。

The CRC and ESCC samples were collected from hospitals in Shanghai, while the melanoma samples were obtained from the Yale School of Medicine..

CRC和ESCC样本来自上海的医院，而黑色素瘤样本来自耶鲁大学医学院。。

Overall, the study noted that AccuScan has 'a high success rate' in handling cfDNA samples across a wide range of input amounts, with the lowest sample input being less than 5 ng. Additionally, the study authors concluded that the test can achieve genome-wide error correction at a single read level, enabling an ultralow limit of detection down to the parts-per-million (PPM) range in analytical studies..

总体而言，该研究指出，AccuScan在处理各种输入量的cfDNA样品方面具有“高成功率”，最低样品输入量小于5ng。此外，研究作者得出结论，该测试可以在单次读取水平上实现全基因组错误校正，使分析研究中的检测限超低至百万分之几（PPM）。。

When applied to MRD detection, AccuScan achieved 90 percent sensitivity, 100 percent specificity, and 96.3 percent accuracy in plasma samples collected from CRC patients within six weeks after surgery. For ESCC patients, AccuScan achieved 67 percent sensitivity, 100 percent specificity, and 82.4 percent accuracy using plasma samples collected within one week after surgery.

当应用于MRD检测时，AccuScan在手术后6周内从CRC患者收集的血浆样本中获得了90%的灵敏度，100%的特异性和96.3%的准确性。对于ESCC患者，使用术后一周内收集的血浆样本，AccuScan获得了67%的敏感性，100%的特异性和82.4%的准确性。

.

.

The researchers also explored AccuScan's utility for immunotherapy monitoring using 22 plasma samples from eight melanoma patients with advanced melanoma. There, the study authors concluded that AccuScan's results showed 'strong correlations' with clinical outcomes.

研究人员还利用8名患有晚期黑色素瘤的黑色素瘤患者的22份血浆样本，探索了AccuScan在免疫治疗监测中的应用。在那里，研究作者得出结论，AccuScan的结果显示与临床结果“密切相关”。

'To me, it was quite impressive [to see AccuScan's] sensitivity, specificity, and the low amount of starting material [required],' said Marcus Bosenberg, director of the Yale Center for Immuno-Oncology, a coauthor on the paper, and a collaborator of AccuraGen.

耶鲁大学免疫肿瘤学中心主任马库斯·博森伯格（MarcusBosenberg）是该论文的合著者，也是AccuraGen的合作者，他说：“对我来说，（看到AccuScan的）敏感性、特异性和（所需的）起始材料量都很低，这让我印象深刻。”。

Because AccuScan does not involve building patient-specific regents, another advantage of the assay is the faster turnaround time, said Qin Yan, a professor of pathology at Yale and another collaborator of AccuraGen. According to Weng, the current turnaround time for AccuScan, from sample to report, is about two weeks.

耶鲁大学病理学教授、AccuraGen的另一位合作者秦燕表示，由于AccuScan不涉及构建针对患者的试剂，因此该测定法的另一个优点是周转时间更快。据翁介绍，AccuScan目前从样本到报告的周转时间约为两周。

.

.

With the proof of concept, Weng said AccuraGen is now working to commercialize AccuScan as a research-use-only service for basic and translational researchers beginning in the second half of 2025.

翁说，有了概念验证，AccuraGen现在正在努力将AccuScan商业化，从2025年下半年开始，它是一种仅供基础和转化研究人员使用的研究服务。

More importantly, the company plans to develop AccuScan into a laboratory-developed test, which it hopes to offer as a service to oncologists and pharmaceutical companies in the US in early 2026. To achieve that, Weng said AccuraGen is focusing on seeking strategic partners who are already operating clinical labs in hopes of bringing the technology to the market sooner, but the company could also build its own clinical lab..

更重要的是，该公司计划将AccuScan开发成实验室开发的测试，希望在2026年初为美国的肿瘤学家和制药公司提供服务。翁说，为了实现这一目标，AccuraGen正专注于寻找已经在运营临床实验室的战略合作伙伴，以期尽快将该技术推向市场，但该公司也可以建立自己的临床实验室。。

Weng said the company is also interested in eventually developing AccuScan into kitted products, given that the technology can be more easily scalable and distributable without the need for personalized reagents.

翁说，该公司也有兴趣最终将AccuScan开发成配套产品，因为该技术可以更容易地扩展和分发，而无需个性化试剂。

To make the assay more economical, AccuScan is currently optimized for Complete Genomics' DNBSeq platform, which deems to have a per-GB lower cost than many other sequencing platforms, Weng said, though she did not disclose a specific price tag for the test. However, she noted that the AccuScan technology is fundamentally sequencer-agnostic, and the company has evaluated the assay on Illumina and Element Biosciences sequencers with 'comparable' results.

为了使测定更经济，AccuScan目前针对Complete Genomics的DNBSeq平台进行了优化，该平台被认为比许多其他测序平台的每GB成本更低，翁说，尽管她没有透露该测试的具体价格标签。然而，她指出，AccuScan技术基本上与测序仪无关，该公司已经对Illumina和Element Biosciences测序仪的测定结果进行了评估，结果具有“可比性”。

.

.

Established about a decade ago, AccuraGen ​​initially focused on developing targeted sequencing technologies for liquid biopsy treatment selection and cancer early detection products with an emphasis on the Chinese market, Weng said. Since 2022, the company has shifted its focus to developing the AccuScan technology, as part of its pivot to become a clinical service provider focusing on the US market, she noted.

翁说，AccuraGen成立于大约十年前，最初专注于开发用于液体活检治疗选择和癌症早期检测产品的靶向测序技术，重点是中国市场。她指出，自2022年以来，该公司已将重点转移到开发AccuScan技术，作为其成为专注于美国市场的临床服务提供商的一部分。

.

.

The company has been financially supported by private investors including from Decheng Capital since 2016, and some non-dilutive funding, Weng said, adding that the company is seeking additional funding in the US to fuel the commercialization of AccuScan.

翁表示，自2016年以来，该公司一直得到包括德成资本（Decheng Capital）在内的私人投资者的财务支持，以及一些非稀释性资金，并补充称，该公司正在美国寻求额外资金，以推动AccuScan的商业化。