NEW YORK – While digital PCR has been around for more than three decades and has established itself as a valuable research tool, its use in clinical diagnostics had continued to be a goal more than a reality.

纽约——尽管数字PCR技术已经存在了三十多年，并且已经成为一项有价值的研究工具，但其在临床诊断中的应用仍然是一个目标，而非现实。

But in the cancer space, at least, there are hints that clinicians may be more open to adopting digital PCR to diagnose and manage disease, potentially creating a new paradigm in cancer care.

然而，至少在癌症领域，有迹象表明临床医生可能更愿意采用数字PCR来诊断和管理疾病，这可能会在癌症护理中创造一个新的范式。

Vendors have fine-tuned their development strategies around dPCR cancer assays in the past few years while also gaining traction through partnerships and support of third-party kit developers and service providers. These dPCR users in turn have observed that the technology's benefits — absolute quantitation combined with ever-increasing multiplexing capabilities and lower cost compared to sequencing — are starting to strike a chord in clinical cancer..

在过去几年中，供应商围绕dPCR癌症检测优化了他们的开发策略，同时通过与第三方试剂盒开发商和服务提供商的合作与支持获得了关注。这些dPCR用户反过来观察到，该技术的优势——绝对定量结合不断提升的多重分析能力以及相较于测序的较低成本——正开始在临床癌症领域引起共鸣。

Underlying the ongoing

持续进行的背后

clinical pivot

临床枢纽

for dPCR system makers like Bio-Rad Laboratories, Qiagen, Roche, and Thermo Fisher Scientific is their continued curation of expansive research-use dPCR assay menus. Many of these firms have also launched dedicated diagnostics instruments and are pursuing regulatory approval for their tests and supporting users of their systems to do the same..

对于像Bio-Rad Laboratories、Qiagen、Roche和Thermo Fisher Scientific这样的dPCR系统制造商来说，他们持续整理和扩展用于研究的dPCR检测菜单。这些公司中的许多也推出了专用的诊断仪器，并正在寻求其测试的监管批准，同时支持其系统的用户做同样的事情。

Growing evidence that dPCR is effective and efficient for cancer diagnosis, prognosis, and monitoring is driving its adoption, experts say, citing liquid biopsy, treatment response, minimal residual disease testing, and human papilloma virus-related head-and-neck cancer monitoring as exemplary cases.

专家表示，越来越多的证据表明，数字PCR在癌症诊断、预后和监测方面有效且高效，这正推动其应用，其中液体活检、治疗反应、微小残留病检测以及人乳头瘤病毒相关的头颈部癌症监测是典型案例。

.

。

One reason that digital PCR is increasingly being adopted in clinical applications is that it is 'highly effective at identifying rare cancer-associated genetic changes that might be otherwise missed,' said Chris McKee, CEO and founder of test maker GT Molecular.

GT Molecular公司首席执行官兼创始人克里斯·麦基表示：“数字PCR在临床应用中日益受到青睐的原因之一是，它‘在识别可能被忽略的罕见癌症相关基因变化方面非常有效’。”

Clinicians are appreciating that the technology enables noninvasive cancer detection and assessment through liquid biopsy applications, McKee said, while MRD monitoring can track cancer recurrence or treatment resistance, allowing for early intervention.

麦克基表示，临床医生们越来越认识到，这项技术通过液体活检应用能够实现非侵入性的癌症检测和评估，而微小残留病监测可以追踪癌症复发或治疗耐药性，从而允许早期干预。

Importantly, digital PCR can do these jobs faster and more cost-effectively than next-generation sequencing approaches, he said.

他说，重要的是，数字PCR可以比下一代测序方法更快、更经济地完成这些工作。

Steve Kulisch, Bio-Rad's VP of global marketing, noted that in addition to closely monitoring market needs and trends to help focus product development, his firm is growing the space through

史蒂夫·库利施，Bio-Rad全球营销副总裁，指出除了密切关注市场需求和趋势以帮助集中产品开发外，他的公司还通过以下方式在该领域进行扩展：

clinical research

临床研究

collaborations that generate evidence and help develop new applications.

产生证据并帮助开发新应用的合作。

Similarly, although it was not a formal collaboration, Bio-Rad recently

同样，尽管这不是一次正式的合作，Bio-Rad最近

provided reagents and an instrument to

提供的试剂和仪器

a team at New York University that

纽约大学的一个团队

developed

开发

a 20-minute dPCR protocol using the QX200, potentially enabling molecularly guided brain tumor surgery.

使用QX200的20分钟dPCR协议，可能实现分子引导的脑肿瘤手术。

In clinical oncology overall, however, the use of different analytical methodologies continues to be dynamic, and the appropriateness and utility of dPCR versus qPCR, proteomics, or sequencing is the subject of ongoing clinical research. As sequencing- and qPCR-based oncology testing is also burgeoning, most experts seem to see these analytical methodologies playing nicely together in the care continuum..

然而，在临床肿瘤学整体上，不同分析方法的使用仍在不断发展，dPCR与qPCR、蛋白质组学或测序的适用性和实用性仍是正在进行的临床研究的主题。随着基于测序和qPCR的肿瘤学检测也在迅速发展，大多数专家似乎认为这些分析方法在护理过程中能够很好地协同工作。

'Different technologies can be used to answer different questions, for different samples, and in a complementary way,' explained Kay Eron, VP and general manager for dPCR platforms in Thermo Fisher's life sciences solutions group. For example, NGS testing supports comprehensive gene target screening, while dPCR can subsequently be deployed for personalized biomarker quantification..

“不同的技术可以用来回答不同的问题，针对不同的样本，并且可以相辅相成，”赛默飞世尔科技生命科学解决方案部门dPCR平台的副总裁兼总经理凯·埃隆解释道。例如，NGS检测支持全面的基因靶点筛选，而dPCR则可以随后用于个性化生物标志物的量化。

Jonathan Arnold, VP and head of Qiagen's precision medicine franchise, said competition from other methods is not dampening dPCR's uptake. Instead, 'we're seeing accelerating momentum,' Arnold said, in part because dPCR 'offers a unique combination of ultrahigh sensitivity, absolute quantification, shorter turnaround times, and greater cost-effectiveness compared to NGS.'.

乔纳森·阿诺德（Jonathan Arnold），Qiagen公司副总裁兼精准医疗业务负责人表示，来自其他方法的竞争并未减缓数字PCR（dPCR）的采用。相反，“我们看到了加速的势头，”阿诺德说，这部分是因为dPCR“相比下一代测序（NGS），提供了超高灵敏度、绝对定量、更短的周转时间和更高成本效益的独特组合。”

Digital PCR is also much

数字PCR也更加

more reproducible

更加可重复

within and between labs and experiments than qPCR, according to Wim Trypsteen at Ghent University's DIGPCR center. Initial results from a comparison study by Trypsteen and his team show this holds across all major dPCR platforms, an attribute of the method that potentially benefits customers.

根据根特大学DIGPCR中心的Wim Trypsteen的说法，数字PCR在实验室内部和实验室之间以及不同实验之间的结果一致性比qPCR更高。Trypsteen及其团队进行的一项比较研究的初步结果表明，这一优势涵盖了所有主要的dPCR平台，这也是该方法的一个特性，可能使客户受益。

Although Trypsteen sees broader adoption of dPCR in clinical oncology currently impeded by knowledge gaps among providers, payors, and potential customers, the balance is starting to shift, he said.

特里普斯廷表示，尽管他认为目前供应商、支付方和潜在客户之间的知识鸿沟阻碍了dPCR在临床肿瘤学中的广泛应用，但这种局面正在开始转变。

Quantitation and multiplexing

定量和多重分析

Qiagen launched its first digital PCR platform, the QiAcuity instrument, in 2020. Since then, the firm's strategies have evolved significantly to track with market needs, according to Carola Schade, VP and head of Qiagen's dPCR business.

Qiagen于2020年推出了其首个数字PCR平台——QiAcuity仪器。该公司数字PCR业务副总裁兼负责人卡罗拉·沙德表示，自那时以来，公司的战略已显著发展，以紧跟市场需求。

'Initially, dPCR was seen primarily as a high-precision research tool,' Schade said. 'In recent years, we've seen strong clinical demand for dPCR's sensitivity and absolute quantification capabilities — especially in applications like hematologic malignancies, treatment monitoring, and liquid biopsy testing.'.

“最初，dPCR主要被视为一种高精度的研究工具，”沙德说。“近年来，我们看到了对dPCR敏感性和绝对定量能力的强烈临床需求——尤其是在血液系统恶性肿瘤、治疗监测和液体活检测试等应用中。”

Absolute quantification of rare targets, without the need to generate a standard curve, as is the case with qPCR, could be a game changer for applications like MRD or treatment monitoring.

绝对定量稀有目标，无需像qPCR那样生成标准曲线，可能成为MRD或治疗监测等应用的变革者。

Piyush Gupta, founder and chief science and technology officer of diagnostic developer Naveris, sees two other key trends amplifying dPCR's expansion — increasing multiplexing capabilities and the potential for integrated multiomic platforms that can measure both nucleic acids and proteins.

Naveris诊断开发公司的创始人兼首席科学和技术官皮尤什·古普塔看到了另外两个推动dPCR扩展的关键趋势——多重分析能力的提升以及能够同时测量核酸和蛋白质的综合多组学平台的潜力。

Multiplexing dPCR is 'particularly exciting,' Gupta said, because the ability to assess a vast number of biomarkers in a single run is seen as one of the main advantages of NGS.

Gupta 表示，多重 dPCR“特别令人兴奋”，因为能够在单次运行中评估大量生物标志物被认为是 NGS 的主要优势之一。

Head and neck cancers are one area where dPCR is increasingly being adopted for diagnosis and treatment monitoring, particularly for cases caused by human papillomavirus infection. Overall, cases have been

头颈部癌症是dPCR越来越多地被用于诊断和治疗监测的一个领域，特别是对于由人乳头瘤病毒感染引起的病例。总体而言，病例数量已经

rising

升起

, and there were approximately 1.5 million cases of head and neck cancer and 500,000 deaths globally in 2020.

，2020年全球大约有150万例头颈癌病例和50万例死亡。

Naveris' NavDx HPV test for head and neck cancers uses Bio-Rad's Droplet Digital PCR, also called ddPCR, but Gupta said his team is also actively working on multiomics innovations as well as considering collaborations with other dPCR vendors.

Naveris公司用于头颈癌的NavDx HPV测试使用了Bio-Rad的微滴式数字PCR（也称为ddPCR），但Gupta表示，他的团队也在积极探索多组学创新，并考虑与其他dPCR供应商合作。

At testing service provider Biodesix, meanwhile, Chief Development Officer Gary Pestano said that his team uses multiple platforms, with a focus on Bio-Rad's QX200. It also uses the Bio-Rad QX ONE for its multiplexing capabilities as well as quantitation, Pestano said, while its molecular residual disease application being developed with collaborators at Memorial Sloan Kettering Cancer Center uses the Bio-Rad QX600, which he said provides an even higher order of multiplexing and quantitation..

同时，在测试服务提供商Biodesix，首席发展官加里·佩斯坦诺表示，他的团队使用多个平台，主要聚焦于Bio-Rad的QX200。佩斯坦诺还称，团队也使用Bio-Rad QX ONE来实现其多重分析能力和定量功能，而与纪念斯隆凯特琳癌症中心的合作者共同开发的分子残留病应用则使用Bio-Rad QX600，他表示该平台提供了更高层次的多重分析和定量能力。

'Increasingly, we are also seeing quantitation become a strong driver for technology choice as molecular monitoring studies are being undertaken,' Pestano said.

佩斯塔诺说：“随着分子监测研究的开展，我们越来越多地看到定量分析成为技术选择的重要驱动力。”

Multiplexing dPCR can be enabled by increasing the number of optical channels in instrumentation, and here Stilla Technologies, an

通过增加仪器中的光学通道数量，可以实现dPCR的多重分析，这里Stilla Technologies，一家

oncology-focused

肿瘤学-focused

instrument maker which is

仪器制造商是

being acquired

被收购

by Bio-Rad, currently leads the way with

由Bio-Rad公司提供的，目前处于领先地位。

seven

七

channels, while the QX600 is a six-channel system that enables higher multiplexing.

通道，而 QX600 是一个六通道系统，能够实现更高的多路复用。

Novel chemistry approaches from providers like Pxlence and

Pxlence等供应商提供的新颖化学方法

ChromaCode

色码

are also increasing the number of targets that can be detected per reaction, while a 31-plex liquid biopsy test using a drop-off probe method

还增加了每次反应可检测到的目标数量，而使用脱落探针方法的31重液态活检测试

developed

开发

by Stilla collaborators in France is a good example of high multiplexing research.

法国Stilla公司的合作者是高多重性研究的一个很好的例子。

'If digital PCR platforms can achieve an order of magnitude increase in biomarker multiplexing, their unmatched sensitivity and single-molecule detection could make them serious contenders to displace NGS for blood-based cancer detection, especially in low-abundance settings where performance is paramount,' Gupta said..

“如果数字PCR平台能够在生物标志物多重检测方面实现数量级的提升，其无与伦比的灵敏度和单分子检测能力可能使它们成为取代NGS进行基于血液的癌症检测的有力竞争者，尤其是在性能至关重要的低丰度环境中，”Gupta说道。

Ghent University's Trypsteen also said that while dPCR's cost per sample compared to qPCR is often cited as an obstacle to adoption, 'with the multiplexing of several targets, the resulting price per target is actually low.'

根特大学的Trypsteen还表示，虽然与qPCR相比，dPCR的单个样本成本常被认为是采用的一个障碍，“但通过多个目标的多重分析，每个目标的实际价格其实很低。”

Dx systems, IVD tests

Dx系统，IVD测试

Despite these potential advantages, dPCR has been making inroads into clinical oncology at a very measured pace. Prior to being acquired by Bio-Rad, digital PCR developer RainDance was working on a BCR-ABL assay to measure leukemia treatment response.

尽管存在这些潜在优势，dPCR 以非常谨慎的步伐在临床肿瘤学领域取得进展。在被 Bio-Rad 收购之前，数字 PCR 开发商 RainDance 正在研究一种 BCR-ABL 检测方法，以测量白血病治疗反应。

Bio-Rad subsequently advanced a test called QXDx BCR-ABL %IS Kit on a dedicated diagnostics-focused instrument, the QXDx. The assays and system were

Bio-Rad随后在一款专注于诊断的专用仪器QXDx上推出了一项名为QXDx BCR-ABL %IS Kit的检测。这些检测和系统 были

CE marked

CE标志

in 2017 and

2017年以及

cleared

已清除

by the US Food and Drug Administration in 2019, with the firm

2019年，美国食品药品监督管理局（FDA）批准，这家公司…

stating

声明

that

那个

obtaining regulatory clearances for liquid biopsy IVD tests was a high priority

获得液体活检IVD测试的监管批准是重中之重。

.

。

Bio-Rad's BCR-ABL remains commercially available in the US and Europe, Kulisch said, adding that last year the firm saw growing demand for it, particularly in Europe following its IVDR registration.

库利施表示，Bio-Rad的BCR-ABL产品在美国和欧洲仍然有售，并补充说去年该公司对该产品的需求不断增长，尤其是在其获得IVDR注册后，欧洲市场的需求尤为明显。

Qiagen joined the dPCR party with the launch of its QiAcuity system in 2020 and last year

2020年，Qiagen推出了QiAcuity系统，加入了dPCR领域，并于去年

asserted

断言

customer interest in oncohematology and companion diagnostics when it

客户对血液肿瘤学和伴随诊断的兴趣所在

debuted

首次亮相

its dedicated diagnostics system, the QiAcuity-Dx. The system has both research-use and IVD modes, and Qiagen said at the time that it would be submitting a BCR-ABL test to the FDA in the second half of 2025.

其专用诊断系统 QiAcuity-Dx。该系统具有研究使用和体外诊断（IVD）两种模式，Qiagen 当时表示将在 2025 年下半年向 FDA 提交 BCR-ABL 测试申请。

Meanwhile, Roche

与此同时，罗氏

launched

已启动

its Digital Light Cycler in 2022 with a dedicated regulated bioanalysis mode, saying at the time it would target the oncology space.

其数字光循环仪于2022年推出，配备了专用的受监管生物分析模式，并当时表示将瞄准肿瘤学领域。

'Roche continues to explore areas and use cases that utilize the strength of digital PCR to advance clinical diagnostic solutions,' a spokesperson for Roche commented in an email. While the firm is continually evaluating high-value medical content for its molecular diagnostic technologies to improve clinical diagnostics, it does not comment on projects in development, the spokesperson said..

罗氏发言人在一封电子邮件中评论道：“罗氏继续探索利用数字PCR优势的领域和用例，以推进临床诊断解决方案。” 该发言人表示，虽然公司正在不断评估其分子诊断技术的高价值医学内容以改善临床诊断，但不会对正在开发中的项目发表评论。

Perhaps indicative of the strategic shifts in the oncology dPCR space, Qiagen has since hit pause on its BCR-ABL assay FDA submission, according to Arnold. Rather, the firm is expanding its portfolio of RUO assays, he said, allowing it to 'respond more quickly to market needs, accelerate customer adoption, and lay the groundwork for future IVD conversions based on real-world demand.'.

也许这表明了肿瘤学dPCR领域的战略转变，根据阿诺德的说法，凯杰（Qiagen）已经暂停了其BCR-ABL检测的FDA提交。相反，该公司正在扩展其仅供研究使用（RUO）的检测组合，他表示，这将使公司“能够更快速地响应市场需求，加速客户采用，并为基于实际需求的未来体外诊断（IVD）转化奠定基础”。

Schade noted that Qiagen continues to pursue FDA approval for a portfolio of diagnostics.

沙德指出，凯杰继续寻求FDA对其诊断产品组合的批准。

'This includes developing IVD-labeled systems and assays, building regulatory infrastructure, and pursuing key FDA and IVDR submissions to bring digital PCR into routine clinical care,' she said, for mutation detection, gene fusions, and copy number variations, and targeting both hematologic and solid tumor indications such as breast cancer..

“这包括开发带有IVD标志的系统和检测方法、建立监管基础设施，以及进行关键的FDA和IVDR申报，以将数字PCR引入常规临床护理，”她说道，用于突变检测、基因融合和拷贝数变异，并针对血液肿瘤和实体瘤适应症，如乳腺癌。

Kulisch, meanwhile, said that Bio-Rad is also developing novel RUOs, such as its recently launched suite of methylation detection assays.

库利施同时表示，Bio-Rad公司还在开发新型RUO产品，例如其最近推出的甲基化检测试剂盒系列。

Last year Bio-Rad launched its ddPLEX ESR1 mutation detection assay that can discriminate and quantify seven gene variants with high sensitivity from formalin-fixed, paraffin-embedded tissue and plasma samples.

去年，Bio-Rad 推出了其 ddPLEX ESR1 突变检测分析方法，该方法能够以高灵敏度从福尔马林固定、石蜡包埋的组织和血浆样本中区分并量化七种基因变异。

Developed with input from researchers at the UK's Institute of Cancer Research, the test can be used to guide treatment for advanced breast cancer. Detecting ESR1 mutations is key to treatment with the Menarini Group's selective estrogen receptor degrader Orserdu (elacestrant), Kulisch noted, while serial monitoring of ESR1 status using plasma circulating tumor DNA has been recommended by the National Comprehensive Cancer Network..

该测试由英国癌症研究所的研究人员提供输入开发，可用于指导晚期乳腺癌的治疗。Kulisch指出，检测ESR1突变是使用美纳里尼集团的选择性雌激素受体降解剂Orserdu（elacestrant）治疗的关键，而国家综合癌症网络推荐使用血浆循环肿瘤DNA对ESR1状态进行连续监测。

Bio-Rad is also developing similar assays aimed at biomarker detection in non-small cell squamous cell lung cancer, breast cancer, and other tumor types, Kulisch said.

库利施说，Bio-Rad 还在开发类似的检测方法，旨在非小细胞鳞状细胞肺癌、乳腺癌和其他肿瘤类型中进行生物标志物检测。

At Thermo Fisher, Eron said the goal is to provide customers with reliable, precise tools and to ensure solutions comply with regulatory requirements in respective jurisdictions. Its Absolute Q digital PCR system supports the firm's TaqMan assays as well as third-party dPCR kits, and many third-party assay developers already provide kits for Absolute Q, according to Eron..

在赛默飞世尔，埃隆表示，目标是为客户提供可靠、精确的工具，并确保解决方案符合各自司法管辖区的监管要求。据埃隆介绍，其Absolute Q数字PCR系统支持该公司的TaqMan检测以及第三方dPCR试剂盒，许多第三方检测开发者已经提供适用于Absolute Q的试剂盒。

Support and collaboration

支持与协作

Besides nurturing relationships with clinical researchers, Bio-Rad, Qiagen, and Thermo Fisher support molecular kit makers.

除了培养与临床研究人员的关系外，Bio-Rad、Qiagen 和 Thermo Fisher 还支持分子试剂盒制造商。

Kulisch noted that Bio-Rad is collaborating with Allegheny Health Network and the department of molecular medicine at Aarhus University Hospital in Denmark to generate clinical evidence for MRD monitoring post curative-intent treatment in patients with solid-tumor cancers.

库利施指出，Bio-Rad正在与阿勒格尼健康网络以及丹麦奥胡斯大学医院分子医学系合作，为接受治愈性治疗后的实体瘤癌症患者生成MRD监测的临床证据。

Biodesix has 'a strong working relationship with Bio-Rad,' Pestano said, with the two firms collaborating on development of ddPCR-based MRD assays as well as clinical trials at MSKCC.

佩斯塔诺表示，Biodesix与Bio-Rad“有着良好的合作关系”，两家公司正在合作开发基于ddPCR的MRD检测方法，并在MSKCC进行临床试验。

Bio-Rad also recently invested in

Bio-Rad最近还投资了

Geneoscopy

基因镜检查

and its ddPCR-based ColoSense colorectal cancer test, which was cleared by the FDA last year and is now offered in commercial partnership by the Laboratory Corporation of America. An EGFR assay for non-small cell lung cancer from Gencurix, a member of Bio-Rad's licensed kit provider program, was recently adopted by Samsung Seoul Hospital, Kulisch said, and Gencurix continues assay development for NSCLC, CRC, melanoma, and thyroid and endometrial cancers.

其基于ddPCR的ColoSense结直肠癌检测于去年获得FDA批准，现在由美国实验室公司（Laboratory Corporation of America）进行商业合作提供。Bio-Rad授权试剂盒供应商计划成员Gencurix开发的非小细胞肺癌EGFR检测最近被三星首尔医院采用，库利施表示，Gencurix继续针对非小细胞肺癌、结直肠癌、黑色素瘤以及甲状腺和子宫内膜癌进行检测开发。

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Bio-Rad's pending acquisition of Stilla and its Nio family of automated digital PCR systems is expected to complement its existing portfolio and accelerate the development of digital PCR solutions, including for clinical oncology applications, according to Kulisch.

库利施表示，Bio-Rad计划收购Stilla及其Nio系列自动数字PCR系统，预计将完善其现有产品组合，并加速数字PCR解决方案的开发，包括用于临床肿瘤学应用的解决方案。

As part of Qiagen's strategic approach, Arnold said the firm also collaborates with select third-party developers to expand the ecosystem around digital PCR in clinical oncology.

作为凯杰战略方法的一部分，阿诺德表示，该公司还与精选的第三方开发者合作，以扩大数字PCR在临床肿瘤学领域的生态系统。

'These partnerships, which include pharma, diagnostics, and clinical laboratory companies, allow us to complement our own assay pipeline and give customers broader access to clinically validated solutions,' he said.

“这些合作伙伴关系包括制药、诊断和临床实验室公司，使我们能够完善我们自己的检测流程，并让客户更广泛地获得经过临床验证的解决方案，”他说道。

Examples of collaboration areas include companion diagnostics, laboratory-developed test content, and regional assay providers that align with the firm's regulatory and quality standards. A recent example, albeit in the infectious disease space, might be Qiagen's support of researchers at Brown University Health's Rhode Island Hospital who are .

协作领域的例子包括伴随诊断、实验室开发的测试内容以及符合公司监管和质量标准的区域性检测供应商。最近的一个例子，尽管是在传染病领域，可能是凯杰（Qiagen）对布朗大学健康中心罗德岛医院研究人员的支持，他们正在。。

developing

开发

a blood-based pathogen RNA test for pneumonia on the QiAcuity-Dx system.

基于血液的病原体RNA检测，用于QiAcuity-Dx系统上的肺炎检测。

Kit makers and service providers are also keeping an open approach to dPCR system partners.

试剂盒制造商和服务提供商也对数字PCR系统合作伙伴保持开放的态度。

GT Molecular's McKee said his firm has developed assays for a host of qPCR and dPCR systems using its proprietary chemistries for ultrasensitive, multitarget detection. Within dPCR, GT Molecular has assays for Bio-Rad's QX200 and QX600, Thermo Fisher's Absolute Q, Roche's Digital Light Cycler, and Qiagen's QiAcuity, and it often collaborates with platform manufacturers to ensure optimized performance and ease of use.

GT Molecular的麦基表示，他的公司已经利用其专有的化学技术为众多qPCR和dPCR系统开发了检测方法，实现了超灵敏、多靶点检测。在dPCR领域，GT Molecular为Bio-Rad的QX200和QX600、Thermo Fisher的Absolute Q、罗氏的Digital Light Cycler以及Qiagen的QiAcuity开发了检测方法，并且经常与平台制造商合作，以确保优化性能和使用便捷性。

This enables its assay development teams to be 'especially responsive to market demands and custom requests from our commercial and government partners.'.

这使其分析开发团队“能够特别响应市场需求以及来自我们商业和政府合作伙伴的定制请求。”

Toward the future

面向未来

Ultimately, enabling clinicians to more effectively tailor cancer care in the future may necessitate marrying dPCR with other approaches.

最终，要使临床医生在未来更有效地调整治疗方案，可能需要将数字PCR与其他方法结合起来。

For example, Eron said Thermo Fisher leverages its qPCR and NGS capabilities to offer combined solutions, 'as these complementary technologies address different use cases in clinical oncology.' The firm also offers custom assay design capabilities for clinical oncology and recently launched its Applied Biosystems dPCR Universal Master Mix to enable porting of any of 21 million qPCR TaqMan assays to the Absolute Q..

例如，埃隆表示，赛默飞世尔利用其qPCR和NGS能力提供组合解决方案，“因为这些互补技术满足了临床肿瘤学中不同的使用需求。”该公司还提供针对临床肿瘤学的定制检测设计服务，并最近推出了其Applied Biosystems dPCR通用预混液，以便将任何2100万个qPCR TaqMan检测转移到Absolute Q平台。

'By leveraging our comprehensive suite of solutions, including qPCR, NGS, and dPCR, we provide a complete ecosystem of solutions designed to streamline workflows,' Eron said.

“通过利用我们包括qPCR、NGS和dPCR在内的全面解决方案套件，我们提供了一个旨在简化工作流程的完整解决方案生态系统，”埃隆表示。

Similarly, Arnold said that dPCR enhances Qiagen's companion diagnostics offering for pharma, 'where we provide a full suite of molecular testing technologies — qPCR, dPCR, multiplexing, and NGS — across all sample types, from FFPE to plasma.'

同样，阿诺德表示，数字PCR增强了凯杰公司为制药公司提供的伴随诊断产品，“我们提供全套的分子检测技术——qPCR、dPCR、多重分析和NGS——涵盖所有样本类型，从石蜡包埋组织到血浆。”

At the DIGPCR labs, Trypsteen and colleagues are working with the Ghent University spinout Pxlence and contract research organization CellCarta on a dPCR workflow for mutation detection and MRD monitoring after treatment of adult and childhood cancers, which involves sequencing the tumor and developing patient-specific assays.

在DIGPCR实验室，特里普斯廷及其同事正与根特大学的衍生公司Pxlence以及合同研究组织CellCarta合作，开发一种用于突变检测和治疗成人及儿童癌症后的MRD监测的dPCR工作流程，该流程涉及对肿瘤进行测序并开发患者特异性检测方法。

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Naveris has also recently shown its blood-based fragmentomics assay for detecting gynecologic cancers, NavDx+Gyn, is sensitive and specific across 14 high-risk HPV strains associated with these cancers. Gupta said the firm is looking into Codetta Bio's multiomic biomarker measurement platform and is in dialogue with Qiagen about its fully integrated digital PCR platform..

Naveris最近还展示了其基于血液的片段组学检测方法NavDx+Gyn，该方法对与这些癌症相关的14种高危HPV毒株具有敏感性和特异性。Gupta表示，该公司正在研究Codetta Bio的多组学生物标志物测量平台，并且正在与Qiagen就其完全集成的数字PCR平台进行对话。

Though the company may be open to different vendors and complementary analyses, Naveris is partial to dPCR for its current uses.

尽管该公司可能对不同的供应商和互补分析持开放态度，但Naveris目前更倾向于使用dPCR。

To Gupta, digital PCR (dPCR), particularly droplet digital PCR (ddPCR), plays a critical role in HPV-related cancer testing due to its exceptional sensitivity and specificity — especially in low-abundance samples where accurate detection of single viral DNA molecules is essential.

对古普塔而言，数字PCR（dPCR），尤其是液滴数字PCR（ddPCR），在HPV相关癌症检测中发挥着关键作用，因为它具有卓越的灵敏度和特异性，特别是在低丰度样本中，准确检测单个病毒DNA分子至关重要。

Compared to qPCR, ddPCR offers absolute quantification without reliance on standard curves, Gupta said.

古普塔说，与qPCR相比，ddPCR提供了不依赖标准曲线的绝对定量。

Naveris also evaluated both dPCR and Illumina sequencing-based approaches when initially developing NavDx and determined that dPCR's single-molecule detection and absolute quantification offered 'far superior performance' for detecting tumor-derived DNA, particularly in low-abundance blood samples. .

Naveris在最初开发NavDx时还评估了dPCR和基于Illumina测序的方法，并确定dPCR的单分子检测和绝对定量在检测肿瘤来源DNA方面提供了“远远优越的性能”，尤其是在低丰度血液样本中。

'This is exactly the clinical context in which high sensitivity and specificity are critical: patients with low tumor burden, where the test must be both precise and reliable to provide meaningful clinical utility and patient benefit,' he said.

“这正是高灵敏度和特异性至关重要的临床环境：肿瘤负荷较低的患者，检测必须既精确又可靠，才能提供有意义的临床效用和患者受益，”他说。

At Biodesix, the GeneStrat ddPCR tests offered as a service have been major parts of the firm's portfolio for rare variant testing in lung oncology.

在Biodesix，作为服务提供的GeneStrat ddPCR检测已成为该公司在肺癌罕见变异检测领域产品组合中的重要组成部分。

For its Nodify and IQ Lung tests, Biodesix uses Tecan's high-throughput ELISA and LC/MS/MS from Thermo and Agilent Technologies, Pestano said, while Bio-Rad's ddPCR, Thermo's amplicon-based NGS, and Bruker's MALDI-TOF underpin its GeneStrat targeted, GeneStrat NGS, and VeriStrat tests, respectively..

Biodesix公司对其Nodify和IQ Lung测试使用了Tecan的高通量ELISA以及来自Thermo和Agilent Technologies的LC/MS/MS，Pestano表示，而Bio-Rad的ddPCR、Thermo基于扩增子的NGS以及Bruker的MALDI-TOF分别是其GeneStrat靶向测试、GeneStrat NGS和VeriStrat测试的基础。

Importantly, its new assay development and clinical trial services also feature dPCR tests. 'The regulatory framework we have built, and the molecular monitoring aspect of dPCR, are highly sought after qualities of our offering,' Pestano said, adding that the firm expects to see its clinical trial services evolve into companion diagnostic tests in its GeneStrat portfolio..

重要的是，其新的检测开发和临床试验服务也包括数字PCR测试。佩斯塔诺表示：“我们构建的监管框架以及数字PCR的分子监测方面是我们产品中备受追捧的特性。”他补充说，该公司预计其临床试验服务将演变为GeneStrat产品组合中的伴随诊断测试。

The firm's goal is 'to utilize the most robust technologies for the clinical question at hand,' he added. As a result, in strategic relationships, Biodesix continues to evaluate technologies that may be used in all of its laboratory workflows, he said.

他补充说，公司的目标是“为当前的临床问题利用最强大的技术。” 他说，因此，在战略合作关系中，Biodesix继续评估可能用于其所有实验室工作流程的技术。

Meanwhile, Qiagen has a goal to triple its QiAcuity digital PCR business from $90 million in sales in 2023 to $250 million in 2028. As precision medicine advances, Qiagen expects routine adoption of dPCR to grow significantly, Arnold said.

同时，Qiagen 的目标是将其 QiAcuity 数字 PCR 业务的销售额从 2023 年的 9000 万美元增加到 2028 年的 2.5 亿美元。Arnold 表示，随着精准医疗的进步，Qiagen 预计数字 PCR 的常规应用将显著增长。

'We see digital PCR as a vital component of the future of precision oncology, and we're committed to making that future a reality,' he said.

“我们认为数字PCR是精准肿瘤学未来的重要组成部分，我们致力于将这一未来变为现实，”他说。