NEW YORK – Qiagen expects a new digital PCR partnership program to help build out its

纽约——凯杰预计一个新的数字PCR合作计划将有助于其扩展。

in vitro

体外

diagnostic menu for the QiAcuityDx clinical digital PCR system.

QiAcuityDx 临床数字 PCR 系统的诊断菜单。

Although Qiagen officially

尽管凯杰官方

announced

宣布

its inaugural partner in Gencurix last week, the firm has been actively recruiting and building a potential pipeline of partners among diagnostic developers and academic medical centers for the past 12 months, according to Huw Ricketts, Qiagen's senior director of CLIA lab business development based in Manchester, UK..

据英国曼彻斯特Qiagen公司CLIA实验室业务发展高级总监胡威·里基茨称，自上周在Gencurix的首个合作伙伴关系达成以来，该公司在过去12个月中一直在积极招募并与诊断开发人员和学术医疗中心建立潜在的合作伙伴关系。

Qiagen launched its QiAcuity system in 2019 and has attained approximately 2,700 instrument placements in the ensuing five years. Its QiAcuityDx clinical system, meanwhile,

Qiagen于2019年推出了QiAcuity系统，并在随后的五年内实现了大约2700台仪器的安装。与此同时，其QiAcuityDx临床系统，

debuted

首次亮相

in the third quarter of 2024.

2024年第三季度。

Now, 'we want to open this up to a wider community,' Ricketts said. 'We can’t develop [assays for] every disease on our own, so we want to take advantage of the ability of partners to be nimble. This will accelerate the development of innovative digital PCR assays and ultimately help more patients.'.

“现在，我们希望将其开放给更广泛的社区，”里基茨说。“我们无法独自开发[针对]每种疾病的检测方法，因此我们希望利用合作伙伴的灵活性。这将加速创新数字PCR检测的开发，并最终帮助更多患者。”

In addition to the QiAcuityDx, there are other dual mode dPCR instruments that run regulated

除了QiAcuityDx之外，还有其他运行受监管的双模式dPCR仪器。

in vitro

体外

diagnostics as well as laboratory-developed tests. Bio-Rad Laboratories'

诊断以及实验室开发的测试。Bio-Rad Laboratories的

QXDx

QXDx

was cleared by the US Food and Drug Administration in 2019, for example, followed by the Roche

例如，2019年获得美国食品和药物管理局批准，随后是罗氏公司

Digital LightCycler

数字光循环仪

in 2022. Other dPCR systems vying for a spot in the clinical lab include the Stilla

2022年，其他争取在临床实验室中占有一席之地的dPCR系统包括Stilla。

Nio+

蔚来+

(a company in the

（一家公司

process

过程

of being bought by Bio-Rad) and the Thermo Fisher Scientific

被Bio-Rad收购）以及赛默飞世尔科技公司

Absolute Q

绝对Q

. Dual-use

. 双重用途

qPCR systems

qPCR系统

for clinical molecular diagnostic testing from Roche and Becton Dickinson also use software with an open utility channel and a diagnostic channel.

用于临床分子诊断测试的罗氏和贝克顿迪金森公司的产品也使用带有开放实用通道和诊断通道的软件。

'This [software] allows labs to use IVD assays from Qiagen and our partners in the Dx channel and still develop their own assays in the utility channel,' Ricketts said, adding that this strategy also reduces the disruption core software updates can sometimes cause to IVD assays.

“这款[软件]允许实验室在Dx渠道中使用来自Qiagen及其合作伙伴的IVD检测，同时仍在实用渠道中开发自己的检测方法，”里基茨表示，并补充说该策略还能减少核心软件更新有时对IVD检测造成的干扰。

Digital PCR is known to be less expensive than sequencing while being more

数字PCR比测序便宜，同时更加

precise

精确的

than standard qPCR. In the past, the cost of dPCR compared to qPCR has been an issue for labs, but Ricketts said that is changing.

比标准的qPCR更贵。过去，dPCR相对于qPCR的成本一直是实验室的一个问题，但里基茨表示这一情况正在改变。

'The difference used to be huge, but it is coming down now,' he said, noting that plate-based dPCR approaches in particular are currently not dramatically more expensive than qPCR testing.

“差别曾经很大，但现在正在缩小，”他说，并指出基于平板的dPCR方法目前并不比qPCR测试昂贵太多。

The potential for high multiplexing in qPCR had also been seen as an advantage, but recent

qPCR中高多重检测的潜力也被视为一种优势，但最近

additions

添加物

of fluorescence channels to dPCR instruments and novel chemistry coupled with deconvolution approaches have increased the number of targets that can be detected per droplet to the high single digits and beyond.

荧光通道与数字PCR仪器和新型化学方法结合解卷积技术，使得每个液滴中可检测到的目标数量增加到接近两位数甚至更多。

All of this means that the adoption of dPCR could be poised for a massive tick up in the coming years, including for diagnostic applications.

所有这一切都意味着，dPCR的采用可能在未来几年内大幅增加，包括在诊断应用方面。

Still in the initial stages of global rollout for QiAcuityDx, Qiagen is currently focused on driving adoption in the EU, US, and Japan, Ricketts said. 'Now we need to deliver content in the IVD channel, which is why third-party partnerships are so important,' he said.

Ricketts 表示，Qiagen 目前仍处于 QiAcuityDx 全球推广的初期阶段，现阶段的重点是推动其在欧盟、美国和日本的采用。他说：“现在我们需要在 IVD 渠道中提供内容，这就是为什么第三方合作如此重要。”

'The program is designed to be flexible and offer a tailored software approach that align with the specific partner’s needs. We are giving our partners support with assay design and optimization of validation studies — again drawing on our vast experience in assay development with partners.'

“该计划旨在提供灵活且定制的软件方法，以满足特定合作伙伴的需求。我们正在为合作伙伴提供检测设计支持和验证研究的优化 —— 再次利用我们在与合作伙伴进行检测开发方面的丰富经验。”

Although the firm is branding the QiAcuityDx as the QiAcuityDx Four in some of its communications, Ricketts said this is to denote that the system can process four plate-based consumables simultaneously and they are the same system.

尽管该公司在某些沟通中将 QiAcuityDx 品牌称为 QiAcuityDx Four，但 Ricketts 表示，这是为了表示该系统可以同时处理四个基于板的耗材，它们是同一系统。

Notable Dx system placements so far have included Christie NHS Foundation Trust in Manchester, UK, and Tracer Biotechnologies, Ricketts said.

到目前为止，显著的Dx系统部署包括英国曼彻斯特的克里斯蒂NHS基金会信托和特雷瑟生物技术公司，里基茨说。

'The Christie is a world-renowned cancer hospital, and we have been working with them to develop and test cancer biomarkers for use in liquid biopsy,' he said. At the European Association for Cancer Research meeting in Lisbon, Portugal, last week, researchers presented a poster showing the QiAcuityDx can be used to track biomarkers, such as KRAS and EGFR in liquid biopsy samples of non-small cell lung cancer patients for treatment response monitoring..

“克里斯蒂医院是一家世界知名的癌症医院，我们一直与他们合作开发和测试用于液体活检的癌症生物标志物，”他说道。在上周于葡萄牙里斯本举行的欧洲癌症研究协会会议上，研究人员展示了一张海报，显示 QiAcuityDx 可用于追踪非小细胞肺癌患者液体活检样本中的生物标志物（如 KRAS 和 EGFR），以监测治疗反应。

Qiagen announced a partnership with Tracer Biotechnologies during the American Society of Clinical Oncology meeting earlier this month. Currently research-use only, Tracer is developing personalized minimum residual disease assays on for scalable, sensitive, precise, and cost-effective treatment response monitoring.

本月早些时候，在美国临床肿瘤学会会议期间，Qiagen宣布与Tracer Biotechnologies达成合作伙伴关系。目前仅用于研究，Tracer正在开发个性化的微小残留病检测方法，以实现可扩展、灵敏、精确且具有成本效益的治疗反应监测。

.

。

Ricketts said developers like Tracer are appreciating that dPCR offers high precision compared to qPCR without the need to generate calibration curves, as well as the potential to scale up testing. 'It's much cheaper to run a multiplexed digital PCR assay than multiple NGS assays,' he said.

里基茨说，像特雷瑟这样的开发者认为，与qPCR相比，dPCR提供了更高的精确度，且无需生成校准曲线，并具有扩大测试规模的潜力。“运行一个多路复用的数字PCR检测比多个NGS检测要便宜得多，”他说。

Going forward, Qiagen aims to show the clinical utility of this approach in collaboration with its pharma partners, he said.

他说，展望未来，Qiagen旨在与其制药合作伙伴合作，展示这种方法的临床实用性。

The Dx system is considered 510(k) exempt, and Qiagen recently

Dx系统被认为免于510(k)审查，且Qiagen最近

disclosed

披露

that it has paused its efforts on a regulated BCR-ABL assay. However, a large part of Qiagen's Partnering for Precision Diagnostics division — housed within its

其在受监管的BCR-ABL检测方面的工作已暂停。然而，Qiagen的精准诊断合作部门——设在其内部的

newly created

新建的

product portfolio and innovation business unit — has been dedicated to curating partnerships in the companion diagnostics space.

产品组合与创新业务部门——一直致力于在伴随诊断领域策划合作伙伴关系。

Qiagen is now in discussions with multiple global regulatory bodies, including the FDA, and may potentially advance the Dx system and a companion diagnostic test through the 510(k) pathway, Ricketts said.

里基茨说，凯杰目前正在与包括FDA在内的多个全球监管机构进行讨论，可能会通过510(k)途径推进Dx系统和伴随诊断测试。

In addition to oncology testing, Ricketts said Qiagen is hoping partners can help it build a menu for transplant monitoring, as well as infectious and metabolic disease testing.

除了肿瘤学测试，Ricketts表示凯杰希望合作伙伴能帮助其开发移植监测以及传染性疾病和代谢性疾病测试的菜单。

However, 'oncology is a core strength of Qiagen, so we will continue to explore partnerships, internal development, and companion diagnostics for oncology,' he said.

然而，他说：“肿瘤学是Qiagen的核心优势，因此我们将继续探索在肿瘤学领域的合作伙伴关系、内部开发和伴随诊断。”

The firm is in the midst of ongoing discussions with major medical academic centers around developing oncology assays on the QiAcuityDx. 'In Gencurix, we have a partner who has proven expertise in the development of high multiplex digital PCR assays,' he added.

该公司正与主要的医学学术中心进行持续讨论，围绕在QiAcuityDx平台上开发肿瘤学检测方法。他补充道：“在Gencurix，我们有一个在高多重数字PCR检测开发方面具有成熟专业知识的合作伙伴。”

Other novel applications in development for dPCR in the

dPCR在开发中的其他新颖应用包括

clinical space

临床空间

include a pathogen RNA

包含病原体RNA

pneumonia test

肺炎测试

that could potentially also be used for treatment monitoring and a 20-minute assay to map tumor boundaries

可能还用于治疗监测，并用20分钟的检测来绘制肿瘤边界。

during brain surgery

在脑外科手术期间

.

。

Partnering with other developers to generate a menu is not a terribly new approach, but it seems to be gaining in popularity. In point-of-care testing, Cepheid

与其他开发者合作生成菜单并不是一个非常新的方法，但似乎它正在变得越来越流行。在即时检测中，Cepheid

opened

打开

up its GeneXpert for third-party development a few years ago, and Bio-Rad has also had a longstanding partnership program and

几年前，它开放了GeneXpert供第三方开发，Bio-Rad也有一个长期的合作伙伴计划，并且

Gencurix

GenCurix

was also one of its early partners.

也是其早期合作伙伴之一。

Qiagen also has a long history of successful partnering with other Dx companies and pharma for the creation of PCR, digital PCR, and NGS assays, Ricketts said, and the QiAcuityDx system was purpose-built to enable easy and flexible content development.

凯特表示，Qiagen 与其它诊断公司和制药公司在合作创建 PCR、数字 PCR 和 NGS 检测方面也有着悠久的成功历史，而 QiAcuityDx 系统则是专为实现便捷且灵活的内容开发而打造。

'We have talented internal teams working on content development and want to share that strength with others,' he said.

“我们有才华横溢的内部团队负责内容开发，并希望将这一优势与他人分享，”他说道。