NEW YORK – Oxford Nanopore Technologies has been working on a tuberculosis drug resistance sequencing assay that it hopes will become its first in vitro diagnostic test developed in house.

纽约-牛津纳米孔技术公司（Oxford Nanopore Technologies）一直致力于结核病耐药性测序分析，希望这将成为其首次在内部开发的体外诊断测试。

Dubbed Ampore-TB, the assay will enable TB drug resistance profiling directly ​from sputum samples in about six hours using the GridIon platform and an automated analysis pipeline supported by Epi2me, Oxford Nanopore’s cloud-based bioinformatics platform.

这种被称为Ampore TB的检测方法将使结核病产生耐药性 直接分析 ​使用GridIon平台和由牛津纳米孔基于云的生物信息学平台Epi2me支持的自动分析管道，在大约六小时内从痰样本中提取。

An Oxford Nanopore spokesperson told GenomeWeb that Ampore-TB is currently undergoing internal validation and is slated to be released globally as a research-use-only product later this year. The company plans to obtain regulatory approval for the test under the European Union’s In Vitro Diagnostic Regulation and from the US Food and Drug Administration but did not disclose a timeline.

牛津纳米孔公司的一位发言人告诉GenomeWeb，Ampore TB目前正在进行内部验证，预计将于今年晚些时候作为研究专用产品在全球发布。该公司计划根据欧盟体外诊断法规和美国食品和药物管理局（FDA）的规定获得该测试的监管批准，但没有透露时间表。

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The GridIon platform will meet the ISO 13485 standard in 2025, the spokesperson also noted, but that instrument will not be specific to TB testing and will only be available to specified partners.

这位发言人还指出，GridIon平台将在2025年达到ISO 13485标准，但该仪器将不会专门用于结核病检测，只提供给特定的合作伙伴。

According to Emma Stanton, senior VP of clinical at Oxford Nanopore, a major reason for the company to select Ampore-TB as its first prospective IVD test is 'a very clear call to action' from the World Health Organization, which published a new guideline in March recommending the use of targeted next-generation sequencing for the diagnosis of drug-resistant TB.

根据牛津纳米孔公司临床高级副总裁艾玛·斯坦顿（EmmaStanton）的说法，该公司选择Ampore TB作为其第一个前瞻性IVD测试的主要原因是世界卫生组织（World Health Organization）发出了“非常明确的行动呼吁”，该组织于3月发布了一项新的指南，建议使用靶向的下一代测序技术诊断耐药结核病。

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The guideline specifically highlighted Oxford Nanopore’s Ampore-TB, along with the Deeplex Myc-TB test from Genoscreen in France and the Tbseq assay from Hangzhou ShengTing Medical Technology in China.

该指南特别强调了Oxford Nanopore的Ampore TB，以及法国Genoscreen的Deeplex Myc TB测试和中国杭州盛庭医疗科技有限公司的Tbseq检测。

Oxford Nanopore has yet to disclose Ampore-TB’s technical specs. Stanton declined to comment on the final format of the assay, citing the early stage of its development.

Oxford Nanopore尚未披露Ampore TB的技术规格。斯坦顿以其发展的早期阶段为由，拒绝就检测的最终形式发表评论。

According to the WHO’s guideline, Ampore-TB, which analyzes sputum samples, is a targeted NGS test developed for the simultaneous identification of mycobacterial species and the detection of mycobacterium tuberculosis (MTBC) complex genetic variants that have been linked to antimicrobial resistance.

根据世界卫生组织的指南，分析痰样本的Ampore TB是一种有针对性的NGS测试，用于同时鉴定分枝杆菌物种和检测与抗菌药物耐药性相关的结核分枝杆菌（MTBC）复杂遗传变异。

The guideline noted that Ampore-TB has met the performance criteria to profile resistance to rifampicin, isoniazid, fluoroquinolones, linezolid, amikacin, and streptomycin..

该指南指出，Ampore TB已达到描述对利福平，异烟肼，氟喹诺酮类，利奈唑胺，阿米卡星和链霉素耐药性的性能标准。。

The assay sequences 27 amplicons, including 24 drug resistance targets, a genotyping target, a non-tuberculous mycobacteria identification target (hsp65), and an internal control, using the Oxford Nanopore GridIon device.

该测定使用牛津纳米孔网格装置对27个扩增子进行测序，包括24个耐药靶标，基因分型靶标，非结核分枝杆菌鉴定靶标（hsp65）和内部对照。

Additionally, the guideline noted that the Ampore-TB workflow includes pre-installed analysis software that can automatically generate a report of the test results.

此外，指南指出，Ampore TB工作流程包括预装的分析软件，可以自动生成测试结果报告。

Stanton said Ampore-TB is being developed by Oxford Nanopore internally, with some IP licensed from the UK's Quadram Institute, which the company has been collaborating with to develop the workflow. Once the test is ready, Oxford Nanopore plans to leverage its existing partnership with French in vitro diagnostics firm BioMérieux to help roll it out globally, tapping into the partner's logistics network..

斯坦顿说，Ampore TB由牛津纳米孔公司内部开发，部分IP由英国Quadram研究所授权，该公司一直与该研究所合作开发该工作流程。一旦测试准备就绪，牛津纳米孔计划利用其与法国体外诊断公司BioMérieux的现有合作伙伴关系，帮助其在全球范围内推广，并利用合作伙伴的物流网络。。

'[BioMérieux’s] role is in helping us to commercialize and distribute the test, they are not developing the test,' said Stanton. 'Essentially, we will give them the fully developed test, and they will be responsible for distributing it.'

斯坦顿说，“（生物技术研究所）的作用是帮助我们将该测试商业化和分发，他们并没有开发该测试。”从本质上讲，我们将给他们充分开发的测试，他们将负责分发它。”

'After a year-long partnership with Oxford Nanopore, significant progress has been made towards developing a research use only (RUO) sequencing product for detecting drug resistance in tuberculosis,' Charles Cooper, executive VP and chief medical officer of BioMérieux, wrote in an email. 'This achievement results from an excellent collaboration between the teams involved.

BioMérieux执行副总裁兼首席医疗官查尔斯·库珀（CharlesCooper）在一封电子邮件中写道：“与牛津纳米孔公司（Oxford Nanopore）合作一年后，在开发用于检测结核病耐药性的研究用途（RUO）测序产品方面取得了重大进展。”这一成就源于相关团队之间的出色合作。

It marks an important milestone in the development of an in vitro diagnostic (IVD) test.'.

它标志着体外诊断（IVD）测试发展的一个重要里程碑。”。

While Cooper’s statement appears to suggest BioMérieux is involved in the development of Ampore-TB, an Oxford Nanopore spokesperson confirmed that the test is completely developed in house by the company. The spokesperson also said BioMérieux is 'sharing their indispensable experience on infectious disease diagnostics' with Oxford Nanopore..

虽然库珀的声明似乎表明BioMérieux参与了Ampore TB的开发，但牛津纳米孔公司的发言人证实，该测试完全是由该公司内部开发的。这位发言人还表示，BioMérieux正在与牛津纳米孔公司“分享他们在传染病诊断方面不可或缺的经验”。。

Stanton said Oxford Nanopore will have to get regulatory approval from each of the countries it plans to sell Ampore-TB in. The goal is to launch the test in waves, she said, and her team has already begun conversations with regulatory authorities of those countries where the test will first become available.

斯坦顿说，牛津纳米孔必须获得其计划销售Ampore结核病的每个国家的监管部门批准。她说，目标是一波接一波地启动这项测试，她的团队已经开始与那些测试将首先提供的国家的监管机构进行对话。

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She did not disclose the names of those countries and did not comment on Oxford Nanopore's plans for regulatory approvals in low- and middle-income countries, where TB testing is in highest demand.

她没有透露这些国家的名称，也没有评论牛津纳米孔公司（Oxford Nanopore）在中低收入国家获得监管批准的计划，因为这些国家对结核病检测的需求最高。

Ampore-TB is not the only sequencing-based TB test highlighted by the WHO. The TBseq test from China’s Hangzhou ShengTing Medical Technology, for instance, also uses the Oxford Nanopore MinIon or GridIon platform. Meanwhile, Genoscreen’s Deeplex Myc-TB can be performed using the Nextera XT and DNA lex library preparation kits and the Illumina iSeq 100, MiniSeq, MiSeq, or NextSeq sequencers, according to the guidelines.

Ampore结核病并不是世卫组织强调的唯一基于测序的结核病检测。例如，中国杭州盛庭医疗科技有限公司的TBseq测试也使用了牛津纳米孔MinIon或GridIon平台。同时，根据指南，Genoscreen的Deeplex Myc TB可以使用Nextera XT和DNA lex文库制备试剂盒以及Illumina iSeq 100，MiniSeq，MiSeq或NextSeq测序仪进行。

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Besides the advantages of nanopore sequencing forTB testing, such as its fast turnaround time and accessibility, the WHO guideline also pointed out some 'feasibility challenges' for the technology, including library preparation being 'quite complex' and 'the need for improved computer analysis and storage capacity.'.

除了纳米孔测序forTB测试的优点（例如快速周转时间和可访问性）外，WHO指南还指出了该技术的一些“可行性挑战”，包括文库制备“相当复杂”以及“需要改进计算机分析和存储容量”。

Beyond targeted NGS, WHO’s guideline also highlighted various other molecular technologies for rapid TB diagnosis and resistance detection, including moderate-complexity automated nucleic acid amplification technologies (NAATs) for the detection of TB and resistance to rifampicin and isoniazid, lateral flow antigen detection tests, low-complexity automated NAATs for the detection of resistance to isoniazid and second-line anti-TB agents, and line-probe assays..

除了有针对性的NGS之外，世卫组织的指南还强调了用于快速结核病诊断和耐药性检测的各种其他分子技术，包括用于检测结核病和利福平和异烟肼耐药性的中等复杂度自动核酸扩增技术（NAAT），侧流抗原检测测试，用于检测异烟肼和二线抗结核药物耐药性的低复杂度自动NAAT，以及线探针检测。。

The development of Ampore-TB is spearheaded by Oxford Nanopore Diagnostics, a subsidiary of Oxford Nanopore that was established in 2022 but has largely remained silent since then.

牛津纳米孔诊断公司（Oxford Nanopore Diagnostics）是牛津纳米孔公司（Oxford Nanopore）的子公司，成立于2022年，但自那时以来，该公司一直保持沉默。

'We haven't spoken about [OND] a lot in the public domain,' said Stanton, who heads the subsidiary. While the creation of OND was 'necessary for many legal, contractual, and regulatory requirements,' she said, her team is 'deliberately embedded across in the parent organization' and works closely with the rest of company.

该子公司负责人斯坦顿（Stanton）说，我们在公共领域没有谈论太多。她说，虽然创建OND“对于许多法律、合同和监管要求都是必要的”，但她的团队“故意嵌入到母公司中”，并与公司其他部门密切合作。

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According to Stanton, the OND team includes people working in regulatory affairs and quality assurance. It also has employees with 'domain expertise' across various clinical areas, as well as 'other people who [have] experience from our competitors in taking sequencing platforms into clinical markets,' she added.

据斯坦顿介绍，OND团队包括监管事务和质量保证方面的人员。她补充说，它还拥有在各个临床领域具有“领域专业知识”的员工，以及“其他在将测序平台带入临床市场方面拥有竞争对手经验的人”。

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Beyond its in-house development efforts, Stanton said an integral part of Oxford Nanopore’s clinical strategy is to forge partnerships with other institutions and companies. Although Ampore-TB is on track to become the company’s first own IVD product, infectious disease is 'the smallest target addressable market' for the firm, she said, adding that the company is also eyeing other disease areas such as oncology, transplant diagnostics, as well as rare diseases and other genetic disorders.

斯坦顿表示，除了内部开发工作之外，牛津纳米孔临床战略的一个组成部分是与其他机构和公司建立合作伙伴关系。她说，虽然Ampore TB有望成为该公司第一款自主研发的IVD产品，但传染病是该公司“可瞄准的最小目标市场”，并补充说，该公司还关注其他疾病领域，如肿瘤学、移植诊断学以及罕见病和其他遗传疾病。

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Stanton highlighted a series of clinical partnerships the firm has already forged, such as an agreement with Day Zero Diagnostics to develop a diagnostic solution for sepsis, collaborations with Hungarian firm Omixon and Dutch company GenDx to develop HLA transplant diagnostic tests, and a deal with Swiss manufacturer 4bases to develop tests for BRCA1 and BRCA2 breast and ovarian cancer susceptibility genes.

斯坦顿强调了该公司已经建立的一系列临床合作伙伴关系，例如与Day Zero Diagnostics达成协议，开发脓毒症诊断解决方案，与匈牙利公司Omixon和荷兰公司GenDx合作开发HLA移植诊断测试，以及与瑞士制造商4bases达成协议，开发BRCA1和BRCA2乳腺癌和卵巢癌易感基因测试。

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At its annual user meeting in London this week, Oxford Nanopore is holding a dedicated 'Clinical and Biopharma Day' for the first time that is distinct from the main event, signaling the company’s increasing focus on clinical and applied markets

在本周于伦敦举行的年度用户会议上，牛津纳米孔首次举办了一个专门的“临床和生物制药日”，这与主要活动不同，表明该公司越来越关注临床和应用市场

Still, with Ampore-TB’s IVD timeline unclear, it appears that Oxford Nanopore has a way to go to become a diagnostic test manufacturer.

尽管如此，由于Ampore TB的IVD时间表尚不清楚，牛津纳米孔似乎还有一段路要走，才能成为诊断测试制造商。

'Whilst we are on a path to have diagnostics, this is really about showcasing and sharing where we are [with the technology],' Stanton said. 'It's a Clinical and Biopharma Day, not a Diagnostics Day, quite deliberately.'

斯坦顿说：“虽然我们正在进行诊断，但这实际上是为了展示和分享我们（使用技术）的现状。”这是一个临床和生物制药日，而不是诊断日，这是故意的