NEW YORK – Xgenera, a Southampton, UK-based molecular diagnostics startup, has received two government grants to help develop a microRNA-based test for detecting cancer, including the ability to identify the site of origin, into a viable commercial product.

纽约-Xgeneras是一家总部位于英国南安普敦的分子诊断初创公司，已获得两项政府拨款，以帮助开发基于microRNA的癌症检测测试，包括识别起源地的能力，使其成为可行的商业产品。

CEO Andy Shapanis said that Xgenera has received a £2.5 million ($3.3 million) grant from the UK National Institute for Health and Care Research to support development of its Mionco-Dx Test. Xgenera also received a £100,000 grant through Innovate UK's Cancer Therapeutics program, which awarded a total of £12 million in September..

首席执行官安迪·沙帕尼斯（AndyShapanis）表示，Xgeneras已获得英国国家卫生与保健研究所（National Institute for Health and Care Research）250万英镑（330万美元）的资助，以支持其Mionco Dx测试的开发。Xgeneras还通过Innovate UK的癌症治疗计划获得了10万英镑的赠款，该计划于9月共授予1200万英镑。。

According to Shapanis, Xgenera also last month closed a round of seed financing worth £500,000 and commenced a partnership with YouSeq, a UK technology firm based in nearby Winchester that specializes in the manufacture of next-generation sequencing and quantitative PCR kits. As part of its agreement with YouSeq, the company will also gain access to office and laboratory space, he said..

据Shapanis称，Xgeneras上个月还完成了一轮价值50万英镑的种子融资，并开始与YouSeq合作，YouSeq是一家位于附近温彻斯特的英国技术公司，专门生产下一代测序和定量PCR试剂盒。他说，作为与YouSeq协议的一部分，该公司还将获得办公和实验室空间。。

'They are supporting us in getting the best qPCR assay possible,' Shapanis.

“他们正在支持我们获得最好的qPCR检测方法，”Shapanis说。

With the funds from the government grants and financing, plus the new partnership, the year-old company is progressing with its plans to move its multicancer early detection test to a qPCR platform, so that it can be validated in a new cohort and, ultimately, made available for clinical use. The test, he said, was developed with array data, but qPCR is the optimal platform..

在政府拨款和融资以及新伙伴关系的资助下，这家成立多年的公司正在计划将其多癌早期检测测试转移到qPCR平台，以便可以在新的队列中进行验证，并最终用于临床。他说，该测试是用阵列数据开发的，但qPCR是最佳平台。。

'qPCR is more ubiquitous than microarray,' said Shapanis. 'It's cheaper, faster, easier.'

夏帕尼斯说：“qPCR比微阵列更普遍。”它更便宜、更快、更容易。”

It also might give the bantamweight firm an advantage against bigger players like Grail. The UK National Health Service is currently assessing Grail's next-generation sequencing-based Galleri test in a three-year prospective trial involving 140,000 people. The trial is set to finish in 2026, at which time the NHS will decide on implementing Galleri throughout the nation's health system..

这也可能使bantamweight公司在与Grail等更大的公司竞争时拥有优势。英国国家卫生服务局目前正在评估Grail的下一代基于测序的Galleri测试，该测试为期三年，涉及14万人。该试验定于2026年完成，届时NHS将决定在全国卫生系统中实施Galleri。。

'qPCR is orders of magnitude cheaper than next-generation sequencing,' remarked Shapanis. While it's unclear how much the Galleri test will cost when and if it is made available in the UK, the list price is $949 for the test, which Grail said is able to detect more than 50 forms of cancer at an early stage from a blood sample..

“qPCR比下一代测序便宜几个数量级，”Shapanis说。虽然目前尚不清楚加莱里测试在英国上市时的价格，但该测试的标价为949美元，格雷尔表示，该测试能够从血液样本中早期检测出50多种癌症。。

'Nine $50 PCR tests are still cheaper than an NGS test,' said Shapanis. 'qPCR is also easier to adopt, as everyone knows how to run it, and it doesn't require the bioinformatics downstream.'

夏帕尼斯说，9次50美元的PCR检测仍然比NGS检测便宜qPCR也更容易采用，因为每个人都知道如何运行它，并且不需要下游的生物信息学。”

For Shapanis, transferring Xgenera's marker panel to qPCR will be the latest move in an ongoing story that began with his work as a senior research fellow at the University of Southampton, where he earned a Ph.D. in 2019 in oncology and cancer biology. A self-described computational biologist by trade, he originally looked at crafting a protein-based assay to tackle the problem of diagnosing cancer early in asymptomatic patients and providing information on the site of origin with the same test..

对于Shapanis来说，将Xgeneris的标记小组转移到qPCR将是一个正在进行的故事中的最新举措，这个故事始于他在南安普顿大学担任高级研究员的工作，2019年他在那里获得了肿瘤学和癌症生物学博士学位。作为trade自称的计算生物学家，他最初着眼于设计一种基于蛋白质的检测方法，以解决无症状患者早期诊断癌症的问题，并通过相同的检测提供起源地的信息。。

He said the resulting assay worked well but was noisy, which made him turn toward transcriptomics, which has its own pitfalls.

他说，由此产生的检测效果很好，但噪音很大，这使他转向转录组学，这有其自身的缺陷。

'With proteins, there are hundreds of thousands of them, but each one has different versions,' said Shapanis. 'There's a lot of noise to get lost in.' He noted that at the genomic level, an alternation is not always predictive of disease. This led him to search for an 'in-between balance,' somewhere between high and low resolution.

夏帕尼斯说：“蛋白质有几十万种，但每种都有不同的版本。”他指出，在基因组水平上，交替并不总是能预测疾病。这使他在高分辨率和低分辨率之间寻找“中间平衡”。

He found this sweet spot with miRNAs..

他发现了miRNA的这个甜点。。

Shapanis also amassed a set of array data on some 21,000 individuals and used this cohort to select 50 miRNA markers that he found to be predictive for certain cancers, as well as to provide site of origin information. Currently, Xgenera claims its test can detect at early stage the 12 most common cancers — lung, breast, prostate, pancreatic, colorectal, ovarian, liver, brain, esophageal, bladder, bone and soft tissue sarcoma, and gastric..

Shapanis还收集了大约21000个人的一组阵列数据，并使用该队列选择了50个miRNA标记，他发现这些标记可以预测某些癌症，并提供了起源位点信息。目前，Xgenerics声称其测试可以在早期检测12种最常见的癌症-肺癌，乳腺癌，前列腺癌，胰腺癌，结直肠癌，卵巢癌，肝癌，脑癌，食道癌，膀胱癌，骨和软组织肉瘤以及胃癌。。

Paired with in-house-developed machine learning tools, the miRNA classifier, which also includes five controls for a total set of 55 markers, forms the basis of the Mionco test.

miRNA分类器与内部开发的机器学习工具相结合，它还包括五个对照，总共55个标记，构成了Mionco测试的基础。

Shapanis initially considered publishing his findings, but was encouraged by Paul Skipp, a professor of proteomics and director of the Centre for Proteomic Research at the University of Southampton, to explore a commercial route. Skipp is also the founder and director of TopMD Precision Medicine, an artificial intelligence company focused on identifying biomarkers for diagnosing disease and informing treatment.

沙帕尼斯最初考虑发表他的研究结果，但受到南安普顿大学蛋白质组学教授兼蛋白质组学研究中心主任保罗·斯基普的鼓励，他探索了一条商业途径。Skip还是TopMD Precision Medicine的创始人和董事，TopMD Precision Medicine是一家人工智能公司，专注于识别用于诊断疾病和告知治疗的生物标志物。

He is also now a founder and CSO at Xgenera..

他现在也是Xgeneras的创始人和CSO。。

'He's been pivotal in helping me turn this into something,' Shapanis said of Skipp.

夏帕尼斯谈到斯基普时说：“他在帮助我把这件事变为现实方面发挥了关键作用。”。

The company now wants to move the Mionco test to qPCR. This will be accomplished with the £2.5 million grant from the National Institute for Health and Care Research. The project, which commenced this month, is about getting the test into the new format and improving its turnaround time. 'We call it optimization of scalability,' said Shapanis, adding that Xgenera will focus on reducing cost, increasing throughput, and streamlining adoption during the process.

该公司现在想将Mionco测试转移到qPCR。这将通过国家卫生与保健研究所250万英镑的拨款来实现。该项目于本月开始，旨在使测试采用新的格式，并改进其周转时间。”Shapanis说，我们称之为可扩展性优化，并补充说Xgeneras将专注于降低成本，提高吞吐量，并在此过程中简化采用。

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Xgenera will also validate the test in another 8,000 samples as part of the effort. These samples will be drawn from other studies. 'There are many studies with relevant samples out there,' he said. 'We're going to utilize those so we don't have to do prospective collection,' he said.

Xgenerics还将在另外8000个样本中验证该测试。他说，有许多相关样本的研究他说，我们将利用这些资源，这样就不必进行前瞻性收集。

Samples will include those from presymptomatic and asymptomatic patients, he underscored.

他强调，样本将包括症状前和无症状患者的样本。

'We're aiming for a screening test, something that can be used in an asymptomatic population, before they even have clinical symptoms,' Shapanis noted. 'We want to be able to prove, at least in principle, that it can be used in those really early stage patients.'

夏帕尼斯指出：“我们的目标是进行筛查测试，这种测试可以在无症状人群出现临床症状之前使用。”

Xgenera will also be looking to refine its marker set in the process, gauging the performance of each miRNA marker. This could lead to a reduction in the number of markers. Shapanis said that all 50 markers aren't necessary to detect tumor sites of origin, but that a 'layer of redundancy' has been built into Mionco to improve its performance.  .

Xgeneras还将在这个过程中改进其标记集，以衡量每个miRNA标记的性能。这可能导致标记数量的减少。Shapanis说，检测肿瘤起源部位并不需要所有50个标记，但Mionco中已经构建了一层“冗余”来提高其性能。。

The Innovate UK grant, meantime, will be used to support developing new ways of running miRNA analysis on qPCR going forward. Both grants will also allow Xgenera to hire new personnel. These hires will largely be on the R&D side, Shapanis said, as the company looks to add molecular biologists, bioinformaticians, and technicians.

与此同时，Innovate UK赠款将用于支持开发在qPCR上运行miRNA分析的新方法。这两项拨款还将允许Xgeneras雇用新人员。Shapanis说，这些员工将主要在研发方面，因为该公司希望增加分子生物学家、生物信息学家和技术人员。

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The price of the test is still to be determined, and while some recent UK news articles cited a price tag of between £120 and £300 for Mionco, Shapanis said such projections are premature.

测试的价格仍有待确定，虽然最近一些英国新闻报道称Mionco的价格在120英镑至300英镑之间，但Shapanis表示，这样的预测为时过早。

He declined to price the test. 'We're still early in the development process,' he noted. 'What I can say is that we are trying to make it as affordable as possible to make it as accessible to as many people as possible.'

他拒绝为测试定价我能说的是，我们正在努力使尽可能多的人能够负担得起

By the end of the NIHCR grant in three years, the company intends to have a 'final locked product' in place for which it will seek both UKCA marking and CE-IVD certificates under the EU's In Vitro Diagnostic Regulation, Shapanis said. Xgenera is also considering doing a large-scale prospective clinical trial of its test, similar to what Grail is currently doing with the Galleri test..

夏帕尼斯说，到三年后NIHCR拨款结束时，该公司打算推出一种“最终锁定产品”，并将根据欧盟的体外诊断法规寻求UKCA标记和CE-IVD证书。Xgeneris也在考虑对其测试进行大规模的前瞻性临床试验，类似于Grail目前正在进行的Galleri测试。。

The test itself may undergo future updates. Skipp said in an email that 'most certainly the plan is to extend the number of cancers, though this will naturally require further work and validation.' Xgenera also sees an opportunity to extend its platform to monitoring minimal residual disease in response to therapeutic interventions, he said..

测试本身可能会在未来进行更新。斯基普在一封电子邮件中说，“最确定的计划是扩大癌症的数量，尽管这自然需要进一步的工作和验证。”他说，Xgeneras还看到了一个机会，可以将其平台扩展到监测最小残留疾病，以应对治疗干预措施。。