NEW YORK – Owlstone Medical has been developing a menu of breath-based tests using parallel approaches to detect in breath endogenous biomarkers of disease and measuring signals produced as the body metabolizes specially prepared solutions.

纽约–Owlstone Medical一直在开发一系列基于呼吸的测试，使用并行方法检测疾病的呼吸内源性生物标志物，并测量身体代谢特殊制备的溶液时产生的信号。

The Cambridge, UK-based firm is closing in on the commercialization of its Libra test that uses a volatile organic compound (VOC) probe for the early detection of liver disease while it conducts clinical trials for its Evolution test that uses a VOC probe for the early detection of lung cancer. Meanwhile, the company recently inked a five-year research agreement with the US Food and Drug Administration to develop tools to identify in breath samples VOCs that could be used in diagnostic tests..

这家总部位于英国剑桥的公司正在接近其Libra测试的商业化，该测试使用挥发性有机化合物（VOC）探针进行肝病的早期检测，同时进行进化测试的临床试验，该测试使用VOC探针进行肺癌的早期检测。与此同时，该公司最近与美国食品和药物管理局签署了一项为期五年的研究协议，以开发识别呼吸样本中挥发性有机化合物的工具，这些挥发性有机化合物可用于诊断测试。。

Owlstone CEO Billy Boyle said that the research collaboration with the FDA will involve the development of methods for identifying individual compounds from breath samples, confirming that those potential biomarkers are exhaled in breath and determining the concentration ranges of those substances in healthy controls.

Owlstone首席执行官比利·博伊尔（BillyBoyle）表示，与FDA的研究合作将涉及开发从呼吸样本中识别单个化合物的方法，确认这些潜在的生物标志物是在呼吸中呼出的，并确定健康对照中这些物质的浓度范围。

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The company recently announced that the work will include the development of a common set of analytical methods that breath researchers could use as a reference and that the expanded use of breath-based testing could increase access to testing in rural and economically challenged areas. The collaboration also includes the development of Owlstone's Breath Biopsy VOC Atlas database of identified and quantified compounds in breath..

该公司最近宣布，这项工作将包括开发一套通用的分析方法，供呼吸研究人员参考，并且扩大使用基于呼吸的测试可以增加农村和经济困难地区的测试机会。该合作还包括开发Owlstone的呼吸活检VOC图谱数据库，该数据库包含已识别和定量的呼吸化合物。。

The FDA said in an email that the agency plans to develop the analytical chemistry methods to identify chemicals in complex gaseous mixtures, including breath samples, using gas chromatography-mass spectrometry (GC-MS). The methods will be publicly available.

FDA在一封电子邮件中表示，该机构计划开发分析化学方法，使用气相色谱-质谱（GC-MS）鉴定复杂气体混合物中的化学物质，包括呼吸样品。这些方法将公开提供。

The agency noted that it is not identifying individual biomarkers or developing any tests, but rather, the project is meant to help accelerate medical technology innovation through the development of common methodologies and tools that can reduce the risks of early product development and aid product design.

该机构指出，它并没有识别单个生物标志物或开发任何测试，而是旨在通过开发可以降低早期产品开发风险和帮助产品设计的通用方法和工具来帮助加速医疗技术创新。

It also noted that no funding amounts are attached to research collaboration agreements..

它还注意到，研究合作协议中没有资金数额。。

In addition, the FDA and the Bill and Melinda Gates Foundation announced in June a partnership with similar goals of identifying analytical methods that could aid the development of breath-based diagnostic tests.

此外，美国食品和药物管理局（FDA）与比尔和梅琳达·盖茨基金会（Bill and MelindaGates Foundation）在6月份宣布了一项合作伙伴关系，其目标类似，即确定可以帮助开发基于呼吸的诊断测试的分析方法。

Owlstone officials, including Boyle, wrote in an article published earlier this year in the journal Metabolomics that about 1,500 VOCs have been identified from breath samples, yet endogenous VOCs in breath have not yet been used as biomarkers in clinical testing. Without standardized methods to collect and analyze breath samples, the production of reliable VOC data has been challenging..

包括Boyle在内的Owlstone官员在今年早些时候发表在《代谢组学》杂志上的一篇文章中写道，已经从呼吸样本中鉴定出约1500种挥发性有机物，但呼吸中的内源性挥发性有机物尚未被用作临床测试中的生物标志物。没有标准化的方法来收集和分析呼吸样本，可靠的VOC数据的产生一直是一个挑战。。

'If the association between the production of VOCs in the body, their presence in breath, and the relationships between specific VOCs and physiological states are established, this could support breath as a robust metabolomic platform for clinical biomarker analysis, similar to blood, urine, and fecal sampling,' the authors wrote..

作者写道：“如果确定了体内挥发性有机化合物的产生，它们在呼吸中的存在以及特定挥发性有机化合物与生理状态之间的关系，这可能会支持呼吸作为临床生物标志物分析的强大代谢组学平台，类似于血液，尿液和粪便采样。”。。

Among the challenges, the authors said that contamination can originate from ambient air or testing equipment, and untargeted breath biomarker discovery studies have resulted in tentatively identified VOCs that can be misidentified through differences in methodologies and instrumentation compared to the reference libraries.

在这些挑战中，作者表示，污染可能来自环境空气或测试设备，非目标呼吸生物标志物发现研究已经导致初步确定的挥发性有机化合物，与参考文库相比，通过方法和仪器的差异可能会被错误识别。

A multitude of researchers has worked on the detection of lung cancer through VOCs, yet 'there are currently no clinically validated breath biomarkers or tests suitable for lung cancer screening due to historical issues with standardization.'.

许多研究人员致力于通过挥发性有机化合物检测肺癌，但“由于标准化的历史问题，目前还没有临床验证的呼吸生物标志物或适合肺癌筛查的测试。”。

Other firms have also recently reported progress in bringing to market tests that use breath samples and mass spectrometry to identify disease. Maryland-based biodefense and medical device firm Zeteo Tech, for example, recently reported the completion of a proof-of-concept study on the use of mass spectrometry to identify protease biomarkers that are associated with lower respiratory tract infections.

其他公司最近也报道了在上市测试方面取得的进展，这些测试使用呼吸样本和质谱来识别疾病。例如，总部位于马里兰州的生物防御和医疗器械公司Zeteo Tech最近报道了一项关于使用质谱法鉴定与下呼吸道感染相关的蛋白酶生物标志物的概念验证研究的完成。

Tampa, Florida-based startup Detect Ion said in August it had forged a partnership with the Moffitt Cancer Center for the development of tests that use mass spec to identify VOC biomarkers for the early detection of lung cancer..

位于佛罗里达州坦帕市的初创公司Detect Ion于8月表示，它已与莫菲特癌症中心建立合作伙伴关系，开发使用质谱鉴定VOC生物标志物以早期发现肺癌的测试。。

Connecticut-based startup DiagMetrics, meanwhile, has been developing infectious disease and critical care tests that use exhaled breath condensate and molecules to bind with targets, and biosensors. University of Minnesota spinout Vocxi Health also has been developing a breath-based lung cancer test, although the firm is using biosensors for the detection of VOCs..

与此同时，位于康涅狄格州的初创公司DiagMetrics一直在开发传染病和重症监护测试，这些测试使用呼出的呼气冷凝液和分子与靶标和生物传感器结合。明尼苏达大学（University of Minnesota）推出的Vocxi Health也一直在开发一种基于呼吸的肺癌检测方法，尽管该公司正在使用生物传感器检测VOCs。。

Owlstone has developed its Breath Biopsy platform for the detection of VOCs using its ReCiva Breath Sampler for the capture of VOCs on breath in cartridges that contain sorbent tubes and GC-MS for biomarker identification. In 2021, the firm launched from its UK lab a breath-based digestive health testing service that uses gas chromatography to detect concentrations of hydrogen and methane biomarkers to aid the diagnosis of conditions including small intestine bacterial overgrowth and carbohydrate absorption issues.

Owlstone开发了呼吸活检平台，用于检测挥发性有机化合物，使用其ReCiva呼吸采样器捕获含有吸附管的墨盒中呼吸的挥发性有机化合物，并使用GC-MS进行生物标志物鉴定。2021年，该公司从其英国实验室推出了一项基于呼吸的消化健康测试服务，该服务使用气相色谱法检测氢气和甲烷生物标志物的浓度，以帮助诊断包括小肠细菌过度生长和碳水化合物吸收问题在内的疾病。

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The company also recently launched its FDA-registered OMED Breath Analyzer, which is available in the UK and US for the quantitative measurement of hydrogen and methane in breath to aid the monitoring of digestive health and treatment progress.

该公司最近还推出了FDA注册的OMED呼吸分析仪，该分析仪可在英国和美国用于定量测量呼吸中的氢和甲烷，以帮助监测消化系统健康和治疗进展。

Boyle said that Owlstone expects to launch in the UK late this year its Libra test for the early detection of liver cirrhosis through the metabolism of limonene in the liver. The test involves drinking a beverage containing limonene, and 40 minutes later, the patients with impaired liver function will have elevated limonene concentrations in their breath..

博伊尔说，猫头鹰石预计今年晚些时候将在英国推出Libra测试，通过肝脏中柠檬烯的代谢早期发现肝硬化。该测试涉及饮用含有柠檬烯的饮料，40分钟后，肝功能受损的患者呼吸中柠檬烯浓度升高。。

'If someone has chronic liver disease, then the concentration of that chemical on the breath should be much higher compared to those that are healthy,' he said.

他说：“如果有人患有慢性肝病，那么与健康人相比，呼吸中这种化学物质的浓度应该要高得多。”。

With the FDA approval this year of Madrigal Pharmaceuticals' Rezdiffra (resmetirom) as a treatment for metabolic dysfunction-associated steatohepatitis (MASH), also known as nonalcoholic steatohepatitis (NASH), 'it becomes more pressing that you're able to identify those people that do have chronic liver disease so they can be selected for therapy,' he said.

他说，随着今年FDA批准将Madrigal Pharmaceuticals的Rezdiffra（resmetirom）用于治疗代谢功能障碍相关脂肪性肝炎（MASH），也称为非酒精性脂肪性肝炎（NASH），你能够识别那些患有慢性肝病的人，以便他们可以被选择接受治疗，这变得更加紧迫。

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He said that existing blood tests for MASH are not very sensitive, and Libra has comparable performance to imaging-based alternatives.

他说，现有的MASH血液检测不是很敏感，Libra的性能与基于成像的替代品相当。

The company also has an ongoing Phase II clinical study for its lung cancer screening test that would be used for early detection in high-risk asymptomatic patients. The commercial test will use inhaled D5-ethyl-βD-glucuronide as a probe for lung cancer. The tumor-associated enzyme β-glucuronidase will metabolize the probe into D5-ethanol that can be detected as a signal that a tumor is present..

该公司还在进行肺癌筛查试验的II期临床研究，该试验将用于高危无症状患者的早期发现。商业测试将使用吸入的D5-乙基-βD-葡萄糖醛酸作为肺癌的探针。肿瘤相关酶β-葡萄糖醛酸酶将探针代谢成D5乙醇，可以检测出肿瘤存在的信号。。

Boyle said that blood-based early cancer detection tests are used for the detection of biomarkers that can be shed in miniscule amounts during early stages of the disease and may be absent from a sample. Owlstone, in contrast, has taken a similar approach to the methods used in a PET scan of introducing a substrate with enhanced uptake in a tumor..

博伊尔说，基于血液的早期癌症检测测试用于检测生物标志物，这些生物标志物在疾病的早期阶段可以少量脱落，并且可能不存在于样本中。相比之下，猫头鹰石（Owlstone）对PET扫描中使用的方法采取了类似的方法，即在肿瘤中引入具有增强摄取的底物。。

'We're trying to take that same principle and say, 'Why don't we introduce a chemical probe that goes to the tumor and is targeting the specific mechanism of the tumor and then releases a signal molecule?'' he said.

“我们试图采用同样的原理，并说，‘我们为什么不引入一种化学探针，该探针进入肿瘤并针对肿瘤的特定机制，然后释放信号分子？’。

The firm also announced in August that it had received a $5 million equity investment and $1.5 million in grant funding from the Gates Foundation to support the identification of breath-based biomarkers of tuberculosis and HIV and test development. Additionally, it said in May 2023 it had inked a contract with the US Department of Defense to develop its handheld instrument for the detection of bacterial and viral respiratory diseases in challenging environments..

该公司还于8月宣布，已收到盖茨基金会的500万美元股权投资和150万美元赠款，用于支持结核病和艾滋病毒呼吸生物标志物的鉴定和测试开发。此外，该公司表示，2023年5月，它与美国国防部签订了一份合同，开发其手持仪器，用于在具有挑战性的环境中检测细菌和病毒性呼吸道疾病。。

Boyle said that Owlstone is focused on the initial launch of its tests within the UK followed by expansion into the US. He expects that the firm's Libra test will be available in the US in 2026.

博伊尔表示，猫头鹰石公司专注于在英国首次推出测试，然后扩展到美国。他预计该公司的天秤座测试将于2026年在美国推出。

For now, the company is working with the FDA to move the field of breath-based testing forward by helping to set standards for the discovery and confirmation of endogenous biomarkers. Boyle said that he expects, however, that Owlstone's approach of using exogenous probes to generate and analyze a detectable signal will for the next few years provide an easier path for companies in the space to bring tests to market..

目前，该公司正在与FDA合作，通过帮助制定内源性生物标志物的发现和确认标准，推动基于呼吸的检测领域向前发展。然而，博伊尔表示，他预计，在未来几年内，Owlstone使用外源探针生成和分析可检测信号的方法将为该领域的公司将测试推向市场提供一条更容易的途径。。

'We're more likely to see tests on the market if those approaches are adopted,' he said.

他说，如果采用这些方法，我们更有可能在市场上看到测试。