NEW YORK – With the launch of a multi-center clinical trial, Canadian biotech firm Breathe BioMedical said that it is developing a breath-based test to help identify breast cancer in patients whose mammography results are difficult to interpret due to dense breast tissue.

纽约——随着一项多中心临床试验的启动，加拿大生物技术公司 Breathe BioMedical 表示，他们正在开发一种基于呼吸的测试，以帮助识别那些因乳腺组织密集而难以通过乳房 X 光检查结果解释的乳腺癌患者。

The Moncton, New Brunswick-based firm announced late last month it was partnering with researchers at George Washington University Breast Center along with two investigators from the Mayo Clinic on an observational study with up to 1,000 patients that will use infrared spectroscopy and machine learning to identify breath-based volatile organic compounds (VOCs) that are biomarkers of breast cancer.

总部位于新不伦瑞克省蒙克顿的公司上月末宣布，将与乔治华盛顿大学乳腺中心的研究人员以及梅奥诊所的两名研究人员合作，开展一项观察性研究，涉及多达1000名患者。该研究将利用红外光谱和机器学习技术，识别作为乳腺癌生物标志物的基于呼吸的挥发性有机化合物 (VOC)。

The research will help the company to refine its test as an adjunct to mammography for the detection of early-stage breast cancer in patients with dense breast tissue..

该研究将有助于公司完善其作为乳腺X光检查辅助手段的测试，以便检测乳腺组织致密的患者的早期乳腺癌。

Breathe BioMedical CEO Bill Dawes said early study results show that the company's test would be equally useful in patients with high- or low-density breast tissue, but the firm has focused on the use of the test in women with dense breast tissue because of a need in the market for better methods to stratify those patients by breast cancer risk.

Breathe BioMedical首席执行官比尔·道斯表示，早期研究结果显示，该公司的检测方法对高密度或低密度乳腺组织的患者同样有用，但由于市场上需要更好的方法来根据乳腺癌风险对密集乳腺组织的女性进行分层，公司专注于在这一人群中的检测应用。

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About half of US women over the age of 40 have dense breast tissue. The US Food and Drug Administration began requiring in September that mammography results include notification if a patient's breasts are classified as dense, including a statement that dense tissue makes cancers more difficult to detect on a mammogram and other imaging-based tests may aid the discovery of cancers..

大约一半的40岁以上美国女性有致密的乳腺组织。美国食品和药物管理局从九月开始要求，如果患者的乳房被归类为致密型，乳房X光检查结果必须包括通知，声明致密组织会使癌症在乳房X光片及其他影像测试中更难以检测，其他基于影像的测试可能有助于发现癌症。

Patients with dense breast tissue also have an

具有致密乳腺组织的患者 также имеют

increased risk of breast cancer

乳腺癌风险增加

, although research has not found an increased risk of breast cancer death in patients with dense breasts, according to the National Cancer Institute.

，然而根据美国国家癌症研究所的说法，研究并未发现乳腺密度高的患者有更高的乳腺癌死亡风险。

In an article

在一篇文章中

published this week in

本周发布在

JAMA

美国医学会杂志

, a pair of authors from the University of Washington and University of California Los Angeles noted that prior studies have raised concerns about the potential for discordant assessments of dense breast tissue in mammograms. However, digital mammography and digital breast tomosynthesis perform well in detecting breast cancer in women with dense breasts, and prior research has shown that digital breast tomosynthesis could in some patients reduce false-positive results and improve breast cancer detection in comparison with digital mammography..

，来自华盛顿大学和加利福尼亚大学洛杉矶分校的两位作者指出，先前的研究已经引发了对乳腺X光片中致密乳腺组织评估可能存在差异的担忧。然而，数字乳腺X线摄影和数字乳腺断层合成在检测致密乳房女性的乳腺癌方面表现良好，并且先前的研究表明，与数字乳腺X线摄影相比，数字乳腺断层合成在某些患者中可以减少假阳性结果并提高乳腺癌的检测率。

Breathe BioMedical's breath testing platform includes its tabletop SohnoXB breath sampler that could be used at the point-of-care to collect samples onto sorbent tubes. Dawes said that collecting the breath sample requires about the same amount of effort as a person would use to cool a spoonful of soup..

Breathe BioMedical的呼吸测试平台包括其台式SohnoXB呼吸采样器，可在护理点使用，将样本收集到吸附管中。Dawes表示，采集呼吸样本所需的力气大约相当于一个人吹凉一勺汤所用的力气。

The sorbent tubes are heated to specified temperatures and transferred into the company's proprietary infrared cavity ring-down spectrometer, which is used to generate a breath spectrograph based on laser light absorption of analytes in the sample, including VOCs. An algorithm is used to identify biomarker-based patterns of breast cancer..

吸附管被加热到指定温度，并转移到该公司专有的红外腔衰荡光谱仪中，该仪器用于根据样品中分析物（包括挥发性有机化合物）对激光吸收的情况生成呼吸光谱图。一种算法用于识别基于生物标志物的乳腺癌模式。

The results of Breathe BioMedical's test are used to help determine which patients would proceed to downstream imaging such as ultrasound or MRI. The authors of the

Breath BioMedical的测试结果用于帮助确定哪些患者会进行下游成像，如超声波或核磁共振成像。该

JAMA

美国医学会杂志

article wrote that decisions whether to perform supplemental screening with MRI or ultrasonography should be based on comprehensive risk assessment rather than breast density alone.

文章写道，是否使用核磁共振成像或超声波进行补充筛查的决定应基于全面的风险评估，而不是仅仅基于乳腺密度。

Meanwhile, some other research teams have reported success in identifying breath-based VOCs that could be used for the detection of breast cancer.

同时，其他一些研究团队报告称，他们成功识别出了可用于检测乳腺癌的基于呼吸的挥发性有机化合物（VOC）。

In 2020, researchers from China wrote in the

2020年，中国研究人员在

Journal of Clinical Laboratory Analysis

临床实验室分析杂志

that they had identified seven breast cancer-specific VOCs that differed between breast cancer patients and controls as well as between breast and gastric cancer patients. Two years later, scientists in Japan wrote in the

他们已经识别出七种乳腺癌特有的挥发性有机化合物，这些化合物在乳腺癌患者与对照组以及乳腺癌患者与胃癌患者之间存在差异。两年后，日本的科学家在

Journal of Breath Research

呼吸研究杂志

that they had found that they could discriminate between breath samples from patients with and without breast cancer through differences in concentrations of the three VOCs 3,7-dimethyl-2,6-octadien-1-ol, ethanolamine, and ethyl nonanoate.

他们发现，通过三种挥发性有机化合物——3,7-二甲基-2,6-辛二烯-1-醇、乙醇胺和乙基壬酸酯——的浓度差异，可以区分乳腺癌患者和非乳腺癌患者的呼吸样本。

Another research group from Mexico also reported in 2020 in the

另一个来自墨西哥的研究小组也在2020年报告了

Journal of Breath Research

呼吸研究杂志

that an 'electronic nose' with polymer-based sensors to detect changes in electrical resistance could be used to identify overall patterns of VOCs that are distinctive for patients with breast cancer.

基于聚合物传感器的“电子鼻”可用于检测乳腺癌患者特有的挥发性有机化合物总体模式，这种传感器通过检测电阻变化来工作。

As for the broader breath testing space, a handful of firms has been developing breath-based tests for cancer, other chronic diseases, and infectious diseases. Cambridge, UK-based Owlstone Medical, for example, has been

至于更广泛的呼吸测试领域，已有少数公司一直在开发基于呼吸的癌症、其他慢性疾病和传染病检测方法。例如，英国剑桥的Owlstone Medical公司一直在

developing a menu of tests

开发测试菜单

that use VOCs, starting with the early detection of liver disease followed by a test for early detection of lung cancer. However, the firm is developing its breath-based tests for endogenous markers of disease as well as signals that are produced following the consumption or inhalation of VOC probes.

这些测试使用挥发性有机化合物（VOCs），首先是早期肝病检测，随后是早期肺癌检测。然而，该公司正在开发基于呼吸的测试，用于检测疾病的内源性标志物以及在摄入或吸入VOC探针后产生的信号。

Owlstone declined to comment for this article..

Owlstone 拒绝就本文发表评论。

The FDA's Center for Devices and Radiological Health also

FDA的设备和放射健康中心也

announced last year

去年宣布的

it was partnering with the Bill and Melinda Gates Foundation on research into analytical methods that could be used to advance breath-based diagnostic tests, with a goal of bringing efficient and affordable testing options into rural and remote areas.

它正与比尔和梅琳达·盖茨基金会合作，研究可用于推进基于呼吸的诊断测试的分析方法，目标是将高效且价格实惠的检测选项引入农村和偏远地区。

Dawes said that the company previously studied the use of its technology for non-small cell lung cancer and COVID-19–related pneumonia but it has been focused on breast cancer for the past 18 months. He said that it is much easier to run a clinical trial on the use of the technology for the detection of breast cancer in part because many more patients undergo breast cancer screening compared to NSCLC..

道斯表示，公司之前曾研究过将其技术用于非小细胞肺癌和与新冠相关的肺炎，但在过去 18 个月里，公司一直专注于乳腺癌研究。他说，部分原因是进行乳腺癌筛查的患者数量远远多于非小细胞肺癌，因此针对乳腺癌检测技术应用的临床试验更容易开展。

Breathe BioMedical reported in 2023 at the American Society of Clinical Oncology annual meeting that it found in a proof-of-concept study that an early version of its breast cancer test performed with upward of 88.2 percent accuracy, with 92.9 percent sensitivity and 80 percent specificity. He said that the number of VOCs that were used in that analysis is proprietary..

Breathe BioMedical 在 2023 年美国临床肿瘤学会年会上报告称，其在一项概念验证研究中发现，其早期版本的乳腺癌测试准确率高达 88.2%，灵敏度为 92.9%，特异性为 80%。他表示，该分析中使用的挥发性有机化合物 (VOC) 的数量是专有的。

Dawes said that the company collects upward of 800 data points from each patient sample, although he expects that the amount of data will be reduced with refinement of the company's testing model and the identification of a small number of VOCs that form the signal for breast cancer. In the observational study, Dawes said that the company will use deep learning to develop a model, and he thinks that the breast cancer signal could consist of five, 10, or 20 VOCs..

道斯表示，公司从每位患者的样本中收集多达 800 个数据点，尽管他预计随着公司测试模型的改进和确定构成乳腺癌信号的少量挥发性有机化合物 (VOC)，数据量将会减少。在观察性研究中，道斯表示公司将使用深度学习来开发模型，他认为乳腺癌信号可能由五种、十种或二十种挥发性有机化合物组成。

While the firm intends to use machine learning to identify markers of disease, Dawes said the results will not include details on the individual VOCs that are identified with the test.

虽然该公司打算使用机器学习来识别疾病的标志物，但道斯表示，结果不会包括通过测试识别出的个别挥发性有机化合物 (VOC) 的详细信息。

'In our go-to-market efforts, it's not our intent to unpack the sample and say 'This is what's there, this is why it's there, and this is how it correlates to underlying disease,'' he said. 'Our intent is to say 'Our data and our machine learning algorithms have identified the presence of disease.''.

“在我们进入市场的努力中，我们的目的并不是拆解样本并说‘这就是存在的东西，这就是它存在的原因，以及它如何与潜在疾病相关联’，”他说。“我们的目的是说‘我们的数据和机器学习算法已经识别出疾病的存在。’”。

He said that the test is simple, noninvasive, and inexpensive, and he expects that the company will be able to secure reimbursement for the test. He added that the test also could improve testing access for women who are recommended for imaging-based follow-up to mammography but have travel, scheduling, or payment issues, among other barriers..

他说，该测试简单、无创且价格低廉，他预计公司能够为该测试获得报销。他补充说，该测试还可以改善那些被建议进行基于影像的乳腺X光摄影后续检查、但存在旅行、时间安排或支付问题等其他障碍的女性的检测机会。

'We believe that the payors will pay for it,' Dawes said. 'We believe that the institutions will find capacity for it, and we believe that women will find their way to the tests because they have a cancer signal.'

“我们认为支付者会为此买单，”道斯说。“我们相信医疗机构会为此找到空间，我们也相信女性会因为癌症信号而找到接受检测的途径。”

Dawes said the test's cost is expected to be equivalent to the cost of mammography.

道斯说，该测试的费用预计与乳房X光检查的费用相当。

The company had filed in June 2024 a

该公司于2024年6月提交了

preliminary prospectus

初步招股说明书

for an initial public offering with the US Securities and Exchange Commission, but the company said in October it had decided against pursuing the IPO and

向美国证券交易委员会提交首次公开募股，但该公司在十月份表示已决定不进行此次公开募股，并且

filed for withdrawal

申请撤回

of its registration statement. The firm said that it decided against the IPO due to market conditions and a determination that registering its securities would not be in its best interests.

其注册声明。该公司表示，由于市场状况以及确定注册其证券不符合其最佳利益，因此决定放弃首次公开募股（IPO）。

In its prospectus, the company said that it planned to complete in 2025 verification and validation studies for components of its breath cancer breath test. The firm also said it planned for a pivotal trial in 2026 to support an application in 2027 for US Food and Drug Administration pre-market approval.

公司在其招股说明书中表示，计划在2025年完成对其呼气癌症检测组件的验证和确认研究。该公司还表示，计划在2026年进行关键试验，以支持其在2027年提交美国食品和药物管理局（FDA）上市前批准申请。

If the test gains acceptance in the US and Canada, the firm plans to develop a network of labs to analyze breath samples..

如果这项测试在美国和加拿大获得认可，该公司计划建立一个实验室网络来分析呼吸样本。

The firm noted in the SEC filing that it had 13 patents in the US and three in Canada as well as 64 pending patent applications in the US, Canada, EU, Australia, China, India, and Japan.

该公司在SEC文件中指出，其在美国拥有13项专利，在加拿大拥有3项专利，同时在美国、加拿大、欧盟、澳大利亚、中国、印度和日本还有64项正在申请的专利。

The company noted in the SEC filing that it had developed its SohnoXB breath sampler and its spectrometer with funding support from the Atlantic Canadian Opportunities Agency and the National Research Council's Industrial Research Assistance Program. The collection device is registered with the FDA and Health Canada.

公司在SEC文件中指出，它在大西洋加拿大机会局和国家研究委员会工业研究援助计划的资助下，开发了其SohnoXB呼吸采样器和光谱仪。该采集设备已在FDA和加拿大卫生部注册。

.

。

Because the company is training its model to identify VOCs that are not specific to dense breast tissue, Dawes thinks that the test eventually could be used as a first-line screening test. He said that the firm is almost exclusively focused on breast cancer testing, although he said that the firm anticipates the use of the technology next to develop of tests for other women's health-related cancers such as ovarian and cervical cancers, with other cancers, viral diseases, and chronic disease tests to follow..

由于该公司正在训练其模型以识别非特定于致密乳腺组织的挥发性有机化合物，道斯认为该测试最终可以用作一线筛查工具。他说，公司几乎完全专注于乳腺癌检测，尽管他表示，公司预计下一步将利用该技术开发针对其他与女性健康相关的癌症（如卵巢癌和宫颈癌）的检测方法，随后还将开发其他癌症、病毒性疾病和慢性病的检测方法。

As for the breast cancer test, Dawes said that Breathe BioMedical plans to continue partnering with academic institutions on clinical studies and publishing study results to gain traction in the medical community. He said that the firm has been working for more than a year on its market plans with a focus on securing reimbursement for the test..

至于乳腺癌测试，道斯表示，Breathe BioMedical 计划继续与学术机构合作开展临床研究，并发布研究成果，以在医学界获得认可。他说，该公司已花费一年多的时间制定市场计划，重点是确保测试的报销事宜。

Dawes said that the use of the breast cancer test could reduce healthcare spending, and he thinks that the self-insured corporate market will find value for the test through its identification of cancers in early stages when patients have a higher likelihood of survival and the cost of treatment is lower.

道斯表示，使用乳腺癌测试可以减少医疗支出，他认为自保企业市场会通过早期发现癌症的价值来认可这项测试，因为在早期阶段，患者的生存几率更高且治疗成本更低。

The current clinical trial will provide data to support those discussions, he said..

他说，当前的临床试验将提供数据以支持那些讨论。

'The economics work for this test, which is why we're going to be focusing on the payors as part of our market launch,' he said.

“这次试验的经济效应良好，所以我们将在市场发布时重点关注支付方，”他说道。