““The primary challenge in exhaled breath diagnostics is to establish a precise correlation between exhaled breath composition and disease status.”Dr. Sun Meixiu, who has been engaged in research on respiratory gas analysis technology and diagnostics for over 10 years and has published more than 20 SCI papers as the first/corresponding author and obtained more than 20 patents, said.

Dr. Sun Meixiu earned her doctoral degree from Nankai University and completed her postdoctoral research at the National University of Singapore. Currently, Dr. Sun serves as a Research Fellow at the Institute of Biomedical Engineering, Chinese Academy of Medical Sciences & Peking Union Medical College. In 2021, driven by the mission to promote the translation of scientific research achievements, Dr. Sun co-founded Wanyingmei (Tianjin) Health Technology Co., Ltd. (hereinafter referred to as “Wanyingmei”) with Professor Li Yingxin and investor Ma Wanli.

According to reports, Wanyingmei has accumulated a solid research foundation in mass spectrometry, spectroscopy, and sensor-based detection of exhaled breath, as well as in the development of auxiliary diagnostic models. The company has innovatively pioneered a non-invasive metabolomics-based diagnostic method for diseases using “direct injection mass spectrometry combined with machine learning classification models.” Within just two years, it launched a Class II medical device certified by the National Medical Products Administration—the Exhaled Breath Analyzer—providing LDT (Laboratory Developed Tests) early lung cancer screening and health warning services based on breath metabolomics to physical examination centers, healthcare institutions, communities, enterprises, and individuals.

Many volatile organic compounds (VOCs) in human exhaled breath originate from endogenous physiological and pathological processes within the human body.

During pathological processes, alterations in cellular metabolism lead to changes in volatile organic compounds (VOCs). Pathological mechanisms associated with cancer, including hypoxia, excessive cell proliferation, heightened inflammation, and increased reactive oxygen species activity, cause significant changes in the types and concentrations of VOCs both locally and systemically. This indicates that VOCs can provide a comprehensive assessment of human physiological and pathological conditions. Due to their simplicity, non-invasiveness, and low cost, VOCs hold promise as important biomarkers for early disease detection and continuous monitoring.

According to Dr. Sun Meixiu, the clinical adoption of exhaled volatile organic compounds (VOCs) as a diagnostic method will inevitably undergo three stages. The first stage involves using mass spectrometry-based technologies to identify disease biomarkers and establish correlations between exhaled breath and specific diseases, which she describes as “a long-term process of continuous validation.” The second stage entails developing ultra-sensitive, miniaturized technologies targeted at specific disease biomarkers to achieve low-cost, portable solutions. The third stage requires collaborative efforts with relevant institutions to promote widespread education among clinicians, thereby facilitating the clinical application of breath-based diagnostics. At this point, the focus will be on addressing specific local needs, continuously driving improvements in the accuracy and resolution of exhaled breath analysis technologies.

The emergence of Wanyingmei is closely tied to the contemporary imperative of breath analysis—serving as a robust complement to clinical diagnostics. To accelerate the clinical translation of breath analysis, Wanyingmei, recognized as the “national team” in this field, was established.

In terms of its founders’ backgrounds alone, Wanyingmei boasts an R&D team led by Dr. Sun Meixiu and Professor Li Yingxin. Professor Li previously served as Deputy Director of the Institute of Biomedical Engineering at the Chinese Academy of Medical Sciences and as Chairman of the Laser Medicine Branch of the Chinese Medical Association. He currently serves as a member of the National Medical Device Technical Advisory Committee (Active Devices) and as a member of the National Subcommittee for Standardization of Medical Optics and Instruments. He has spearheaded numerous national research projects and facilitated the commercialization of more than 20 scientific and technological achievements.

Furthermore, Wanyingmei’s financing and operations division is led by Ma Wanli, a seasoned investor with over 20 years of experience in private equity fund management. His expertise helps address critical bottlenecks in Wanyingmei’s commercialization and market-oriented operations.

“The National Team” is further evidenced by the scale of its domestic clinical trials. It is understood that Wanyingmei has established robust collaborative partnerships with numerous Grade A tertiary hospitals, including Tianjin Medical University Cancer Institute and Hospital, Tianjin Chest Hospital, Tianjin Haihe Hospital, and General Hospital of Tianjin Medical University, as well as with multiple universities and research institutions. Notably, its progress in prospective clinical studies on exhaled breath screening and diagnosis for lung cancer is leading globally.““A Study on Exhaled Breath VOCs Profiles of Pulmonary Diseases with a Sample Size of 10,000 Cases Is Underway”。

This team, a “national team” that has been tracking and researching internationally leading exhaled breath analysis technologies since 2012, has more importantly mastered the technological edge.

Exhaled VOCs can be used for disease diagnosis and are closely associated with high-precision detection technologies. The concentrations of VOCs in exhaled breath are typically extremely low, reaching levels as low as parts per million (ppm) or even parts per billion (ppb), necessitating the use of highly sensitive instruments for their detection.

Proton Transfer Reaction Time-of-Flight Mass Spectrometry (PTR-TOFMS) is an internationally leading direct-injection mass spectrometry analysis technology, featuring a mass resolution exceeding 10,000, high sensitivity, high selectivity, an ultra-low limit of detection (<10 ppt), and high throughput. Leveraging this technology, Wanyingmei developed the “Exhaled Breath Analyzer” (Tianjin Medical Device Registration No. 20232070288) in just one year, making it the second Class II medical device in China for direct-injection mass spectrometry-based exhaled breath metabolomics testing.

Leveraging advanced breath analysis equipment and AI diagnostic models to establish a central testing laboratory, Wanyingmei provides LDT (Laboratory-Developed Test) lung cancer early screening and health warning services based on breath metabolomics through physical examination institutions, medical facilities, communities, enterprises, and individuals.

The diversity of technical approaches has, to some extent, delayed the formation of clinical consensus on the application of exhaled volatile organic compound (VOC) detection in clinical diagnosis. The precise and standardized collection of exhaled breath samples from subjects is an urgent practical challenge that needs to be addressed in disease detection. Therefore, during clinical research, it is necessary to standardize the entire process from sampling to signal generation, covering details such as sampling time, breathing maneuvers, and sample storage. Furthermore, standards must also be established for the data analysis process following signal acquisition.

In Wanyingmei’s standardized LDT model, users need only obtain the collection bag and complete sampling independently; within three days, they will receive health analysis and early warning information for lung cancer and other pulmonary diseases from Wanyingmei’s proprietary testing laboratory, supported by clinical or scientific research findings.

It is worth noting that, in response to the limitations of current lung cancer screening systems—such as insufficient diagnostic capability for pulmonary micronodules (<5 mm), inadequate monitoring capacity for malignant transformation of pulmonary small nodules (5–10 mm), and increased risks associated with cumulative radiation exposure from repeated CT scans—Wanyingmei has developedLung Nodule Malignancy Monitoring Service Based on Exhaled Breath Analysis and NLP (Natural Language Processing) of CT Imaging Reports, patients with pulmonary nodules need only provide the CT imaging report from when the nodule was first detected and undergo regular exhaled breath analysis to achieve continuous tracking and monitoring of pulmonary nodules. This enables early identification of malignant transformation, effectively supplementing and addressing the blind spots of the existing pulmonary nodule monitoring system (based on annual CT scans).

“Exploring and establishing a library of exhaled breath biomarker profiles for various diseases, promoting the standardization of respiratory sampling and analytical methods, thereby enhancing the stability of test results and reducing inter-laboratory variability, represents a higher barrier for enterprises beyond hardware technological barriers. ‘Currently, overseas companies may be ahead in commercialization; however, leveraging our domestic advantages—such as easier access to clinical samples, higher efficiency, and broader coverage in China—we are also among the first tier in areas like clinical data accumulation,’ said Ma Wanli.”

Based on this, Wanyingmei is conducting large-scale clinical cohort validation involving lung cancer, pulmonary nodules, Alzheimer’s disease (AD), and heart failure. “We have entered the re-validation phase, which will inevitably further drive the clinical application of exhaled breath testing in China and support its development in the field of early disease screening. This simple, precise, non-invasive, and portable exhaled breath testing technology has the potential to reshape the current technological landscape of early disease screening and diagnosis,” added Ma Wanli.

Building on its research team’s expertise in mass spectrometric detection of volatile organic compounds (VOCs) in exhaled breath and the development of auxiliary diagnostic models, Wanyingmei innovatively proposed “"Direct Injection Mass Spectrometry + Machine Learning Classification Model" for Exhaled Breath Lung Cancer Screening/Diagnosis, has secured multiple key intellectual property rights and entered Phase III clinical trials.

Currently, based on this research approach, Wanyingmei is fully leveraging the advantages of the “Peking Union Medical College Hospital (PUMCH) network” to conduct multiple large-cohort clinical trials. These include the “Study on Exhaled Breath VOC Profiles in Pulmonary Diseases” conducted in collaboration with Tianjin Chest Hospital (ChiCTR2300075672, n=10,000), which is currently the largest-scale clinical study in China; and the “Research on Screening and Diagnosis of Alzheimer’s Disease Based on Exhaled Breath Analysis Technology” conducted with Tianjin Medical University General Hospital (ChiCTR2300075674).

Furthermore, Wanyingmei is also conducting multiple new clinical research projects on exhaled breath diagnostics for pulmonary nodules, heart failure, and breast cancer.

Ma Wanli pointed out that shifting the focus of cancer prevention and control to earlier stages has become a consensus across all sectors, with early detection, diagnosis, and treatment being particularly crucial. In recent years, national policies have provided strong support for the field of early cancer screening, with multiple significant policies introduced successively. Various regions are leveraging their local advantages to promote the clinical adoption of breath analysis tests; for instance, Beijing has included breath analysis tests in its medical insurance coverage list.

“With the deepening of clinical research and continuous technological upgrades, exhaled breath testing has now become standardized, precise, and intelligent,” said Dr. Sun Meixiu. In the evolution of exhaled breath testing, the first generation—widely adopted in clinical practice—is the 13C/14C urea breath test for Helicobacter pylori; the second generation focuses on inflammation and microbiome analysis; and the third generation enables early screening and diagnosis of major diseases, including lung cancer. It is reported that Wanyingmei’s exhaled breath tests for lung cancer and pulmonary nodules have already achieved standardization, precision, and intelligence.

In the future, Wanyingmei will continue to leverage its technological advantages in exhaled breath analysis in two key areas. First, it will expand the scope and spectrum of early disease diagnosis, gradually extending from pulmonary nodules and lung cancer to multiple other fields such as Alzheimer’s disease (AD) and heart failure. Second, it will broaden the boundaries of its testing services by expanding into related IVD technology R&D, development of medical and consumer-grade devices, health information services for disease warning based on exhaled breath analysis, CRO services for exhaled breath detection clinical trials, and pharmacokinetic analysis services based on exhaled breath analysis.

Currently, Wanyingmei has established reserves in spectroscopic, mass spectrometric, and sensor-based detection technologies for exhaled volatile organic compounds (VOCs). Its fingerprint spectroscopy device for lung cancer has reached the prototype stage, achieving a discrimination rate of 83.4% in internal validation and 68% in external validation, with continuous optimization underway.