Wanyingmei Co-Founder Dr. Sun Meixiu: A Decade of Breath Analysis Innovation Powers Lung Cancer Early Detection with Fingerprint Spectroscopy 'Electronic Nose' System

The Era of Rapid Diagnosis via Breath Analysis Has Arrived.

In April this year, the U.S. FDA granted its first approval for relevant entities to use breath samples for COVID-19 testing, noting that the new method can detect SARS-CoV-2 in breath samples within 3 minutes with an accuracy of up to 91.2%.

With the FDA’s approval of the first breath test for COVID-19, confidence in and recognition of breath testing have significantly increased among clinical practitioners, industry players, and investors.

Recently, affected by ““Science and Technology China” The 2nd High-Value Biomedical Patent Project Selection ActivityAt the invitation of, Arterial Orange Fruit Bureau had the honor of interviewingProfessor Sun Meixiu, Co-Founder of WanyingmeiShe has been engaged in mechanistic research in the field of respiratory gas analysis technology for ten years, publishing more than 20 SCI papers as the first or corresponding author and obtaining over 20 patents.

In this interview, Professor Sun addressed “"Machine Olfaction System Based on Fingerprint Spectroscopy for Early Diagnosis of Lung Cancer", further shared insights on the technological roadmap for breath testing and strategies for translating research achievements into practical applications.

In 2012, Sun Meixiu, upon returning from her studies in Singapore, established China’s first CRDS breath analysis laboratory and developed breath testing technology integrated with artificial intelligence.

In fact, Professor Sun’s team believes that the development of breath analysis diagnostic technology will undergo three stages: The first stage is based on mass spectrometry to accurately identify biomarkers. Following precise identification, the second stage involves developing ultra-sensitive, miniaturized technologies targeting specific biomarkers to achieve low-cost and portable solutions. The third stage is the widespread application of breath testing technology, during which the accuracy and resolution of breath analysis will meet established standards, driven primarily by specific local needs.

Based on these three stages of development, Professor Sun’s team laid out the underlying technologies for the first two generations of products, namely mass spectrometry and spectroscopy. Specifically, the first-generation product featuresEstablishing High-Accuracy Biomarkers as a Key Technical Phase, employing proton-transfer-reaction time-of-flight mass spectrometry (PTR-TOFMS) with high throughput, low detection limits, and real-time quantitative capabilities, combined with artificial intelligence, to detect subtle changes induced by lung cancer lesions.

It is reported that the throughput of mass spectrometry technology has reached a level capable of detecting nearly all volatile organic compounds and pinpointing subtle changes in hundreds of specific compounds.

After the biomarkers were identified, Professor Sun’s team proceeded to lay out their strategic plan.Ultra-Sensitive Cavity Ring-Down Spectroscopy, spectral and band selection are performed for specific substances. Once the biomarkers are identified, the advantages of spectroscopic technology become more pronounced; compared to mass spectrometry, it is more portable and cost-effective, and compared to electrochemical techniques, it offers superior sensitivity.

Currently, research in exhaled breath analysis technology has focused on system development based on a single technique. In contrast, Professor Sun’s team has pursued the dual development of mass spectrometry and spectroscopy technologies, achieving miniaturized systems that meet high-resolution standards.

Last December, Professor Sun, together with Professor Li Yingxin and investor Ma Wanli, co-founded Wanyingmei (Tianjin) Health Technology Co., Ltd.

Judging solely from the founders' backgrounds, Wanyingmei already boasts a team of"National Team" in R&D. First, let us look at the R&D team led by Professor Sun and Professor Li Yingxin. Professor Li previously served as Deputy Director of the Institute of Biomedical Engineering, Chinese Academy of Medical Sciences, and as Chairman of the Laser Medicine Branch of the Chinese Medical Association. He has spearheaded multiple national research projects and successfully commercialized more than twenty scientific achievements into products, demonstrating exceptional strength in both research and development and technology transfer.

Secondly, Wanyingmei also possesses the capability toThe financing department led by investor Ma Wanli. It is understood that Ma Wanli has over 20 years of specialized experience in fund investment and management, enabling him to provide valuable advice on capital raising and asset management, thereby sparing scientists from having to engage in negotiations.

Finally, regarding partners, WanyingmeiEstablished the basic framework in China. It is reported that the team has established strong clinical collaborations with top-tier tertiary hospitals, including Peking Union Medical College Hospital, Cancer Hospital of the Chinese Academy of Medical Sciences (Peking Union Medical College), and Tianjin Medical University Cancer Institute and Hospital.

Furthermore, when discussing the future development prospects of Wanyingmei, Professor Sun’s team conducted an analysis from two perspectives: national policies, and technology and products.

From the perspective of national policy, there is a broad consensus across all sectors on shifting the focus of cancer prevention and control upstream, making early detection, early diagnosis, and early treatment of cancer particularly crucial. In recent years, national policies have provided strong support to the field of early cancer screening, with a series of significant policies being introduced. Between 2016 and 2022, a total of eight policies were issued. For example, according to the "Key Points of the Healthy China Action in 2022" promulgated in 2022, the country is actively advancing pilot programs for the establishment of cancer screening and early diagnosis and treatment centers at the district and county levels, and is summarizing and promoting mechanisms and management models for opportunistic screening of cancers such as upper gastrointestinal cancer.

And inPolicy SupportAmidst a massive influx of capital and rapid technological advancements, the tumor early screening market has also seen an influx of numerous competitors.

So, how can one secure a foothold in the market?

The answer lies in technology and products. First, in terms of technology, Wanyingmei has already leveraged its high-barrier, broadly covering patent portfolio toEstablished High Technical Barriers. It is reported that the company has completed its patent layout for the product, covering key stages of product development and methods of application.

Certainly, the protection of technological achievements has also become a major driving force for the company's development, as evidenced by its rich and tiered product portfolio. It is understood that Wanyingmei’s product lineup includes series for early cancer screening and diagnosis, infectious disease screening and diagnosis, and single-molecule disease screening and diagnosis.

In the field of early-stage cancer detection, Wan Yingmei has specifically targeted lung cancer. Professor Sun stated that the company’s developed breath analyzer for lung cancer screening and diagnosis offers a simple, non-invasive, and efficient solution to address the pain points of existing linear lung cancer screening technologies on the market, such as the high false-positive rate of low-dose computed tomography (LDCT), cumulative radiation exposure, reliance on specialized physicians, limitation to high-risk populations, and high management costs.

Currently, mass spectrometry-based breath analyzers for lung cancer screening and diagnosis have entered pre-registration testing and prospective studies to determine technical requirements, safety, and model validity, and are currentlyApplication for Class III Medical Device Registration Certificate, and the spectral-based portable, low-cost breath testing system has completed validation of its measurement methodology,Prototype development is underway.。

Prof. Sun is a scientist with extensive experience in translational research.

In addition to founding Wanyingmei, she successfully facilitated the commercialization of research achievements worth RMB 6 million, including the translation of a breath-based predictive model for lung cancer screening and certain measurement technologies for breath analysis.

From Professor Sun’s translational experience, we can summarize two key points:

First, “Innovation Requires Enduring the Cold Bench”In the face of cyclical market fluctuations, scientists are often relatively passive, as their R&D efforts typically require 5–10 years before prospects for commercialization become visible. Professor Sun noted that breath-testing technology started relatively late in China. A decade ago, it was difficult for his team’s technology to gain recognition; it remained niche in terms of grant applications, clinical collaborations, and technical partnerships.

Faced with the situation at that time, the team remained steadfast in its direction, continuously accumulating technological expertise while maintaining active communication with the industry to seize every opportunity for commercialization. Therefore, as the breath testing market heated up over the past two to three years, the team capitalized on this trend and formally established Wanyingmei, which is “Entrepreneurship Requires a Warm Hearth“A vivid example.”

Furthermore, the team, from its inception,Clarified positioning, namely, to promote the practical application of the product. At the earliest stage, Professor Sun’s team estimated the difficulties in technology research and development and translation, and established a roadmap: first accumulate research funding, then achieve technological transfer by establishing a company, and finally leverage social capital to facilitate product commercialization.

To this day, the team continues to write the story of translating breath analysis technology into clinical practice, guided by this approach and leveraging its own strengths.