36Kr's first | exhale to detect infectious diseases and cancer, "Bu Rui Technology" received tens of millions of yuan A round of financing

36Kr learned that Shenzhen Burui Biotechnology Co., Ltd. (hereinafter referred to as "Burui Technology") has completed tens of millions of yuan A round of financing, with Primavera Venture Capital leading the investment and Gaoluo Capital following the investment. This round of funds will be used for the development and brand building of its "Human Exhalation Detection Platform" for multiple disease diagnosis software and consumables to apply for NMPA registration, clinical trials, and hospital markets.

Founded in December 2018, Bu Rui Technology is a technology enterprise focusing on breath detection and disease biomarker research, aiming to achieve early screening of malignant tumors and infectious diseases through human breath detection, and provide auxiliary means for the rapid diagnosis of a variety of metabolism-related diseases.

It is worth noting that the platform product "Human Exhalation Detection Mass Spectrometer" product of Burui Technology has obtained NMPA certification in 2021, which is also the world's first human breath detection platform approved for clinical application in the field of breath testing. It is reported that the effectiveness of the product in the field of infectious disease and tumor diagnosis has been preliminarily verified.

As a new type of clinical auxiliary diagnostic means, the analysis and detection of exhaled gas has broad application prospects in the field of medical diagnosis. Parts of the body's metabolism are transported from the bloodstream to the lungs, where they appear in the exhaled gas through gas exchange. Exhaled gas reflects the body's metabolic and pathological conditions, and some substances may even become biomarkers of certain diseases, such as acetone, which is a biomarker of diabetes.

As early as 1970, The Nobel Prize-winning American chemist Linus Pauling used a gas chromatograph (GC) to detect more than 200 volatile organic compounds (VOCs) in human exhalation, which can be used to assess physical health and disease conditions; after more than 50 years of development, the correlation between VOCs and diseases has been supported by hundreds of thousands of clinical samples, such as infectious diseases, chronic inflammation of the airways, lung cancer, cirrhosis, breast cancer and other diseases.

However, in the past, because there was no platform dedicated to exhalation detection, the vast majority of VOCs research was based on the gas chromatography-mass spectrometry (GC-MS) laboratory common platform, which required adsorption enrichment, thermal analysis and desorption, chromatographic separation and mass spectrometry qualitative and quantitative detection of samples, which not only cost high, but also a single sample detection time of up to 2-7 hours, the operation process requires strong professionalism, so that it can only be applied to scientific research. It cannot be productized and promoted on a large scale in clinical scenarios.

According to Wang Dongjian, founder of Burui Technology, in view of the above pain points, Burui Technology has developed a "human exhalation detection mass spectrometer" based on the independently developed single photon ionization-time-of-flight mass spectrometry (SPI-TOFMS) technology, which can realize direct sampling, eliminate adsorption enrichment, heat desorption and chromatographic separation processes, achieve low-cost rapid detection, and completely solve many pain point problems in scientific research VOCs research, making it possible to commercialize breath testing and enter clinical applications on a large scale.

Courtesy of the enterprise

It is reported that the technology was invented by the team of Professor Li Haiyang of the Dalian Institute of Chemical Physics of the Chinese Academy of Sciences, Professor Li Haiyang is a top expert engaged in high-end analytical instruments and online detection research in the mainland, serving as the leader of the rapid separation and inspection research group of the Dalian Institute of Chemical Physics of the Chinese Academy of Sciences, a national second-level researcher and doctoral supervisor.

In fact, in the field of early tumor screening and early diagnosis, 36Kr learned that most of the companies on the market use liquid biopsy, Wang Dongjian believes that in comparison, the use of respiratory testing for clinical diagnosis has multiple advantages such as low cost, good compliance, and rapidity, which is also the key to its large-scale clinical application:

Better compliance: First of all, the biological test material is different, the liquid biopsy uses a blood or serum sample, and the breath test only needs to blow a breath against the sampled air bag.

Lower cost: The detection cost of a single sample of Bu Rui's breath test is mainly a self-developed breath sample collection bag, and the breath component mass spectrogram of the sample is formed after detection, and the diagnosis of the specific disease is completed by spectrogram analysis software, and the marginal cost is very low; liquid biopsy is currently mainly based on genomics and proteomics detection, and the current method cost is much higher.

Better sensitivity and specificity: It is reported that the current preliminary exploration of Bu Rui in the direction of tumor diagnosis shows that the breath test has a very good sensitivity and specificity, but the follow-up needs to be further multicenter large sample verification; liquid biopsy is currently not ideal in the real diagnosis or screening scene, and the sensitivity and specificity are not ideal, and the future will continue to break through.

With a wide range of applicable scenarios, breath testing can also be used in combination with technologies such as genomics, immunomic groups, and proteomes in the future, forming a relationship of complementarity and competition.

Up to now, in the exploration of clinical applications, Burui Technology has done a relatively in-depth job in infectious diseases, including tuberculosis, new crown and other respiratory infectious diseases; it has also explored in the field of lung cancer and esophageal cancer in the field of tumors. Wang Dongjian pointed out that the sensitivity and specificity of the company's technology for the diagnosis of active tuberculosis are more than 90%.

It is reported that the current clinical positive culture of tuberculosis bacillus as the gold standard in the diagnosis of tuberculosis, patients with sputum smear examination, sputum culture examination, lung tissue biopsy can be seen to be positive for mycobacterium tuberculosis, you can confirm the diagnosis of tuberculosis disease; but negative sputum test does not necessarily mean that there is no tuberculosis, if you have other typical symptoms of tuberculosis, you also need to confirm the possibility of negative tuberculosis through other tests. In short, the clinical diagnosis of tuberculosis still has pain points such as difficult diagnosis, long cycle and expensive price, and Burui Technology wants to break through this pain point through its own technology.

As for the future commercialization path, Wang Dongjian said that Bu Rui's "human exhalation detection mass spectrometer" is a platform-type product with strong ductility, and will gradually form a diagnostic and screening product pipeline in the field of infectious diseases and tumors based on this, and promote it through the form of IVD products.

36Kr understands that in the field of breath detection, there are three main mainstream technologies, including mass spectrometry (in addition to the SPI-TOFMS technology made by BuRui, there are PTR-MS and other directions), chromatography (represented by the future of wisdom), and sensor-based research, but only a few are promoted to clinical use. The key reason is that there is an obvious technical bottleneck in the qualitative and quantitative detection of trace-level substances, because the VOCs in human expiratory samples are extremely low despite many types, between 10 12--10 6, which is also the reason for the complex process of "enrichment - high temperature desorption - chromatographic separation - mass spectrometry qualitative and quantitative detection" in previous studies.

At present, BuRui Technology has creatively solved this problem through completely independent research and development technology, realized direct sampling, rapid qualitative and quantitative detection, and has multiple patents (granted) that run through all key technology nodes of the system, as well as dozens of invention patents that have been submitted and accepted.

Wang Dongjian said that now is the best time to apply breath detection technology, because the need has always been there, BuRui Technology has solved the problems of slow breath detection speed, high cost, low flux and complex operation through technological innovation, so that this method can be truly productized and applied in clinical large-scale applications.