YuanSheng Gene Files for IPO: Solving Clinical Pain Points in Infectious Pathogen Detection with Nanopore Sequencing
In recent years, pathogen detection for infectious diseases has emerged as another clinical application hotspot in the field of genetic testing, following reproductive health, genetic disease screening, and tumor mutation profiling. The pandemic has further underscored the clinical demand and investment value of precise pathogen detection. In the post-pandemic era, with heightened public health awareness, genetic testing, as one of the clinical adjuncts for the diagnosis and treatment of infectious diseases, will see increased recognition and more frequent clinical application, leading to an continuous expansion of its clinical use cases.
Yuansheng Kangtai Gene Technology Co., Ltd.(hereinafter referred to as “Yuansheng Gene”) is a biotechnology company specializing in the precise detection of pathogens causing infectious diseases. Established in July 2019 and based in the Zhongguancun Haidian Pioneer Park, the company has developed a domestically leading dual-dimensional real-time precision detection platform for infectious pathogens, capable of issuing test reports within 24 hours.
By leveraging advanced fourth-generation nanopore detection technology, and integrating targeted sequencing, bioinformatics algorithms, intelligent terminals, 5G transmission, big data cloud platforms, and knowledge base technologies,Yuansheng Gene integrates its independently developed sample pre-processing biotechnologies, assay kits, big data analytics, cloud computing, real-time rapid data transmission, AI, and precision applications to provide an integrated service platform solution for the rapid detection of infectious pathogens.This solution comprises three components: data generation, intelligent terminals, and a big-data cloud platform. It not only accelerates testing speed and enables more comprehensive and precise diagnosis of infectious pathogens, but also provides clinicians with access to the latest technologies and knowledge.
Over the past year and a half, the Yuansheng Gene team has secured more than 20 intellectual property achievements in the field of infectious pathogen diagnostic product technologies, including invention patents, software copyrights, and scientific publications related to genetic big data management systems, statistical analysis and processing systems, pathogenic microorganism gene analysis platforms, and nanopore detection technology for novel coronavirus and its applications.
Figure: Selected Invention Patents and Software Copyrights Obtained by Yuansheng Gene (Provided by the Company)
Receiving honors such as “The First Batch of the 14th Science and Technology Leading Talents in Suzhou Industrial Park,” “Third Prize in the Finals of the HiCOOL Global Innovation and Entrepreneurship Competition,” “Second Place in the Biopharmaceutical Sector of the China Zhonghuamen Innovation Competition,” “Top 10 in the Virus Detection Technology Special Session of the 2020 ZGC International Frontier Science and Technology Innovation Competition,” “First Prize in the Maker Category of the ‘Maker Beijing 2020’ Innovation and Entrepreneurship Competition,” and the “Beijing Jinqiao Seed Fund,” among others, signifies the high regard and recognition from all sectors of society for YuanSheng Gene’s capabilities in technological innovation and achievement transformation.
The rapid development of Yuansheng Gene has attracted the attention of multiple investment institutions—Within one year, Yuansheng Gene successively completed three rounds of financing—seed round, angel round, and Pre-A round—with a total funding amount reaching tens of millions of yuan.Currently, Yuansheng Gene has begun its next round of financing. What kind of company is it?
Infectious diseases have long posed a significant threat to public health and remain a major cause of morbidity and mortality worldwide.According to data released by the World Health Organization (WHO), deaths from infectious diseases account for 19% of total global deaths.This represents the most authentic manifestation of shifting infection prevention and control, as well as diagnosis and treatment, to earlier stages, underscoring the importance and urgency of managing infectious diseases. As a typical example of an infectious disease, COVID-19 continues to inflict immense suffering and losses on people worldwide.
The similar clinical manifestations of infectious pathogens, the increase in complex drug-resistant pathogenic microorganisms, and the growing number of immunocompromised hosts have made the situation of infection prevention and control increasingly severe, thereforeEtiological diagnosis remains the most critical component in the diagnosis of infectious diseases.However, existing conventional etiologic diagnostic methods are constrained by numerous limitations—such as complex procedures, time-consuming workflows, and low detection efficiency—and thus fail to meet the need for timely diagnosis of infectious diseases. Consequently, a substantial proportion of patients remain without an identified pathogen, precluding precise anti-infective therapy in clinical practice.
The ability to rapidly and accurately establish an etiologic diagnosis is central to the successful treatment of infectious diseases.YuanSheng Genomics is built upon a top-tier professional team specializing in the precise diagnosis of infectious pathogens. Driven by clinical needs, the company is committed to advancing product development and clinical adoption through expertise and dedication. At this stage, the latest nanopore single-molecule sequencing technology is transitioning from research to clinical practice, holding promise for addressing critical pain points in the diagnosis and treatment of infectious diseases, thereby enabling its clinical application and offering vast market prospects.
According to projections by the Yuansheng Gene team, in the routine infection market, the size of the precision diagnostics market could reach5-10 billion/year. From the perspective of the critical care infection market, based on a future price of RMB 2,000–3,000 per case and a market penetration rate of 60%, the market size for precision diagnostics can reach25-35 billion/year。
Market-oriented and technology-driven, Yuansheng Gene leverages nanopore single-molecule sequencing technology to lead product iteration and upgrades through independent innovation. The company optimizes rapid and precise diagnostic identification of pathogens, antimicrobial resistance genes, and virulence factors, striving to provide superior solutions for clinical pathogen diagnosis, support precision anti-infective therapy, and effectively address clinical needs.
In the biotechnology sector, the biggest challenge for startup teams is talent. The strength of the core team often determines how far a company can go and how fast it can develop.
Dr. Yu Le, Founder and CEO of YuanSheng Gene, studied under a Fellow of the Royal Society of BiologyDave BurtProfessor Yu earned his Ph.D. and completed postdoctoral research in bioinformatics and machine learning in the United Kingdom. He is a Senior Fellow at the Roslin Institute of the University of Edinburgh, the birthplace of Dolly the cloned sheep, and was honored by the Royal Society of Edinburgh as a Leading Scientist of the Scottish Universities Alliance. Dr. Yu also holds the title of Senior Engineer from the Chinese Academy of Sciences, serves as a council member for several medical associations in China, and has published over 100 articles and intellectual property works in prestigious academic journals such as CID, BMC Bioinformatics, Molecular Endocrinology, PLOS Biology, Current Biology, and IEEE.
Dr. Yu Le, Founder and CEO of YuanSheng Genomics
During the early stage of Dr. Yu Le’s career, he served as Chief Scientist and senior executive at Fortune 500 companies such as Shanghai General Motors and Digital China Healthcare, accumulating extensive experience in translating research into practical applications, including medical product development and R&D in big data analytics for genomics.The solid research foundation accumulated during the early stages of his career, coupled with the honing of business management skills, paved the way for his entrepreneurial journey.Throughout different stages of his life, Dr. Yu Le has built a multi-tiered professional network through extensive industry exchanges, which also constituted the initial talent pool for the founding team of Yuansheng Gene.
“YuanSheng Gene’s talent advantage has laid a solid foundation for the company’s robust development,” Dr. Yu Le told VCBeat, noting that the core team members of YuanSheng Gene are all top-tier professionals from the clinical healthcare industry system.With over 10 years of technical expertise and experience in pathogenic microbiology, metagenomics, clinical kit development, and bioinformatics analysis,Most of them are elite returnees.The team members possess a global perspective and technological foresight, enabling them toEffectively align product commercialization with the actual demands of the Chinese market.
With over a decade of sales and marketing experience in the clinical industry, Yuansheng Gene’s front-line business team is fully committed to advancing the clinical application of Yuansheng’s infectious pathogen detection products, accelerating their deployment and promotion across China.
Currently, Yuansheng Gene has established an RT-panel-basedTMNanopore-Targeted Pathogen Detection and PRI-seqTMNanopore metagenomics pathogen detection product portfolio pipeline, to better address clinical needs and practical pain points.
RT-panelTMNanopore-Based Targeted Pathogen Detection Product,The focus lies in detecting pathogens of high clinical concern as outlined in the guidelines for the diagnosis and treatment of infectious diseases, thereby leveraging the advantages of speed, precision, and cost-effectiveness to accurately address the real-world needs of clinical anti-infective therapy. This product is designed not only for patients with complex, critical, or unusual infectious diseases but also benefits a large population of infectious disease patients by facilitating initial pathogen screening.
PRI-seqTMNanopore Metagenomics Pathogen Detection Product,Leveraging the advantages of long-read and real-time sequencing, this approach achieves comprehensive coverage and precise detection with higher sensitivity and specificity. It targets 18,836 pathogens, including bacteria, fungi, parasites, DNA viruses, and RNA viruses, enabling more accurate pathogen detection, genotyping, and antimicrobial resistance gene analysis, particularly facilitating the precise identification of clinically rare or emerging pathogens.
PRI-seqTMPathogen Metagenomics Database
Currently, Yuansheng Gene has established strategic or project collaborations in clinical and scientific research with top-tier medical institutions, including the Guangzhou Institute of Respiratory Health, Peking University Third Hospital, Tsinghua Changgung Hospital, and Shanghai Public Health Clinical Center.
“YuanSheng Genomics has always firmly believed that technological innovation is the core driver of the future for industries in China and around the world, and this holds true for the field of precision medicine. The continuous innovation and integration of hardware equipment, IT, and BT technologies should better address clinical pain points in infectious diseases and achieve commercial implementation,” emphasized Dr. Yu Le. The integrated platform for rapid, precise, and intelligent detection of infectious pathogens developed by YuanSheng Genomics can completeComprehensive departmental coverage of infectious diseases in Respiratory Medicine, ICU, Neurology/Neurosurgery, Pediatrics, Infectious Diseases, Hematology, Transplantation, and Oncology,“Multi-dimensional products can achieve a closed-loop testing chain from pathogen screening, precise detection, to resistance and virulence factor analysis, integrating all-in-one systems to realize ‘“Real-time, on-site, rapid, precise, comprehensive coverage, and cost-effective”diagnosis of infectious pathogens, further enhancing their clinical and commercial value, so that technological advancements benefit the general public.”
According to Dr. Yu Le, 2020 was a pivotal year for Yuansheng Gene, marked by significant achievements. The company provided nanopore-based pathogen detection services to top-tier medical institutions, including the Guangzhou Institute of Respiratory Health, Peking University Third Hospital, Peking University First Hospital, Shougang Hospital, Guangdong Provincial People’s Hospital, and Beijing Tsinghua Changgung Hospital, as well as other regional medical centers across China. To date, it has processed more than 3,000 research and clinical samples.
Following the outbreak of the COVID-19 pandemic, the Yuansheng Gene team joined forces with top medical experts from the Guangzhou Institute of Respiratory Health to rush to the front lines, participating in on-site rapid testing for patients infected with the novel coronavirus and achieving significant results. The joint team successfully developed a rapid test kit for SARS-CoV-2 based on nanopore gene sequencing technology, along with the corresponding analytical and detection protocols, within a very short period.The product demonstrates significantly higher sensitivity and specificity than PCR, enabling the detection of SARS-CoV-2 in as little as 15 minutes and facilitating the diagnosis of patients with a high clinical suspicion of infection despite negative PCR results.The related research findings were jointly published in the authoritative journal *Clinical Infectious Diseases* (IF = 8.31), and the corresponding core technologies have been granted invention patents.
The image data is sourced from: Li Z, Li Y, Chen L, et al. A confirmed case of SARS-CoV-2 pneumonia with routine RT-PCR negative and virus variation in Guangzhou, China[J]. Clinical Infectious Diseases, 2020
Subsequently, the Guangzhou Institute of Respiratory Health, the National Clinical Research Center for Respiratory Diseases, and Yuansheng Gene established a nanopore sequencing and analysis platform for respiratory tract infection pathogens, aiming to better serve clinical practice and investigate the in-depth application of pathogen detection in disease diagnosis, treatment, and drug development. Yuansheng Gene successfully secured major national, provincial, and municipal projects focused on the establishment and clinical application research of a rapid nanopore detection platform for respiratory pathogens.
Regarding the company’s future development plans, Dr. Yu Le stated, “The development of diagnostic products for infectious pathogens based on fourth-generation nanopore sequencing technology is a process of continuous innovation and breakthrough. YuanSheng Gene will further develop its core product technology system and improve its quality control system to achieve intelligent, rapid, full-process pathogen detection for its core products. On this basis, we will swiftly promote the adoption of our testing services in hospital-based testing models. Furthermore, in terms of expanding partnerships, YuanSheng Gene will intensify its efforts by forging strategic alliances with industry leaders to achieve rapid growth in market share and sample testing volume.”
In its future strategic layout, Yuansheng Gene will continue to accelerate the research, development, and iterative upgrading of core product technologies. Meanwhile, in addition to establishing medical testing centers in Beijing and Guangzhou, Yuansheng Gene will collaborate with multiple Grade-A tertiary hospitals to co-establish localized joint laboratories, further advancing the application of nanopore pathogen detection technology to better serve clinical practice and patients. The company will rapidly pursue regulatory approvals for its intelligent all-in-one testing devices, related test reagents, and software, thereby gradually completing the transformation of its business model.
Furthermore, Yuansheng Gene will provide big data-based services to governments, pharmaceutical companies, medical AI enterprises, hospitals, and universities in the form of data-derived services. As a company with an international development perspective, Yuansheng Gene will leverage the opportunities presented by the Belt and Road Initiative to extend its product reach overseas, further developing markets in Southeast Asia and beyond.